Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed prostate cancer

- Stage D0 disease

- Tumor originally diagnosed as being limited to the prostate and now having
a rising prostate-specific antigen (PSA) after definitive local therapy

- Must have undergone local treatment via prostatectomy or radiotherapy

- PSA values must be ≥ 0.2 ng/mL as determined by 2 measurements, ≥ 1 month apart
and ≥ 6 months after prostatectomy

- PSA values must be ≥ 2.0 ng/mL as determined by 2 measurements, ≥ 1 month apart
and ≥ 6 months after radiotherapy

- The first two PSA values along with a third 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 by baseline bone scan and CT scan of the abdomen and/or pelvis

PATIENT CHARACTERISTICS:

- Life expectancy ≥ 6 months

- ECOG performance status 0-2

- WBC ≥ 3,500/µL

- ANC ≥ 1,500/µL

- Platelet count > 100,000/µL

- Hemoglobin > 10 g/dL

- Serum creatinine < 1.5 mg/dL OR creatinine clearance > 50 mL/min

- Total bilirubin normal

- SGOT and/or SGPT normal

- No serious concomitant systemic disorder that, at the discretion of the investigator,
would compromise the safety of the patient or compromise the patient's ability to
complete the study

- No second primary malignancy within the past 5 years except adequately treated in
situ carcinoma (e.g., non-melanomatous carcinoma of the skin) or other malignancy
with no evidence of recurrence

- No active clinically significant infection requiring antibiotics

- No history of coronary artery disease

- No myocardial infarction within the past 6 months

- No sulfa allergy

- No history of gastrointestinal bleeding

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior hormone-ablative treatment

- Prior neoadjuvant hormone-ablative therapy allowed provided it was completed ≥ 3
months ago

- More than 4 weeks since prior herbal products with hormonal activity such as soy, saw
palmetto, or PC-SPES

- No prior or concurrent nonsteroidal anti-inflammatory drug (NSAIDS) for 7 consecutive
days

- No COX-2 inhibitor and/or statin within the past 6 months

- No concurrent warfarin or any other anticoagulant, calcitriol, fibric acid
derivatives, lipid-modifying doses of niacin, or strong cytochrome P450 3A4
inhibitors (e.g., cyclosporine, erythromycin, clarithromycin, and azole antifungals)
or inducers (e.g., St John wort)

- No other concurrent anticancer agents or therapies including chemotherapy, hormonal
therapy, radiotherapy, or experimental therapy