A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- Leuprolide Acetate) in Combination With TAXOTERE® (Docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients With Prostate Cancer at High Risk of Relapse After Radical Prostatectomy

Inclusion Criteria:

Participants who met all of the following criteria were considered for enrollment into the
study.

- Pathologically confirmed adenocarcinoma of the prostate based on central pathology
review. All other variants are excluded

- Randomization should occur less than 120 days after prostatectomy AND
lymphadenectomy.

- A predicted probability of 5-year freedom from progression ≤ 60%, as determined by
the postoperative nomogram developed by M. Kattan.

- Bone-scan without evidence of metastasis (within 6 months of randomization)

- Chest x-ray without evidence of metastasis (within 6 months of randomization)

- Abdominal computed tomography (CT) Scan without evidence of metastasis (within 6
months of randomization)

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

- Hematology evaluation within 2 weeks prior to randomization:

- Neutrophils ≥ 2,000/mm3

- Hemoglobin ≥ 10 g/dL

- Platelets ≥ 100,000/mm3

- Hepatic and renal function evaluation within 2 weeks prior to randomization:

- Serum creatinine ≤1.5 × Upper normal limit (UNL) for the institution. If serum
creatinine is > 1.5 × UNL, calculate creatinine clearance (should be ≥
60ml/minute).

- Total serum bilirubin ≤ UNL for the institution. Participants with Gilbert's
syndrome may be eligible if indirect serum bilirubin levels at the time of
randomization and, at least 6 month prior to randomization, confirm this
condition (i.e. elevated indirect serum bilirubin).

- Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic pyruvic
transaminase (SGPT) ≤ 1.5 × institutional UNL if alkaline phosphatase is ≤ UNL
OR

- alkaline phosphatase ≤ 5 × UNL if SGOT and SGPT are ≤ UNL

- Prostate Specific Antigen (PSA) evaluation within 9 months prior to prostatectomy.
However, a 120-day timeframe is recommended

- Post operative PSA necessary for eligibility is defined as a level ≤ 0.2ng/mL using a
standard assay at least 30 days after radical prostatectomy and within 7 days prior
to randomization. Note that randomization should occur within 120 days after radical
prostatectomy

- Serum testosterone ≥ 150ng/dL within 6 months prior to randomization.

Exclusion Criteria:

Participants presenting with any of the following will not be included in the study.

- Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or
any other anticancer therapy.

- Prior radiation therapy.

- Participants who received, are receiving or scheduled to receive post-operative
radiotherapy.

- Participants taking alternative therapies for cancer must stop taking these therapies
prior to randomization. Alternative therapies are not allowed during the treatment or
follow-up portions of the study. This includes (but is not limited to) alternative
therapies such as :

- PC-SPES (all types)

- 5-alpha reductase inhibitors

- Bisphosphonates are to be stopped prior to randomization and are not allowed during
the study.

- Chronic treatment with corticosteroids unless initiated > 6 months prior to study
entry and at low dose ( ≤ 20 mg methylprednisolone per day or equivalent).

- History of a malignancy other than prostate cancer. Exceptions to these criteria
include:

- participants with adequately treated non-melanoma skin cancers, and

- participants with a history of another malignancy that was curatively treated
(including participants with superficial bladder cancer) and who have not had
evidence of disease for a minimum of 5 years.

- Peripheral neuropathy ≥ Grade 2.

- Electrocardiogram (ECG) with significant abnormalities (as determined by the
investigator) within 90 days prior to randomization.

- Participants who are medically unstable, including but not limited to active
infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac
arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled
angina, uncontrolled hypercalcemia, uncompensated congestive heart failure,
uncontrolled diabetes, dementia, seizures, superior vena cava syndrome.

- Participants with history of hypersensitivity to polysorbate 80.

- Participants with a known history of viral hepatitis (B, C).

The above information was not intended to contain all considerations relevant to potential
participation in a clinical trial.