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

Prostate Cancer Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00258765
• Other study ID #: CZOL446GAU15
• Status: Terminated
• Phase: Phase 2
• First received: November 24, 2005
• Last updated: April 23, 2010
• Start date: May 2006

Study information

• Verified date: April 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic Acid

• Docetaxel

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa		6 months after study entry	No