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Radiation Therapy in Treating Patients With Stage II Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
70.2 Gy 3D-CRT/IMRT
79.2 Gy 3D-CRT/IMRT
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 adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Clinical stage T1b-T2b Meets one of the following criteria: Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL Gleason score 7 AND PSA < 15 ng/mL No regional lymph node involvement No distant metastases PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer No other major medical or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: At least 3 months since prior finasteride No other prior hormonal therapy, including: Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) Antiandrogens (e.g., flutamide or bicalutamide) Estrogens (e.g., diethylstilbestrol) No concurrent (neoadjuvant or adjuvant) hormonal therapy Radiotherapy: No prior pelvic irradiation or brachytherapy Surgery: No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer No prior surgical castration (bilateral orchiectomy) Other: At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)

Sites / Locations

  • Veterans Affairs Medical Center - Long Beach
  • Radiological Associates of Sacramento Medical Group, Incorporated
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Washington Cancer Institute at Washington Hospital Center
  • Bay Medical
  • Methodist Medical Center of Illinois
  • Oncology Center at Saint Margaret Mercy Healthcare Center
  • Cancer Center at Ball Memorial Hospital
  • Providence Medical Center
  • Lawrence Memorial Hospital
  • Menorah Medical Center
  • Johnson County Radiation Therapy
  • Shawnee Mission Medical Center
  • Lucille P. Markey Cancer Center at University of Kentucky
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Central Maryland Oncology Center
  • Veterans Affairs Medical Center - Ann Arbor
  • University of Michigan Comprehensive Cancer Center
  • Foote Memorial Hospital
  • West Michigan Cancer Center
  • Breslin Cancer Center at Ingham Regional Medical Center
  • William Beaumont Hospital - Royal Oak Campus
  • CentraCare Clinic - River Campus
  • Regional Cancer Center at Singing River Hospital
  • Independence Regional Health Center
  • Truman Medical Center - Hospital Hill
  • Saint Luke's Cancer Institute at Saint Luke's Hospital
  • Kansas City Cancer Center at St. Joseph's Medical Mall
  • St. Joseph Medical Center
  • North Kansas City Hospital
  • Parvin Radiation Oncology
  • CCOP - Kansas City
  • Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
  • Heartland Regional Medical Center
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Saint Mary's Regional Medical Center
  • Cancer Institute of New Jersey at Cooper University Hospital - Camden
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Lovelace Medical Center - Downtown
  • Veterans Affairs Medical Center - Brooklyn
  • New York Methodist Hospital
  • Roswell Park Cancer Institute
  • SUNY Upstate Medical University Hospital
  • Cancer Centers of North Carolina - Raleigh
  • Rex Cancer Center at Rex Hospital
  • Summa Center for Cancer Care at Akron City Hospital
  • Charles M. Barrett Cancer Center at University Hospital
  • Precision Radiotherapy at University Pointe
  • Cancer Treatment Center
  • Bryn Mawr Hospital
  • Cancer Center of Paoli Memorial Hospital
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • MNAP Oncologic Center
  • Albert Einstein Cancer Center
  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  • Mount Nittany Medical Center
  • CCOP - Main Line Health
  • Lankenau Cancer Center at Lankenau Hospital
  • Thompson Cancer Survival Center
  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • Brooke Army Medical Center
  • Wilford Hall Medical Center
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  • Dixie Regional Medical Center - East Campus
  • LDS Hospital
  • Danville Regional Medical Center
  • Naval Medical Center - Portsmouth
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • Community Memorial Hospital Cancer Care Center
  • Medical College of Wisconsin Cancer Center
  • All Saints Cancer Center at Wheaton Franciscan Healthcare
  • Tom Baker Cancer Centre - Calgary
  • Cross Cancer Institute at University of Alberta
  • CancerCare Manitoba
  • Saint John Regional Hospital
  • Doctor H. Bliss Murphy Cancer Centre
  • Margaret and Charles Juravinski Cancer Centre
  • London Regional Cancer Program at London Health Sciences Centre
  • Northeastern Ontario Regional Cancer Centre
  • Cancer Care Program at Thunder Bay Regional Health Sciences
  • Edmond Odette Cancer Centre at Sunnybrook
  • Hopital Notre-Dame du CHUM
  • McGill Cancer Centre at McGill University
  • Centre Hospitalier Universitaire de Quebec
  • Saskatoon Cancer Centre at the University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

70.2 Gy

79.2 Gy

Arm Description

70.2 Gy 3D-CRT/IMRT

79.2 Gy 3D-CRT/IMRT

Outcomes

Primary Outcome Measures

Overall Survival
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.

Secondary Outcome Measures

Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition
Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.
Disease Specific Survival
Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.
Local Progression
Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
Distant Metastases
Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
Percentage of Participants With Erectile Disfuction at 12 Months
The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or < half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change >= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM < change < SEM; Declined: when change <= SEM.
Quality Adjusted Survival by SQLI
Tumor Control Probability
Normal Tissue Complication Probability

Full Information

First Posted
April 9, 2002
Last Updated
December 27, 2022
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033631
Brief Title
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Official Title
A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
April 2014 (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)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.
Detailed Description
OBJECTIVES: Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy. Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens. Compare the probability of tumor control and normal tissue complications in patients treated with these regimens. Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens. Compare the quality of life, including sexual function, of patients treated with these regimens. Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL but < 20 ng/mL vs Gleason score 7, PSA < 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days). Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days). Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
70.2 Gy
Arm Type
Active Comparator
Arm Description
70.2 Gy 3D-CRT/IMRT
Arm Title
79.2 Gy
Arm Type
Experimental
Arm Description
79.2 Gy 3D-CRT/IMRT
Intervention Type
Radiation
Intervention Name(s)
70.2 Gy 3D-CRT/IMRT
Other Intervention Name(s)
3D conformal radiation therapy, intensity modulated radiation therapy
Intervention Description
Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
Intervention Type
Radiation
Intervention Name(s)
79.2 Gy 3D-CRT/IMRT
Other Intervention Name(s)
3D conformal radiation therapy, intensity modulated radiation therapy
Intervention Description
Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.
Time Frame
From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.
Secondary Outcome Measure Information:
Title
Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition
Description
Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.
Time Frame
From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.
Title
Disease Specific Survival
Description
Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.
Time Frame
From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.
Title
Local Progression
Description
Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
Time Frame
From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Title
Distant Metastases
Description
Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.
Time Frame
From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.
Title
Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity
Description
Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0
Time Frame
From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint
Title
Percentage of Participants With Erectile Disfuction at 12 Months
Description
The International Index of Erectile Function Questionnaire (IIEF) is the primary measure for erectile function (ED). IIEF question number 1 ("How often were you able to get an erection during sexual activity?") is scored from: none/almost never (response 0-1) or < half the time (response 2-3) to most times/almost always/always (response 4-5). A response of 0 to 3 on question number 1 of the IIEF is considered erectile dysfunction.
Time Frame
Twelve months from randomization
Title
Number of Participants With Improved, Stable, and Declined Spitzer Quality of Life Index (SQLI) at 12 Months
Description
The SQLI measures quality of life for patients with cancer and other chronic diseases. Possible scores range from 0 to 10, with higher scores indicating a better outcome. Change from Baseline is defined as 12 month SQLI - baseline SQLI and is classified as follows: Improvement: when change >= to the standard error of measurement with reliability quotient of 0.5 (SEM); Stable: when -SEM < change < SEM; Declined: when change <= SEM.
Time Frame
Baseline and 12 months from randomization
Title
Quality Adjusted Survival by SQLI
Time Frame
From randomization to 5 years.
Title
Tumor Control Probability
Time Frame
From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.
Title
Normal Tissue Complication Probability
Time Frame
From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Clinical stage T1b-T2b Meets one of the following criteria: Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL Gleason score 7 AND PSA < 15 ng/mL No regional lymph node involvement No distant metastases PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer No other major medical or psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy No concurrent cytotoxic chemotherapy Endocrine therapy: At least 3 months since prior finasteride No other prior hormonal therapy, including: Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) Antiandrogens (e.g., flutamide or bicalutamide) Estrogens (e.g., diethylstilbestrol) No concurrent (neoadjuvant or adjuvant) hormonal therapy Radiotherapy: No prior pelvic irradiation or brachytherapy Surgery: No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer No prior surgical castration (bilateral orchiectomy) Other: At least 3 months since prior finasteride or phytoestrogen preparation (PC-SPES)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff M. Michalski, MD
Organizational Affiliation
Washington University - Saint Louis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Purdy, Ph.D.
Organizational Affiliation
UC Davis
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Deborah W Bruner, Ph.D.
Organizational Affiliation
Emory University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahul Amin, M.D.
Organizational Affiliation
Cedars-Sinai
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
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
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Washington Cancer Institute at Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Bay Medical
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Oncology Center at Saint Margaret Mercy Healthcare Center
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46320
Country
United States
Facility Name
Cancer Center at Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303-3499
Country
United States
Facility Name
Providence Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Johnson County Radiation Therapy
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Shawnee Mission Medical Center
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
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
Central Maryland Oncology Center
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Veterans Affairs Medical Center - Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
CentraCare Clinic - River Campus
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Regional Cancer Center at Singing River Hospital
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Independence Regional Health Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64050
Country
United States
Facility Name
Truman Medical Center - Hospital Hill
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
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
Kansas City Cancer Center at St. Joseph's Medical Mall
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
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
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
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
Saint Mary's Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper University Hospital - Camden
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Lovelace Medical Center - Downtown
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Veterans Affairs Medical Center - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
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
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Cancer Centers of North Carolina - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Rex Cancer Center at Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
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
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Precision Radiotherapy at University Pointe
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Cancer Center of Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
MNAP Oncologic Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
Facility Name
Albert Einstein Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
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
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
CCOP - Main Line Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-6200
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
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
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Naval Medical Center - Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708-2197
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Community Memorial Hospital Cancer Care Center
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
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
Tom Baker Cancer Centre - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute at University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Doctor H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Cancer Care Program at Thunder Bay Regional Health Sciences
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Edmond Odette Cancer Centre at Sunnybrook
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18674684
Citation
Cranmer-Sargison G. A treatment planning investigation into the dosimetric effects of systematic prostate patient rotational set-up errors. Med Dosim. 2008 Autumn;33(3):199-205. doi: 10.1016/j.meddos.2007.06.005.
Results Reference
background
PubMed Identifier
17825932
Citation
Potrebko PS, McCurdy BM, Butler JB, El-Gubtan AS, Nugent Z. Optimal starting gantry angles using equiangular-spaced beams with intensity modulated radiation therapy for prostate cancer on RTOG 0126: a clinical study of 5 and 7 fields. Radiother Oncol. 2007 Nov;85(2):299-305. doi: 10.1016/j.radonc.2007.06.019. Epub 2007 Sep 7.
Results Reference
result
PubMed Identifier
29543933
Citation
Michalski JM, Moughan J, Purdy J, Bosch W, Bruner DW, Bahary JP, Lau H, Duclos M, Parliament M, Morton G, Hamstra D, Seider M, Lock MI, Patel M, Gay H, Vigneault E, Winter K, Sandler H. Effect of Standard vs Dose-Escalated Radiation Therapy for Patients With Intermediate-Risk Prostate Cancer: The NRG Oncology RTOG 0126 Randomized Clinical Trial. JAMA Oncol. 2018 Jun 14;4(6):e180039. doi: 10.1001/jamaoncol.2018.0039. Epub 2018 Jun 14.
Results Reference
derived
Links:
URL
https://nctn-data-archive.nci.nih.gov/
Description
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Learn more about this trial

Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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