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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brachytherapy (100/110)
Brachytherapy (125/145)
External Beam Radiation Therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate T1c-T2b, N0, M0 Intermediate-risk disease, as defined by 1 of the following: Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL Gleason score 7 AND PSA < 10 ng/mL No evidence of distant metastases Prostate volume ≤ 60 cc by transrectal ultrasonography American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed) PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Patients must use effective contraception No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site No major medical or psychiatric illness that would preclude study therapy No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Prior neoadjuvant hormonal therapy allowed provided the following are true: Therapy was initiated within 2-6 months of study enrollment Therapy was no more than 6 months in duration Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration No concurrent hormonal therapy Radiotherapy No prior pelvic radiotherapy Surgery No prior radical surgery for prostate cancer No prior transurethral resection of the prostate No prior cryosurgery Other No prior transurethral needle ablation of the prostate No prior transurethral microwave thermotherapy of the prostate

Sites / Locations

  • Arizona Oncology Services Foundation
  • Auburn Radiation Oncology
  • Alta Bates Summit Comprehensive Cancer Center
  • Peninsula Medical Center
  • Radiation Oncology Centers - Cameron Park
  • Mercy Cancer Center at Mercy San Juan Medical Center
  • East Bay Radiation Oncology Center
  • Valley Medical Oncology Consultants - Castro Valley
  • Valley Medical Oncology
  • California Cancer Center - Woodward Park Office
  • Kaiser Permanente Medical Center - Hayward
  • Contra Costa Regional Medical Center
  • El Camino Hospital Cancer Center
  • Sutter Health - Western Division Cancer Research Group
  • Alta Bates Summit Medical Center - Summit Campus
  • Bay Area Breast Surgeons, Incorporated
  • CCOP - Bay Area Tumor Institute
  • Larry G Strieff MD Medical Corporation
  • Tom K Lee, Incorporated
  • Kaiser Permanente - Division of Research - Oakland
  • Kaiser Permanente Medical Center - Oakland
  • Kaiser Permanente Medical Center - Rancho Cordova
  • Kaiser Permanente Medical Center - Redwood City
  • Kaiser Permanente Medical Center - Richmond
  • Rohnert Park Cancer Center
  • Kaiser Permanente Medical Center - Roseville
  • Radiation Oncology Center - Roseville
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • Mercy General Hospital
  • South Sacramento Cancer Center
  • South Sacramento Kaiser-Permanente Medical Center
  • Kaiser Permanente Medical Center - Sacramento
  • Kaiser Permanente Medical Center - San Francisco Geary Campus
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • California Pacific Medical Center - California Campus
  • Kaiser Permanente Medical Center - Santa Teresa
  • Kaiser Foundation Hospital - San Rafael
  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  • Kaiser Permanente Medical Center - Santa Rosa
  • Kaiser Permanente Medical Center - South San Francisco
  • Kaiser Permanente Medical Facility - Stockton
  • Solano Radiation Oncology Center
  • Sutter Solano Medical Center
  • Kaiser Permanente Medical Center - Walnut Creek
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • Hospital of Saint Raphael
  • CCOP - Christiana Care Health Services
  • Sibley Memorial Hospital
  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • Northeast Georgia Medical Center
  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  • Cancer Institute at St. John's Hospital
  • Regional Cancer Center at Memorial Medical Center
  • Menorah Medical Center
  • CCOP - Kansas City
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • St. Agnes Hospital Cancer Center
  • Cape Cod Hospital
  • Shields Radiation Oncology Center - Mansfield
  • South Suburban Oncology Center
  • Winchester Hospital Radiation Oncology Center
  • Hickman Cancer Center at Bixby Medical Center
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Foote Memorial Hospital
  • Sparrow Regional Cancer Center
  • St. Mary Mercy Hospital
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • St. John Macomb Hospital
  • Mayo Clinic Cancer Center
  • Saint Luke's Cancer Institute at Saint Luke's Hospital
  • St. Joseph Medical Center
  • North Kansas City Hospital
  • Parvin Radiation Oncology
  • Research Medical Center
  • Liberty Hospital
  • Heartland Regional Medical Center
  • Saint Joseph Oncology, Incorporated
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Barnes-Jewish West County Hospital
  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
  • CCOP - Nevada Cancer Research Foundation
  • Nevada Cancer Institute
  • Renown Institute for Cancer at Renown Regional Medical Center
  • Kingsbury Center for Cancer Care at Cheshire Medical Center
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
  • New York Methodist Hospital
  • Roswell Park Cancer Institute
  • Sands Cancer Center
  • Beth Israel Medical Center - Petrie Division
  • Highland Hospital of Rochester
  • University Radiation Oncology at Parkridge Hospital
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Coleman Radiation Oncology Center at Carter General Hospital
  • CarolinaEast Cancer Care
  • South Atlantic Radiation Oncology, LLC
  • Coastal Carolina Radiation Oncology Center
  • Summa Center for Cancer Care at Akron City Hospital
  • Radiation Oncology Center
  • Barberton Citizens Hospital
  • Adena Regional Medical Center
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Medical Center Cancer Care
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Community Cancer Center
  • Hematology Oncology Center
  • Lima Memorial Hospital
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Northwest Ohio Oncology Center
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • St. Charles Mercy Hospital
  • Cancer Care Center, Incorporated
  • North Coast Cancer Care, Incorporated
  • Community Hospital of Springfield and Clark County
  • Flower Hospital Cancer Center
  • Mercy Hospital of Tiffin
  • Toledo Hospital
  • St. Vincent Mercy Medical Center
  • Medical University of Ohio Cancer Center
  • CCOP - Toledo Community Hospital
  • St. Anne Mercy Hospital
  • Toledo Clinic, Incorporated - Main Clinic
  • Mount Carmel St. Ann's Cancer Center
  • Cancer Treatment Center
  • Genesis - Good Samaritan Hospital
  • Geisinger Cancer Institute at Geisinger Health
  • Fox Chase Cancer Center - Philadelphia
  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  • York Cancer Center at Apple Hill Medical Center
  • M. D. Anderson Cancer Center at University of Texas
  • Sandra L. Maxwell Cancer Center
  • Logan Regional Hospital
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center - East Campus
  • Utah Cancer Specialists at UCS Cancer Center
  • LDS Hospital
  • Norris Cotton Cancer Center - North
  • Fredericksburg Oncology, Incorporated
  • Veterans Affairs Medical Center - Richmond
  • St. Francis Hospital
  • Good Samaritan Cancer Center
  • Franciscan Cancer Center at St. Joseph Medical Center
  • CCOP - Northwest
  • MultiCare Regional Cancer Center at Tacoma General Hospital
  • Columbia Saint Mary's Hospital - Ozaukee
  • Columbia-Saint Mary's Cancer Care Center
  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
  • All Saints Cancer Center at Wheaton Franciscan Healthcare
  • West Allis Memorial Hospital
  • Cross Cancer Institute at University of Alberta
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EBRT + Brachytherapy

Brachytherapy Only

Arm Description

External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)

Transperineal interstitial permanent brachytherapy (125/145)

Outcomes

Primary Outcome Measures

5-Year Freedom From Progression Rate
A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.

Secondary Outcome Measures

Biochemical Failure Rate (Protocol Definition)
Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Biochemical Failure (Phoenix Definition)
Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Prostate Cancer Death
Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported.
Local Failure
Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Distant Metastases
Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported.
Overall Survival
Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported.
Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]
Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to based.
Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]
Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring > 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported.
Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months.
Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months.
Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.
Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months
The EQ5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.

Full Information

First Posted
July 8, 2003
Last Updated
February 28, 2023
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT00063882
Brief Title
Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
Official Title
A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
Detailed Description
OBJECTIVES: Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT). Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens. Compare morbidity and quality of life of patients treated with these regimens. Determine the feasibility of collecting Medicare data in a large Radiation Therapy Oncology Group (RTOG) prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT. Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds. Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years. After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
588 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBRT + Brachytherapy
Arm Type
Experimental
Arm Description
External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
Arm Title
Brachytherapy Only
Arm Type
Active Comparator
Arm Description
Transperineal interstitial permanent brachytherapy (125/145)
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy (100/110)
Intervention Description
100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy (125/145)
Intervention Description
125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
EBRT
Intervention Description
Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.
Primary Outcome Measure Information:
Title
5-Year Freedom From Progression Rate
Description
A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
Time Frame
From randomization to 5 years
Secondary Outcome Measure Information:
Title
Biochemical Failure Rate (Protocol Definition)
Description
Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Time Frame
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Title
Biochemical Failure (Phoenix Definition)
Description
Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Time Frame
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years.
Title
Prostate Cancer Death
Description
Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported.
Time Frame
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Title
Local Failure
Description
Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Time Frame
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Title
Distant Metastases
Description
Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported.
Time Frame
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Title
Overall Survival
Description
Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported.
Time Frame
From randomization to last follow-up. Analysis occurs after all patients had been on study for at least 5 years. Maximum follow-up at time of analysis was 13.9 years.
Title
Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]
Description
Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to based.
Time Frame
Zero to 180 days from the start of radiation
Title
Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]
Description
Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring > 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported.
Time Frame
From 181 days after the start of radiation to last follow-up. Maximum follow-up at time of analysis was 13.9 years.
Title
Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months
Description
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months.
Time Frame
Baseline and 4 months after start of radiation
Title
Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months
Description
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months.
Time Frame
Baseline and 24 months after start of radiation
Title
Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months
Description
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
Time Frame
Baseline and 4 months after start of radiation
Title
Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months
Description
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
Time Frame
Baseline and 24 months after start of radiation
Title
Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months
Description
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.
Time Frame
Baseline and 4 months after start of radiation
Title
Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months
Description
The EQ5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.
Time Frame
Baseline and 24 months after start of radiation
Other Pre-specified Outcome Measures:
Title
Feasibility of Collecting Medicare Data in a Large RTOG Prostate Cancer Clinical Trial for Cost Effectiveness and Cost Utility Analysis of Combined Treatment With Interstitial Brachytherapy and External Beam Radiotherapy
Time Frame
Analysis occurs after all patients have been potentially followed for 5 years.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate T1c-T2b, N0, M0 Intermediate-risk disease, as defined by 1 of the following: Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL Gleason score 7 AND PSA < 10 ng/mL No evidence of distant metastases Prostate volume ≤ 60 cc by transrectal ultrasonography American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed) PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Patients must use effective contraception No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site No major medical or psychiatric illness that would preclude study therapy No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Prior neoadjuvant hormonal therapy allowed provided the following are true: Therapy was initiated within 2-6 months of study enrollment Therapy was no more than 6 months in duration Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration No concurrent hormonal therapy Radiotherapy No prior pelvic radiotherapy Surgery No prior radical surgery for prostate cancer No prior transurethral resection of the prostate No prior cryosurgery Other No prior transurethral needle ablation of the prostate No prior transurethral microwave thermotherapy of the prostate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley R. Prestidge, MD
Organizational Affiliation
Bon Secours Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Oncology Services Foundation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Auburn Radiation Oncology
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Facility Name
Alta Bates Summit Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Peninsula Medical Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Radiation Oncology Centers - Cameron Park
City
Cameron Park
State/Province
California
ZIP/Postal Code
95682
Country
United States
Facility Name
Mercy Cancer Center at Mercy San Juan Medical Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
East Bay Radiation Oncology Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology Consultants - Castro Valley
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
California Cancer Center - Woodward Park Office
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Kaiser Permanente Medical Center - Hayward
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553-3156
Country
United States
Facility Name
El Camino Hospital Cancer Center
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Sutter Health - Western Division Cancer Research Group
City
Novato
State/Province
California
ZIP/Postal Code
94945
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Breast Surgeons, Incorporated
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Larry G Strieff MD Medical Corporation
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Tom K Lee, Incorporated
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Kaiser Permanente - Division of Research - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Medical Center - Rancho Cordova
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Kaiser Permanente Medical Center - Redwood City
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Permanente Medical Center - Richmond
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Rohnert Park Cancer Center
City
Rohnert Park
State/Province
California
ZIP/Postal Code
94928
Country
United States
Facility Name
Kaiser Permanente Medical Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Radiation Oncology Center - Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Incorporated
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
South Sacramento Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
South Sacramento Kaiser-Permanente Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente Medical Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente Medical Center - San Francisco Geary Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
California Pacific Medical Center - California Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Teresa
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Foundation Hospital - San Rafael
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Kaiser Permanente Medical Center - South San Francisco
City
South San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente Medical Facility - Stockton
City
Stockton
State/Province
California
ZIP/Postal Code
95210
Country
United States
Facility Name
Solano Radiation Oncology Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Sutter Solano Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente Medical Center - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Hospital of Saint Raphael
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Cancer Institute at St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
CCOP - Kansas City
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
St. Agnes Hospital Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Cape Cod Hospital
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Shields Radiation Oncology Center - Mansfield
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
South Suburban Oncology Center
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Winchester Hospital Radiation Oncology Center
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Hickman Cancer Center at Bixby Medical Center
City
Adrian
State/Province
Michigan
ZIP/Postal Code
49221
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Cancer Institute at Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Joseph Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
North Kansas City Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Parvin Radiation Oncology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Liberty Hospital
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Joseph Oncology, Incorporated
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish West County Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Renown Institute for Cancer at Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Kingsbury Center for Cancer Care at Cheshire Medical Center
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Sands Cancer Center
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424
Country
United States
Facility Name
Beth Israel Medical Center - Petrie Division
City
New York
State/Province
New York
ZIP/Postal Code
10003-3803
Country
United States
Facility Name
Highland Hospital of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University Radiation Oncology at Parkridge Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14626
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Coleman Radiation Oncology Center at Carter General Hospital
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
CarolinaEast Cancer Care
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28560
Country
United States
Facility Name
South Atlantic Radiation Oncology, LLC
City
Supply
State/Province
North Carolina
ZIP/Postal Code
28462
Country
United States
Facility Name
Coastal Carolina Radiation Oncology Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Summa Center for Cancer Care at Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Radiation Oncology Center
City
Alliance
State/Province
Ohio
ZIP/Postal Code
44601
Country
United States
Facility Name
Barberton Citizens Hospital
City
Barberton
State/Province
Ohio
ZIP/Postal Code
44203
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Community Cancer Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Hematology Oncology Center
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Lima Memorial Hospital
City
Lima
State/Province
Ohio
ZIP/Postal Code
45804
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Northwest Ohio Oncology Center
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537-1839
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
St. Charles Mercy Hospital
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Cancer Care Center, Incorporated
City
Salem
State/Province
Ohio
ZIP/Postal Code
44460
Country
United States
Facility Name
North Coast Cancer Care, Incorporated
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Flower Hospital Cancer Center
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Mercy Hospital of Tiffin
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Medical University of Ohio Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
St. Anne Mercy Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Toledo Clinic, Incorporated - Main Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Mount Carmel St. Ann's Cancer Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
York Cancer Center at Apple Hill Medical Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Sandra L. Maxwell Cancer Center
City
Cedar City
State/Province
Utah
ZIP/Postal Code
84720
Country
United States
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Facility Name
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Norris Cotton Cancer Center - North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
Country
United States
Facility Name
Fredericksburg Oncology, Incorporated
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Veterans Affairs Medical Center - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
St. Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Good Samaritan Cancer Center
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Franciscan Cancer Center at St. Joseph Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-3004
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
MultiCare Regional Cancer Center at Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Columbia Saint Mary's Hospital - Ozaukee
City
Mequon
State/Province
Wisconsin
ZIP/Postal Code
53097
Country
United States
Facility Name
Columbia-Saint Mary's Cancer Care Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
All Saints Cancer Center at Wheaton Franciscan Healthcare
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Facility Name
West Allis Memorial Hospital
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Cross Cancer Institute at University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

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