At a glance
ClinicalIndex Comparison Record- ✓Prior radical prostatectomy with pelvic lymphadenectomy for pT3N0 prostate cancer, or pT2 pN0 with positive inked resection margin, at least 12 weeks before entry
- ✓PSA between 0.2 and 4.0 ng/mL at entry
- ✓No clinical evidence of disease on physical exam or imaging
- ✓Bone scan within 16 weeks prior to entry showing no metastatic disease
- ✕Pathologic stage pT2 without positive inked resection margin (unless biopsy-proven recurrence)
- ✕Pathologic lymph node stage pN1 or greater
- ✕PSA >4.0 ng/mL at entry
- ✕Prior hormonal therapy after prostatectomy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE
In Brief
A Phase 3 clinical trial evaluating bicalutamide, radiation therapy, and 1 other intervention for Prostate Cancer. Completed, enrolled 840 participants across 240 sites in 2 countries.
Detailed Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
Study Details
Timeline
Interventions
One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra.
One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.