A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 48
- Locations
- 8
- Primary Endpoint
- quality of life
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
quality of life
Time Frame: Up to 10 years
Secondary Outcomes
- Morbidity(Up to 10 years)
- Disease specific survival(Up to 10 years)
- Disease free survival(Up to 10 years)
- tumor recurrence(Up to 10 years)