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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Zoledronic Acid (Drug); Docetaxel (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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).

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

Primary outcome: safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Novartis Investigative Site, Sydney, Australia
Additional Information

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Starting date: May 2006
Last updated: April 23, 2010

Page last updated: August 23, 2015

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