Phase IIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of MPC-7869 in Delaying the Systemic Progression of Prostate Cancer in Patients With Intermediate to High Risk of Recurrence With Rising PSA Levels After Prostatectomy, Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed localized adenocarcinoma of the prostate (from a
pre-operative core biopsy, surgical specimen, or post-therapy core biopsy)

- Gleason score 5-10 at diagnosis (the highest score is used if multiple scores are
available)

- Must have undergone 1 of the following curative treatment strategies:

- Radical prostatectomy

- Not a candidate for radiotherapy

- Radical prostatectomy followed by radiotherapy at the time of surgery or any
time thereafter

- Radiotherapy of the prostate and/or surrounding structures by external beam
radiotherapy (EBRT), brachytherapy (BT), or a combination of EBRT and BT

- Must have 3 consecutive rising prostate-specific antigen (PSA) measurements OR meets
slope criteria

- Biochemical failure, meeting 1 of the following criteria:

- PSA at least 0.2 ng/mL post radical prostatectomy

- PSA greater than 1.5 ng/mL after radiotherapy or appropriate calculated slope

- Testosterone at least 100 ng/mL

- No rise in PSA with concurrent clinically active prostatitis

- No metastatic prostate cancer

- PSA no greater than 20.0 ng/mL

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- WBC at least 2,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- AST or ALT no greater than 2 times upper limit of normal

Renal

- Creatinine no greater than 2.0 mg/dL

Cardiovascular

- No uncontrolled cardiac conditions

- No New York Heart Association class III or IV heart disease

Gastrointestinal

- No active ulcer disease diagnosed within the past 3 months

- No upper gastrointestinal bleed requiring a transfusion within the past 3 years

- No non-steroidal anti-inflammatory drug (NSAID)-associated ulcers within the past 5
years

Other

- No known hypersensitivity to NSAIDs, including COX-2-specific inhibitors (e.g.,
celecoxib or rofecoxib)

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer

- No active systemic infections

- No other serious uncontrolled medical condition

- No dementia or altered mental status

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent biologic therapy

Chemotherapy

- More than 5 years since prior cytotoxic chemotherapy for other malignant disease

- No prior cytotoxic chemotherapy for prostate cancer

- No concurrent chemotherapy

Endocrine therapy

- More than 9 months since prior androgen-deprivation therapy other than as
cytoreductive therapy (neoadjuvantly or adjuvantly for less than 9 months) with the
intent to cure

- More than 3 months since prior cyproterone, finasteride, diethylstilbestrol,
megestrol, or other hormonally active (antiandrogen or antiprostate) therapies

Radiotherapy

- See Disease Characteristics

- No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other
radioisotope materials for palliative intent or metastasis intervention

- Concurrent iodine I 125 or palladium Pd 103 for primary brachytherapy with curative
intent allowed

Surgery

- See Disease Characteristics

- More than 8 weeks since prior major surgery and recovered

- No prior orchiectomy

Other

- More than 1 month since prior PC-SPES

- More than 1 month since prior investigational agents or devices (6 months for other
investigational therapy for prostate cancer)

- No prior bisphosphonates (e.g., pamidronate, alendronate, or clodronate) for
palliative intent or metastasis intervention

- At least 2 months since prior chronic non-steroidal anti-inflammatory drugs (NSAIDs),
including cyclooxygenase-2 (COX-2)-specific inhibitors (e.g., celecoxib or
rofecoxib), administered for more than 7 days per month

- No concurrent CYP2C9 inhibitor or substrates, including but not limited to the
following:

- Phenytoin

- Fluvastatin

- Amiodarone

- Fluconazole

- Acenocoumarol

- Diclofenac

- No concurrent ketoconazole

- No concurrent antiretroviral therapy for HIV-positive patients

- Concurrent cardioprotective aspirin up to 100 mg once daily allowed