A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
- 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
- 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
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.
Primary Purpose: Treatment
Thomas M. Pisansky, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|
|Mayo Clinic||Jacksonville, Florida 32224|