Status:
TERMINATED
Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
30+ years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00258765
Start Date
May 1 2006
Last Update
April 26 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Sydney, Australia