Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Hormones can stimulate the production 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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.

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

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Androgens; Bicalutamide; Estramustine; Etoposide; Etoposide phosphate; Flutamide; Hormones; Paclitaxel; Prolactin Release-Inhibiting Factors; Warfarin

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven prostate cancer at high risk for relapse as determined by either of the following:

• Prostate-specific antigen (PSA) 20-100 ng/mL and Gleason score at least 7 (any T stage)

• Clinical stage at least T2, Gleason score at least 8, and PSA no greater than 100 ng/mL

• Negative lymph nodes

• No metastatic disease

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Zubrod 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• White blood cell (WBC) count of at least 3,000/mm^3

• Platelet count at least 130,000/mm^3

• Hemoglobin at least 11.4 g/dL

Hepatic:

• Aspartate aminotransferase (AST) no greater than 2 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL

Other:

• No other invasive cancer within the past 5 years except superficial nonmelanomatous skin cancer

• No major medical or psychiatric illness that would preclude study participation

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 5 years since prior chemotherapy

Endocrine therapy:

• At least 60 days since prior finasteride for prostatic hypertrophy

• At least 90 days since prior testosterone

• No more than 30 days since initiation of prior pharmacologic androgen ablation for prostate cancer

Radiotherapy:

• No prior pelvic radiotherapy

• No concurrent intensity-modulated radiotherapy

Surgery:

• No prior radical prostatectomy

• No prior cryosurgery for prostate cancer

• No prior orchiectomy