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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer - NCT00063882-54601A(Clinical Trial 116699)



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City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Prostate Cancer
Purpose: RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
Study summary: OBJECTIVES: - Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT). - Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens. - Compare morbidity and quality of life of patients treated with these regimens. - Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT. - Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds. - Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years. After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - T1c-T2b, N0, M0 - Intermediate-risk disease, as defined by 1 of the following: - Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL - Gleason score 7 AND PSA < 10 ng/mL - No evidence of distant metastases - Prostate volume ≤ 60 cc by transrectal ultrasonography - American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Patients must use effective contraception - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site - No major medical or psychiatric illness that would preclude study therapy - No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Prior neoadjuvant hormonal therapy allowed provided the following are true: - Therapy was initiated within 2-6 months of study enrollment - Therapy was no more than 6 months in duration - Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration - No concurrent hormonal therapy Radiotherapy - No prior pelvic radiotherapy Surgery - No prior radical surgery for prostate cancer - No prior transurethral resection of the prostate - No prior cryosurgery Other - No prior transurethral needle ablation of the prostate - No prior transurethral microwave thermotherapy of the prostate
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Data Source: ClinicalTrials.gov
Date Processed: July 21, 2010
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