ZEUS study.
Completed
- Conditions
- Patients with high risk prostate cancer.
- Registration Number
- NL-OMON23035
- Lead Sponsor
- European Association of Urology
- Brief Summary
Wirth et al. Prevention of bone metastases in patients with high-risk non metastatic prostate cancer treated with Zoledronic Acid: Efficacy and safety results of the Zometa EUropean Study (ZEUS). Eur. Urol. 67 (2015) 482–491. http://dx.doi.org/10.1016/j.eururo.2014.02.014
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1300
Inclusion Criteria
1. Male patients aged 18+, ECOG = 0 (Karnofsky performance status > 90);
2. M0 prostate cancer patients who previously received local curative treatment (e.g. surgery, radiotherapy) or no local curative treatment. Duration between local curative treatment and starting of the study drug must not be longer than 6 months;
Exclusion Criteria
1. Patients with known visceral metastasis or bone metastases in bone scan;
2. Prior treatment with bisposphonates;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter is the proportion of patients who develop bone metastases during the study.
- Secondary Outcome Measures
Name Time Method 1. Time to first bone metastasis; <br /><br>2. Overall survival; <br /><br>3. Time to PSA doubling; <br /><br>4. Safety; <br /><br>5. On bone mineral density (sub study in selected centres) and <br /><br>6. On biochemical markers of bone turnover (sub study in selected centers only).