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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000069248 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brachytherapy + radiation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Radiation |
| ||
| radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Up to 10 years | |
| Disease free survival | Up to 10 years | |
| Disease specific survival |
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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)
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:
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:
Performance status:
Life expectancy:
Other:
PRIOR CONCURRENT THERAPY:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas M. Pisansky, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States | ||
| Mayo Clinic |
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|
| Up to 10 years |
| tumor recurrence | Up to 10 years |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212-4772 | United States |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay | Wisconsin | 54301 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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