Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

• Status: Completed
• Trial end date: 1969-12-31
• 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. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.

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

Details

• Lead Sponsor: UNICANCER
• Collaborator: AstraZeneca
• Treatments: Goserelin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Localized disease treated with surgery only

• pT2, pT3, or pT4

• pN0 or pNx

• No clinical signs of progressive disease

• Prostate-specific antigen (PSA) meeting the following criteria:

• PSA ≤ 0.1 ng/mL after prostatectomy

• PSA ≥ 0.2 ng/mL and < 2 ng/mL at study entry

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Life expectancy ≥ 10 years

• No other cancer in the past 5 years except for treated basal cell skin cancer

• No known pituitary gland adenoma

• No uncontrolled hypertension (i.e., blood pressure ≥ 160 mm Hg systolic and/or 90 mm Hg diastolic)

• No geographical, social, or psychological condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior hormonal therapy

• No prior pelvic radiotherapy

• No prior surgical or chemical castration

• At least 6 months since surgery for biological recurrence

• No other concurrent anticancer therapy