Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2012-01-06
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer.

PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.

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

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborators: Eastern Cooperative Oncology Group; Medical Research Council; National Cancer Institute (NCI); Southwest Oncology Group
• Treatments: Androgens; Bicalutamide; Buserelin; Flutamide; Goserelin; Leuprolide; Nilutamide

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of the following:

• T3-4, N0 or NX, M0

• T2, PSA greater than 40 µg/L

• T2, PSA greater than 20 µg/L AND Gleason score at least 8

• Diagnosis made within the past 6 months

• Gleason score and PSA known

• Pelvic lymph nodes must be clinically negative

• Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the pelvis

• Negative needle aspirate required for any lymph node more than 1.5 cm

• If a lymph node dissection was performed, it must be histologically negative

• No small cell or transitional cell carcinoma by biopsy

• No bony metastases by bone scan

PATIENT CHARACTERISTICS:

Age:

• Under 80

Performance status:

• ECOG 0-2

Life expectancy:

• At least 5 years excluding malignancy

Hematopoietic:

• Hemoglobin at least 10.0 g/dL

• WBC at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 2 times upper limit of normal (ULN)

• SGOT and SGPT less than 2 times ULN

• Alkaline phosphatase less than 2 times ULN

• No history of chronic liver disease

Renal:

• Creatinine less than 2 times ULN

Other:

• No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease or severe bladder irritability)

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Prior hormonal therapy within the past 12 weeks allowed provided the following conditions are met:

• Negative bone scan before beginning any hormonal therapy

• Extracapsular extension remains palpable on rectal re-exam

• Baseline PSA known before beginning any hormonal therapy

• At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for benign prostatic hypertrophy

Radiotherapy:

• No prior pelvic irradiation

Surgery:

• No prior radical prostatectomy

• Prior transurethral resection of the prostate allowed

Other:

• No prior cytotoxic anticancer therapy

• No other prior treatment for prostate cancer

• No other concurrent anticancer therapy unless documented disease progression