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Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
brachytherapy
radiation therapy
Sponsored by
Alliance for Clinical Trials in Oncology
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 I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, recurrent prostate cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed locally recurrent or persistent prostate adenocarcinoma Locally recurrent disease Prostate-specific antigen (PSA) no greater than 10 ng/mL N0 and M0 (at time of initial diagnosis and at time of local recurrence) Lymph nodes must be negative or will be negative after nodal sampling or dissection More than 18 months after completion of prior external beam radiotherapy Must have had 1 of the following disease characteristics prior to external beam radiotherapy: T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL Must have American Urological Association Symptom Index score no greater than 15 Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL No pubic arch interference of more than 1/3 the prostatic volume determined by transrectal ultrasound or pelvic CT scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 OR ECOG 0-1 Life expectancy: At least 5 years Other: No persistent late intestinal or bladder toxicity grade 2 or greater No other major medical or psychiatric illness that would preclude study No metallic hip prosthesis No other malignancy within the past 5 years except localized basal cell or squamous cell skin cancer No other concurrent illness that would limit life expectancy Suitable for spinal or general anesthesia Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: At least 12 months since prior androgen suppression except goserelin or leuprolide with flutamide or bicalutamide begun within the past 30 days Radiotherapy: See Disease Characteristics No prior external beam radiotherapy doses exceeding 71 Gy to the prostate No prior radionuclide prostate brachytherapy Surgery: No prior transurethral prostate resection No prior prostatectomy or prostatic cryosurgery No prior bilateral orchiectomy Other: No concurrent participation in another medical research study for prostate cancer treatment

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • Mayo Clinic
  • CCOP - Carle Cancer Center
  • CCOP - Iowa Oncology Research Association
  • Mayo Clinic Cancer Center
  • CCOP - Missouri Valley Cancer Consortium
  • Allegheny General Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

brachytherapy + radiation

Arm Description

Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy. Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

Outcomes

Primary Outcome Measures

quality of life

Secondary Outcome Measures

Morbidity
Disease free survival
Disease specific survival
tumor recurrence

Full Information

First Posted
March 8, 2002
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00032006
Brief Title
Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer
Official Title
A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer. PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.
Detailed Description
OBJECTIVES: Determine the nature, intensity, and time course of health-related quality of life changes in patients with locally recurrent prostate adenocarcinoma treated with androgen suppression and transperineal ultrasound-guided brachytherapy after external beam radiotherapy. Determine the morbidity of patients treated with this regimen. Determine the overall survival, disease-free survival, and disease-specific survival of patients treated with this regimen. Determine the clinical patterns of tumor recurrence (i.e., time to local tumor progression or distant failure) and time to biochemical failure of patients treated with this regimen. Determine the post-brachytherapy dosimetric coverage of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive androgen suppression comprising goserelin subcutaneously (as either 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection) OR leuprolide intramuscularly (as 4 one-month depot injections or 1 one-month depot injection and 1 three-month depot injection or 1 four-month depot injection) AND oral flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days. Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy. Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 83-166 patients (83 per cohort) will be accrued for this study within 1.5-3 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 I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
brachytherapy + radiation
Arm Type
Experimental
Arm Description
Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy. Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
quality of life
Time Frame
Up to 10 years
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
Up to 10 years
Title
Disease free survival
Time Frame
Up to 10 years
Title
Disease specific survival
Time Frame
Up to 10 years
Title
tumor recurrence
Time Frame
Up to 10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locally recurrent or persistent prostate adenocarcinoma Locally recurrent disease Prostate-specific antigen (PSA) no greater than 10 ng/mL N0 and M0 (at time of initial diagnosis and at time of local recurrence) Lymph nodes must be negative or will be negative after nodal sampling or dissection More than 18 months after completion of prior external beam radiotherapy Must have had 1 of the following disease characteristics prior to external beam radiotherapy: T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL Must have American Urological Association Symptom Index score no greater than 15 Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL No pubic arch interference of more than 1/3 the prostatic volume determined by transrectal ultrasound or pelvic CT scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 OR ECOG 0-1 Life expectancy: At least 5 years Other: No persistent late intestinal or bladder toxicity grade 2 or greater No other major medical or psychiatric illness that would preclude study No metallic hip prosthesis No other malignancy within the past 5 years except localized basal cell or squamous cell skin cancer No other concurrent illness that would limit life expectancy Suitable for spinal or general anesthesia Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: At least 12 months since prior androgen suppression except goserelin or leuprolide with flutamide or bicalutamide begun within the past 30 days Radiotherapy: See Disease Characteristics No prior external beam radiotherapy doses exceeding 71 Gy to the prostate No prior radionuclide prostate brachytherapy Surgery: No prior transurethral prostate resection No prior prostatectomy or prostatic cryosurgery No prior bilateral orchiectomy Other: No concurrent participation in another medical research study for prostate cancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M. Pisansky, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer

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