Cyproterone Acetate in Treating Patients With Newly Diagnosed Stage III or Stage IV Prostate Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving cyproterone acetate continuously is more effective than giving cyproterone acetate after tumor progression in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well it works when given continuously or after tumor progression in treating patients with newly diagnosed stage III or stage IV prostate cancer.

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

Details

• Lead Sponsor: St. Bartholomew's Hospital
• Treatments: Cyproterone; Cyproterone Acetate; Hormones

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• T3 -T4, M0-M1 (stage III or IV disease)

• Prostate-specific antigen level ≥ 4 ng/mL and ≤ 100 ng/mL

PATIENT CHARACTERISTICS:

• Performance status 0-2

• Normal liver function

• No other neoplasia (except skin, excluding melanoma)

• No expected difficulties of follow-up related to psychiatric disorders, marked senility, or too large a distance between patient's home and investigator's center

• No severe chronic disease

PRIOR CONCURRENT THERAPY:

• No prior hormonal therapy or chemotherapy

• No prior surgery (radical prostatectomy), except transurethral resection, for M0 patients

• No prior radiotherapy to the primary tumor for M0 patients