Official Title: “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”

To evaluate and compare the efficacy of androgen deprivation with or without Docetaxel as determined by the median progression free survival (PFS) within the period of 18 months of therapy and at least 18 months follow-up.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2012

Intervention(s) in this Clinical Trial

• Drug: Docetaxel
  • Docetaxel 75 mg/m2 q 3 weeks for 10 cycles Eligard 22.5 mg q 3 months x 18 months Bicalutamide 50 mg x 4 weeks
• Drug: Eligard
  • Eligard 22.5 mg q 3 months x 18 months; Bicalutamide 50 mg x 4 weeks;

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm A
  • Docetaxel 75 mg/m2 q 3 weeks for 10 cycles; Eligard 22.5 mg q 3 months x 18 months; Bicalutamide 50 mg x 4 weeks;
• Active Comparator: Arm B
  • Eligard 22.5 mg q 3 months x 18 months; Bicalutamide 50 mg x 4 weeks;

Primary Measures

• Progression-Free Survival (PFS)
  • Time Frame: From randomization to the date of first documentation of PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurs first.
    Safety Issue?: No

Secondary Measures

• Cancer specific survival
  • Safety Issue?: No
• Overall survival
  • Safety Issue?: No
• Patient reported outcomes {FACT-P, multidimensional assessment of fatigue (MAF) scale, Erectile Function Domain of International Index of Erectile Function (EF-IIEF Domain)
  • Safety Issue?: No
• Molecular Markers
  • Safety Issue?: No

• The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Inclusion Criteria:

Subjects must meet all of the following criteria:

• 1. Diagnosis of prostate adenocarcinoma pathologically confirmed.
• 2. History of radical prostatectomy
• 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; concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, immunotherapy, radiotherapy (except salvage radiation therapy), 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.
• 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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Yasir Nagarwala, M.D. Study Director Sanofi-Aventis  

Overall Contact: Public Registry MA US  PublicRegistryUSMA@sanofi-aventis.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00514917

Study ID Number: XRP6976J/3503

ClinicalTrials.gov Identifier: NCT00514917

Health Authority: United States: Institutional Review Board