This trial is active, not recruiting.

Condition prostate cancer
Treatments bicalutamide, buserelin, cyproterone acetate, docetaxel, estramustine phosphate sodium, flutamide, goserelin acetate, leuprolide acetate, nilutamide, triptorelin, conventional surgery, neoadjuvant therapy, radiation therapy
Phase phase 3
Start date November 2002
Trial size 250 participants
Trial identifier NCT00055731, CDR0000270970, EU-20238, FRE-FNCLCC-GETUG-12/0203


RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. 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 is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Survival rate, in terms of clinical and biological remission at 8 years
time frame:
Prostate-specific antigen level at 3 months
time frame:
Cancer progression as measured by ultrasound
time frame:
Survival without clinical remission
time frame:
Overall survival
time frame:
time frame:
Quality of life
time frame:

Eligibility Criteria

Male participants up to 79 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Locally advanced disease or at high risk for relapse - No clinically or radiologically suspected metastases - Prior lymphadenectomy required - Meets at least 1 of the following criteria for poor prognosis: - Gleason score greater than 7 - T3 or T4 disease - Prostate-specific antigen greater than 20 ng/mL - N1 disease PATIENT CHARACTERISTICS: Age - Under 80 Performance status - ECOG 0-2 Life expectancy - More than 10 years Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - AST and ALT no greater than 1.5 times upper limit of normal (ULN) - Bilirubin no greater than ULN Renal - Creatinine less than 1.6 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular - No uncontrolled or severe cardiovascular disease - No prior thrombosis Pulmonary - No prior pulmonary embolus Other - No active infection - No intolerance to aspirin - No other prior malignancy except basal cell skin cancer - No physical or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - No prior hormonal therapy - No other concurrent hormonal therapy Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No other concurrent anticancer therapy

Additional Information

Official title Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse
Description OBJECTIVES: - Compare the 8-year survival rate, in terms of clinical and biological remission, of patients with locally advanced prostate cancer or with a high risk of relapse treated with neoadjuvant releasing factor agonist therapy and antiandrogen therapy with or without docetaxel and estramustine given before local radiotherapy or prostatectomy. - Compare the prostate-specific antigen level at 3 months in patients treated with these regimens. - Compare cancer progression by ultrasound in patients treated with these regimens. - Compare survival without clinical remission of patients treated with these regimens. - Compare the overall survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (7 or under vs over 7), T stage (T1 or T2 vs T3 or T4), prostate-specific antigen level (20 ng/mL or less vs greater than 20 ng/mL), and lymph node involvement (N0 vs N1 or N2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral antiandrogen therapy comprising nilutamide twice daily or bicalutamide once daily or flutamide 3 times daily or cyproterone 4 times daily. Patients also receive docetaxel IV over 1 hour on day 2 and estramustine on days 1-5. Treatment repeats every 21 days for a total of 4 courses. Patients also receive luteinizing hormone-releasing hormone (LHRH) therapy IV comprising buserelin subcutaneously (SC) every 2 months or triptorelin, leuprolide, or goserelin SC every 3 months. - Arm II: Patients receive antiandrogen and LHRH therapy as in arm I. Beginning approximately 21 days after chemotherapy is completed, patients with N0 disease undergo radiotherapy 5 days a week for 6-7 weeks or radical prostatectomy. Patients with N1 or N2 disease undergo radiotherapy or no further local treatment. Hormonal therapy continues in both arms for 3 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at 3 months, and at 1 year. Patients are followed every 6 months for 5 years. PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this study within 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).