DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Stage D0 OR D1 disease (i.e., tumor originally diagnosed as being limited to the
prostate and regional lymph nodes)
- Has a rising PSA value after definitive local therapy (i.e., prostatectomy or
radiotherapy) and no radiographic evidence of disease
- PSA progression after local treatment:
- PSA values for patients after surgery must be >= 0.2 ng/mL, determined by two
measurements, >= 1 month apart and >= 6 months after prostatectomy
- PSA values for patients after radiotherapy must be >= 2.0 ng/mL above the nadir
PSA achieved after radiotherapy, determined by two measurements at 1 month apart
and >= 6 months after completion of the radiotherapy treatment (patients who
received adjuvant or salvage radiotherapy after prostatectomy must have PSA of >=
0.2 ng/mL)
- The first two PSA values, along with a third (study baseline) value must all be
rising (i.e., there must be an overall rising trajectory, such that the third
value cannot be lower than the first value)
- No metastatic disease on baseline bone scan and CT scan of the abdomen/pelvis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy >= 6 months
- WBC >= 3,000/mm^3
- ANC >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin >= 9 g/dL
- Serum creatinine < 1.5 mg/dL OR creatinine clearance >= 60 mL/min for patients with
creatinine levels above normal
- Bilirubin normal
- AST and/or ALT <= 2.5 times upper limit of normal
- Serum total testosterone level >= 150 ng/dL
- No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or
hypokalemia, defined as less than the lower limit of normal despite adequate
electrolyte supplementation
- Fertile patients must use two effective forms of contraception (i.e., barrier
contraception and one other method of contraception) for 1 week before, during, and
for >= 12 months after completion of study treatment
- Able to swallow tablets
- No malabsorption syndrome or other condition that would interfere with intestinal
absorption
- No uncontrolled concurrent illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia other than chronic, stable atrial fibrillation
- Psychiatric illness or social situation that would limit compliance with study
requirements
- Baseline QTcF <= 450 msec
- No serologic positivity for acute hepatitis A, acute or chronic hepatitis B, or acute
or chronic hepatitis C
- No history of liver disease or other forms of hepatitis or cirrhosis
- No HIV-positive patients on combination antiretroviral therapy
- No serious concurrent systemic disorder that would compromise the safety of the
patient or compromise the patient's ability to complete the study, at the discretion
of the investigator
- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to gamma-secretase inhibitor RO4929097 or bicalutamide
- Patients may not donate sperm or blood during or for >= 12 months after completion of
study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from adverse events to < CTCAE grade 2
- At least 3 months since prior and no concurrent androgen-deprivation therapy (ADT)
- Hormone-ablative treatment is only allowed in the neoadjuvant setting or in the
setting of primary or salvage radiotherapy
- No more than 36 months of neoadjuvant/ adjuvant ADT
- More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas
or mitomycin C)
- More than 4 weeks since prior and no concurrent estrogens, estrogen-like substances
(i.e., PC-SPES, saw palmetto, or other herbal product that may contain
phytoestrogens), or any other hormonal therapy (including flutamide, nilutamide,
finasteride, ketoconazole, systemic corticosteroids, megestrol acetate, or
cyproterone acetate)
- No other concurrent investigational agents
- No concurrent medications with narrow therapeutic indices that are metabolized by
cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)
- No concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4
- No other investigational or commercial agents or therapies administered with the
intent to treat the patient's malignancy, including chemotherapy, immunotherapy,
hormonal cancer therapy, radiotherapy, or surgery for cancer
- No concurrent hormonal therapy with a leuteinizing hormone-releasing hormone (LHRH)
agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g., abarelix)
- No concurrent growth factors (e.g., G-CSF), packed RBC transfusions, or platelet
transfusions
- No concurrent medications or food that may interfere with the metabolism of RO4929097
including grapefruit and fresh-squeezed grapefruit juice
