A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA

Inclusion Criteria:

Subjects must meet all of the following criteria:

1. Diagnosis of prostate adenocarcinoma pathologically confirmed.
2. History of radical prostatectomy (pre-operative radiation therapy to the prostate or pelvis or salvage radiation after radical prostatectomy is allowed).
3. Demonstration of biochemical progression of disease based on PSA doubling time. The minimum PSA value for eligibility will be greater than or equal to 1. PSA doubling time over three values must be less than or equal to 9 months with a minimum of 3 weeks between assessments. PSA doubling time calculation must start at a minimum value of 0.2 (see Section 13.2). Subjects in this group may have no radiographic findings that are suspicious for metastatic disease.
4. Serum testosterone greater than or equal to 100 ng/dl.
5. Karnofsky performance status (KPS) greater than or equal to 70%.

6. Adequate organ function as defined by the following laboratory criteria:

   • WBC greater than or equal to 3500/mm3
   • ANC greater than or equal to 1500/mm3
   • Platelet count greater than or equal to 100,000/mm3
   • Hemoglobin greater than or equal to 10.0 g/dl
   • Total Bilirubin less than or equal to ULN unless due to Gilbert's disease
   • Creatinine less than or equal to1.5 mg/dl or creatinine clearance of greater than or equal to 60 cc/min

   AST and ALT and Alkaline Phosphatase must be within the range as indicated below. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.

7. Previous hormonal therapy is allowed provided that the total duration of therapy does not exceed 6 months.
8. Male subjects must be at least 18 years of age.
9. Subjects must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
10. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
11. Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
2. Uncontrolled serious active infection.
3. Anticipated duration of life of less than 2 years
4. Less than 5-year history of successful treatment for other cancers or concurrent active nonprostate cancer other than nonmelanoma skin tumor.
5. Peripheral neuropathy greater than or equal to Grade 2.
6. History of hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80, leuprolide, or bicalutamide.
7. Prior chemotherapy within the past 10 years (except non-taxane based chemotherapy for treatment of other cancers); concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, immunotherapy, radiotherapy (except pre-operative radiation or salvage radiation therapy after prostatectomy), chemoembolization therapy, cryotherapy.
8. Other severe acute or chronic medical conditions including psychiatric disease(s), or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety, delay or prohibit protocol participation, or interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
9. Radiographic findings suspicious for metastatic disease in the treating physician's clinical judgment. Patients who had radiographically suspicious pelvic lymph nodes prior to radial prostatectomy, but who, at the time of registration to the trial doe not have suspicious adenopathy (for example, either because those nodes were resected or were irradiated post-operative are eligible. Patients are eligible even if they had tumor-containing pelvic adenopathy at the time of surgery as long as at the time of registration they do not have radiographically evident nodal disease in the clinician's opinion.
10. Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
11. Subject unlikely to comply with protocol or research tests, eg, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
12. Subject who participated in another clinical study/ received investigational product within 30 days of screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.