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
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