This trial is active, not recruiting.

Condition prostate cancer
Treatments antiandrogen therapy, docetaxel, goserelin acetate, orchiectomy
Phase phase 3
Start date October 2004
Trial size 378 participants
Trial identifier NCT00104715, CDR0000416096, EU-20505, FRE-FNCLCC-GETUG-15/0403


RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Overall survival at 36 months
time frame:
Progression-free survival (biological progression and/or clinical progression) at 24 months
time frame:
Quality of life
time frame:
Treatment costs
time frame:
Toxicity and tolerance
time frame:
Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays
time frame:

Eligibility Criteria

Male participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed prostate adenocarcinoma - Metastatic disease - Measurable or evaluable disease - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - WBC ≥ 2,000/mm^3 - Absolute neutrophil count ≥ 1,000/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present) - AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present) Renal - Creatinine ≤ 150 μmol/L Cardiovascular - No symptomatic coronary disease - No congenital cardiac insufficiency - No New York Heart Association class III or IV cardiovascular disease - No other severe cardiovascular disease Other - No severe peripheral neuropathy - No active infection - No other malignancy within the past 5 years except basal cell skin cancer - No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up - No other serious disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for metastatic prostate cancer - Prior chemotherapy allowed provided all of the following are true: - Chemotherapy was completed > 1 year ago - Prostate-specific antigen level has remained stable - No development of metastases within 1 year after completion of chemotherapy Endocrine therapy - Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer Radiotherapy - More than 4 weeks since prior radiotherapy to metastatic sites Surgery - No prior surgical castration Other - No other concurrent investigational drugs

Additional Information

Official title Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers
Description OBJECTIVES: - Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone. - Compare 24-month progression-free survival (biological progression and/or clinical progression) in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Compare costs of these regimens for these patients. - Compare the tolerability of these regimens in these patients. - Compare the toxicity profile of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy continues until the development of hormone resistance. Within 2 months after initiation of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed. PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).