Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed prostate cancer Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago No lymph node-positive prostate cancer No documented metastatic disease CT scan of the abdomen and pelvis negative (within the past 6 months) No bone pain OR negative bone scan (within the past 6 months) ECOG performance status 0-2 Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 9 g/dL Bilirubin normal ALT and AST ≤ 1.5 times upper limit of normal Alkaline phosphatase normal Fertile patients must use effective contraception No peripheral neuropathy > grade 1 No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer No serious illness with a life expectancy of < 5 years No concurrent medical, psychological, or social circumstance that would preclude study compliance No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 Exclusion Criteria: No prior orchiectomy No prior chemotherapy regimen for this disease No prior pelvic radiotherapy No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride Preoperative androgen manipulation for a duration of ≤ 3 months allowed No prior immunotherapy No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) No concurrent herbal or alternative regimens including, but not limited to, any of the following: Saw palmetto PC-SPES Shark cartilage No other concurrent investigational agents No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
Sites / Locations
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Experimental
Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel