Pilot study: clinical evaluation of biomarkers as predictors of survival in castrate-resistant prostate cancer patients.
Recruiting
- Conditions
- Castrate-Resistant Prostate Cancer (CRPC)1003859710036958
- Registration Number
- NL-OMON34838
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Histologically confirmed prostate cancer
2. Either biological recurrence (2 consecutive increases in the PSA level after the nadir, with a
minimum 2 week interval between measurements) and/or radiological recurrence (new
osseous lesions and/or new or enlarged soft tissue metastases)
3. Testosterone <50 ng/mL
4. PSA >5 ng/mL
5. ECOG performance status of 0-2
6. Starting first course docetaxel-based chemotherapy treatment
Exclusion Criteria
Within 4 wk of entry use of an antiandrogen (6wk for nilutamide and bicalutamide).
Within 30 days of entry radiation or radionuclide therapy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study will be Overall Survival (OS). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint of this study will be biochemical and/or radiological<br /><br>recurrence of disease.</p><br>