Bicalutamide With or Without Enzastaurin in Treating Patients With Prostate Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer
• Hormone-sensitive disease, as evidenced by a serum total testosterone level > 150 ng/dL
• No evidence of metastatic disease on physical exam, CT abdomen/pelvis (or MRI), chest x-ray or CT scan and bone scan within 6 weeks prior to randomization
• Underwent prior definitive surgery or radiotherapy
• Must have evidence of biochemical failure after primary therapy and subsequent progression as determined by 1 of the following:
• Prostate-specific antigen (PSA) ≥ 0.4 ng/mL (in case of radical prostatectomy)
• PSA rise ≥ 2 ng/mL above the nadir PSA (in case of radiotherapy)
• Baseline PSA must be at least 2 ng/mL and no greater than 50 ng/mL
• PSA doubling time (PSADT) < 12 months

PATIENT CHARACTERISTICS:

• ECOG performance status 0 - 1
• Granulocytes ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm^3
• Serum creatinine normal or creatinine clearance ≥ 60 mL/min
• Serum total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• SGOT and SGPT < 2.5 times ULN
• PT/INR normal
• Fertile patients must use effective barrier contraception during and for at least 3 months after completion of study treatment
• No gastrointestinal (GI) tract disease resulting in: inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to enzastaurin hydrochloride or bicalutamide
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• A history of other malignancy is permitted if the patient is predicted to be disease-free for 2 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 4 weeks since prior salvage therapy with intent to cure (i.e., surgery, radiotherapy, or other local ablative procedures)
• More than 4 weeks since prior prophylactic radiotherapy to prevent gynecomastia
• More than 1 year since prior therapy modulating testosterone levels (such as luteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) unless in the neoadjuvant or adjuvant setting
• No 5 alpha reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements during PSA value collection
• At least 14 days since prior enzyme-inducing anti-epileptic drugs (EIAEDs)
• Patients who must begin EIAED therapy while on study are allowed to remain
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent anticoagulant therapy
• Low dosage acetyl salicylic acid ≤ 325 mg/day allowed
• No other concurrent investigational agents or anticancer therapy (i.e., chemotherapy, immunotherapy, radiotherapy, surgery for cancer, or experimental medications)
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to enzastaurin or bicalutamide
• Prior neoadjuvant and/or adjuvant therapy ≤ 4 weeks prior to randomization (i.e., hormones, chemotherapy, vaccines, or experimental agents) allowed if PSA rise and PSADT were documented after testosterone level was > 150 ng/dL