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

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
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
Experimental
brachytherapy + radiation
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.