FDHT PET/CT for radio-recurrent prostate cancer
- Conditions
- Prostate cancerProstaatkanker
- Registration Number
- NL-OMON21317
- Lead Sponsor
- PI: dr. I.J. de Jong, uroloog. UMCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
A prospective observational imaging pilot study. Only one point of measurement, where one scan will take place.
Study population: 20 men with biochemical recurrent prostate cancer after radiotherapy who are candidates for local salvage treatment.
Exclusion Criteria
-Anti-androgen treatment in the last 6 months
- other malignancies
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - visual assessment of number of lesions en conclusion of re-staging (localized disease, systemic disease or a combination of the two) according to 18 F-FDHT PET/CT on patient-by-patient basis. <br /><br /><br><br>- Semi-quantitative lesion assessment of tracer by measuring and evaluating the maximum and mean standardized uptake value (SUVmax, SUVmean)<br>
- Secondary Outcome Measures
Name Time Method esion-based analysis by comparing the detected lesions in different sites of recurrence/metastases with lesions detected by standard imaging by mMRI and PSMA PET/CT information from follow-up (PSA response to salvage therapy, confirmative biopsy or lymph node dissection and other imaging studies (X-ray, bone scans)). To assess overall accuracy, sensitivity, specificity, PPV and NPV.