Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with androgen deprivation therapy may kill more prostate cancer cells.

PURPOSE: This randomized phase III trial is studying how well giving radiation therapy together with androgen deprivation therapy works in treating patients who have undergone surgery for prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Collaborator: Canadian Cancer Trials Group
• Treatments: Androgens; Bicalutamide; Goserelin; Leuprolide

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Diagnosis of nonmetastatic adenocarcinoma of the prostate

• Must have undergone radical prostatectomy

• Post-operative serum prostate-specific antigen (PSA) < 0.4 ng/mL

• No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA > 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)

Exclusion criteria:

• Known distant metastases from prostate cancer

• PSA > 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)

PATIENT CHARACTERISTICS:

• No other active malignancy likely to interfere with protocol treatment or follow-up

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics

• Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures

• 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies

Exclusion criteria:

• Prior hormone therapy

• Bilateral orchidectomy

• Prior pelvic radiotherapy

• Neoadjuvant treatment

• Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression