Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer
Eligibility Criteria
INCLUSION CRITERIA; DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Localized disease, meeting 1 of the following staging criteria: Clinical stage T2b (palpable bilateral movement) disease Surgically resectable T3 disease Meets any of the following high-risk* features: PSA ≥ 15 ng/mL Gleason grade ≥ 4+3 (4+3, 4+4, or 5+any, but not 3+4) NOTE: *High risk defined as > 50% chance of failure with local therapy Plans to undergo prostatectomy as primary therapy No evidence of lymph nodes ≥ 2 cm in diameter by pelvic CT scan Scan only required in patients with a PSA ≥ 40 ng/mL No evidence of bone metastases by bone scan PATIENT CHARACTERISTICS: Life expectancy ≥ 10 years Eastern Cooperative Oncology Group (ECOG) performance status 0-2 White blood cell (WBC) > 3,000/mm^3 Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Direct bilirubin normal Alanine aminotransferase (ALT) < 2.0 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase [AP] > 2.5 times ULN) Alkaline phosphatase (AP) < 4.0 times ULN No other serious medical condition that would preclude study treatment No other malignancy within the past 5 years except nonmelanoma skin cancer No peripheral neuropathy ≥ grade 2 No hypersensitivity to drugs formulated with polysorbate 80 No significant contraindications to corticosteroids No history of scleroderma No active inflammatory bowel disease (IBD) or IBD that is being medically treated Inclusion of patients with a remote history of IBD is at the discretion of radiotherapist EXCLUSION CRITERIA; PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior therapy for prostate cancer, including any of the following: Conventional hormonal therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone therapy, antiandrogen therapy, or estrogen therapy) External-beam radiotherapy or brachytherapy Cryotherapy Cytotoxic chemotherapy No prior pelvic radiotherapy
Sites / Locations
- Veterans Affairs Medical Center - Portland
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase I Dose 1-4
Phase II MTD Dose
Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)
Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)