Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

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.