A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy
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
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.
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
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
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.