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About
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. It is not yet known whether giving androgen suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer.
CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not be reached.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 7 vs ≥ 8), baseline prostate-specific antigen (PSA) (> 20 ng/mL vs ≤ 20 ng/mL), and participating center. Patients are randomized to 1 of 2 treatment arms.
Patients complete quality of life questionnaires at baseline, periodically during treatment, and then every 6 months for 5 years.
After completion of study treatment, patients are followed at 3 and 6 months, every 6 months for 5 years, and then annually thereafter.
Enrollment
Sex
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Considered to be at high risk for recurrence based on the presence of at least one of the following adverse prognostic features:
Deemed to be an appropriate candidate for chemotherapy, as assessed by a medical oncologist
Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and pelvis
No metastases by chest x-ray and bone scan
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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