NCT00002874

Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	bicalutamide	One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.
RADIATION	radiation therapy	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.
DRUG	placebo	One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

Timeline

• Start date: 1998-02-01
• Primary completion: 2015-08-01
• Completion: 2022-05-20
• First posted: 2003-01-27
• Last updated: 2022-06-15
• Results posted: 2017-08-18

Locations

240 sites across 2 countries: United States, Canada