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

This study has been terminated.
(Poor recruitment & not feasible to continue)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00258765
First received: November 24, 2005
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Zoledronic Acid
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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).

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa [ Time Frame: 6 months after study entry ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: May 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic Acid Drug: Zoledronic Acid
Active Comparator: Docetaxel Drug: Docetaxel

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258765

Locations
Australia
Novartis Investigative Site
Sydney, Australia
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00258765     History of Changes
Other Study ID Numbers: CZOL446GAU15
Study First Received: November 24, 2005
Last Updated: April 23, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:
zoledronic acid
prostate cancer
high risk
PSA
docetaxel

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Zoledronic acid
Diphosphonates
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014