Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer (DART)

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer Read More

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

  • Localized (N0, M0) disease
  • No small cell or transitional cell carcinoma in the biopsy specimen

• Considered to be at high risk for recurrence based on the presence of at least one of the following adverse prognostic features:

  • T stage ≥ 3a
  • Gleason score ≥ 8
  • Baseline prostate-specific antigen (PSA) > 20 ng/mL
• 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

  • Any lymph node appearing ≥ 1.5 cm on CT scan or MRI must be histologically negative by either needle aspirate or lymph node dissection
• No metastases by chest x-ray and bone scan

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• AST and/or ALT ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Total bilirubin normal
• Serum creatinine ≤ 1.5 times ULN
• Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
• Fertile patients must use effective contraception
• No history of other malignancies, except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor with no evidence of disease for > 5 years
• No serious non-malignant disease resulting in a life expectancy of < 10 years
• No known hypersensitivity to any study medications
• No existing peripheral neuropathy ≥ grade 2
• No bilateral hip replacement prostheses
• No contraindication to pelvic radiotherapy including, but not limited to, inflammatory bowel disease or severe bladder irritability
• No medical condition that would contraindicate the study treatment regimen, including severe respiratory insufficiency, uncontrolled diabetes, or severe hypertension
• No other serious illness or psychiatric or medical condition that would preclude management of the patient according to the study, including active uncontrolled infection or significant cardiac dysfunction

PRIOR CONCURRENT THERAPY:

• Prior androgen suppression therapy allowed provided it was initiated no more than 4 weeks prior to study entry
• At least 4 weeks since prior 5-alpha-reductase inhibitors (e.g., finasteride) for benign prostatic hypertrophy
• No prior cytotoxic anticancer therapy
• No prior chemotherapy for carcinoma of the prostate
• No prior surgical treatment for carcinoma of the prostate, except transurethral resection or bilateral orchiectomy
• No prior pelvic radiotherapy
• No concurrent nilutamide
• No other concurrent investigational drugs
• No other concurrent anticancer therapy (cytotoxic therapy, biologic/immunotherapy, or radiotherapy)