Adjuvant Docetaxel-Zoledronic Acid in High-Risk Early Prostate Cancer Following Prostatectomy. - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00258765

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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).

Further study details as provided by Novartis:

Study Start Date:

May 2006

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

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

Locations

Australia

Sydney, Australia

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CZOL446GAU15
Study First Received:	November 24, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00258765
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:

zoledronic acid
prostate cancer
high risk
PSA
docetaxel

Study placed in the following topic categories:

Docetaxel
Diphosphonates
Zoledronic acid
Prostatic Diseases

Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009