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

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Docetaxel; Drug: Zoledronic Acid

• Registration Number: NCT00258765
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-24
• Study First Submitted QC: 2005-11-24
• Study First Posted: 2005-11-28
• Study Start: 2006-05
• Primary Completion: 2006-11
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-23
• Last Update Posted: 2010-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel	Docetaxel	-
Zoledronic Acid	Zoledronic Acid	-

Primary Outcome Measures

Name	Time	Method
safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa	6 months after study entry

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇺 Sydney, Australia