Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer
Phase 4
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00391690
- Lead Sponsor
- Novartis
- Brief Summary
It is the aim of this prospective, single-group, clinical study to assess whether bone parameters can be used as diagnostic tools for early detection of bone metastases in patients with high risk prostate cancer. The usefulness in monitoring zoledronic acid therapy in patients who have developed bone metastases will also be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 99
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method • To assess the relationship between change in bone parameters and bone scan with respect to bone metastases Every 3 months
- Secondary Outcome Measures
Name Time Method Assessment of course of bone parameters (PINP, amino-terminal propeptide of procollagen type 1) and (ICTP, Pyridinoline cross-linked carboxyterminal telopeptide of type I collagen) Every 3 months Assessment of course of Prostate-specific antigen (PSA) Every 3 months Assessment of correlation of bone parameters and PSA Every 3 months Assessment of optimal intervals for bone scans based on serum markers Every 3 months Assessment of time to rise in bone markers PINP and ICTP Every 3 months • Time to detection of bone metastases in bone scan Every 3 months
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Tuebingen, Germany