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

A Phase IIb Randomised Clinical Trial of the Tolerability, Safety and Efficacy of Adjuvant Docetaxel-Zoledronic Acid After Prostatectomy for High-risk Early Prostate Cancer (AD-ZAP).

Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce relapse in such cases. Patients will be randomized to receive the adjuvant combination therapy or no therapy. All patients will be monitored closely for signs of relapse and treated appropriately with conventional salvage therapy.

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.