Application of PET-MR- a diagnostic accuracy study of combined dwMRI and 18F-Choline PET-CT for baseline staging of prostate cancer validated by extended laparoscopic lymph node dissection.
Recruiting
- Conditions
- 100274761001818810038365prostate cancer
- Registration Number
- NL-OMON39287
- Lead Sponsor
- Isala Klinieken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
1. Age 18-80
2. Written informed consent
3. Biopsy proven prostate cancer cT1-T3 Nx M0
4. A chance of more than 15% of having lymph node metastases
Exclusion Criteria
1. Neo-adjuvant treatments for prostate cancer .
2. Severe claustrophobia
3. Any metal prosthesis or device
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Findings of ELND will serve as the reference standard. Analysis of PET-MR and<br /><br>lymph node dissections will be performed both on a per-region and per-patient<br /><br>basis. Patient- and region-based sensitivity and specificity of PET-MR will be<br /><br>calculated. In addition, the complication rate of ELND will be determined after<br /><br>3 months follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In addition, the complication rate of ELND will be determined after 3 months<br /><br>follow-up.</p><br>