Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.

Inclusion Criteria:

• Radical prostatectomy for prostate cancer within last 2 months.
• Post-operative Kattan nomogram predicts >25% risk of PSA relapse by 5 years.
• 6-week post-operative serum PSA<0.2ng/mL.
• Low levels of circulating prostate cancer cells in the blood, detected by PCR amplification of PSA mRNA 6 weeks post-prostatectomy.

Exclusion Criteria:

• Pre-operative serum PSA level >20ng/ml.
• Clinical evidence of metastases by 6-week post-operative visit.
• Prior treatment with either ADT or bisphosphonate therapy.
• Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
• Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)

Other protocol defined inclusion / exclusion criteria may apply.