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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00258765
Recruitment Status : Terminated (Poor recruitment & not feasible to continue)
First Posted : November 28, 2005
Last Update Posted : April 26, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Zoledronic Acid Drug: Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : May 2006
Primary Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Zoledronic Acid Drug: Zoledronic Acid
Active Comparator: Docetaxel Drug: Docetaxel

Primary Outcome Measures :
  1. safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa [ Time Frame: 6 months after study entry ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00258765

Novartis Investigative Site
Sydney, Australia
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00258765     History of Changes
Other Study ID Numbers: CZOL446GAU15
First Posted: November 28, 2005    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: April 2010

Keywords provided by Novartis:
zoledronic acid
prostate cancer
high risk

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs