Study Stopped
Poor recruitment \& not feasible to continue
Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.
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).
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2005
CompletedFirst Posted
Study publicly available on registry
November 28, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedApril 26, 2010
April 1, 2010
6 months
November 24, 2005
April 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa
6 months after study entry
Study Arms (2)
Zoledronic Acid
EXPERIMENTALDocetaxel
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Radical prostatectomy for prostate cancer within last 2 months.
- Post-operative Kattan nomogram predicts \>25% risk of PSA relapse by 5 years.
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Sydney, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 24, 2005
First Posted
November 28, 2005
Study Start
May 1, 2006
Primary Completion
November 1, 2006
Last Updated
April 26, 2010
Record last verified: 2010-04