A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 138
- Locations
- 254
- Primary Endpoint
- Rate of late severe GU and GI toxicity
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer.
Detailed Description
OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary (GU) and gastrointestinal (GI) toxic effects of external beam radiotherapy followed by permanent source brachytherapy using interstitial iodine I 125 seeds in patients with intermediate risk, clinically localized adenocarcinoma of the prostate. II. Determine the freedom from prostate specific antigen (PSA) failure, overall survival, disease specific survival, and local and/or distant clinical relapse rates in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6 weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of late severe GU and GI toxicity
Time Frame: Start of radiotherapy to at least 18 months of follow-up
Rate of late severe GU and GI toxicity defined as grade 3-5 GU and GI toxicity based on Common Toxicity Criteria 2.0
Secondary Outcomes
- Rate of acute severe GU and GI toxicity(Nine months from the start of radiotherapy)
- Biochemical Failure(From the date of study entry to the date of first occurrence of PSA failure once by ASTRO definition of 3 years of follow-up been completed for all patients)
- Overall failure(From the date of study entry to the date of death due to any cause)
- Failure rate of clinical progression including local-regional/distant failure(Documented evidence of local progression or regional nodal recurrence or distant disease relapse)