Phase III Randomized Evaluation of Adjuvant Radiotherapy vs No Adjuvant Therapy Following Radical Prostatectomy and Pelvic Lymphadenectomy in Surgical Stage C Adenocarcinoma of the Prostate
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 408
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Randomized phase III trial to compare treatment with or without adjuvant radiation therapy in men with stage III prostate cancer who have had radical prostatectomy and lymphadenectomy recently. Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.
Detailed Description
OBJECTIVES: I. Compare disease-free survival rates of patients randomly assigned to adjuvant external-beam radiotherapy vs. no adjuvant therapy following radical prostatectomy and pelvic lymphadenectomy for surgical Stage C (T3 N0 M0) adenocarcinoma of the prostate. II. Determine the qualitative and quantitative toxicities associated with this adjuvant therapy. OUTLINE: Randomized study. Randomization takes place when the patient is physically able to begin treatment, any time within 16 weeks after surgery. Arm I: Radiotherapy. Irradiation of the prostatic bed using megavoltage equipment with effective photon energies of greater than 4 MV. Arm II: No further treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified