PSMA vs. FDHT PET/CT for restaging recurrent prostate cancer
- Conditions
- Biochemical recurrent Prostate Cancer, post-radiotherapy, functional imaging.Biochemisch recidief prostaatkanker, na radiotherapie, functionele beeldvorming
- Registration Number
- NL-OMON23616
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
not applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria
- Active cancer besides prostate cancer
- Suspected metastases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main study parameter/endpoints<br /><br>- Visual assessment of number of lesions en conclusion of re-staging (localized disease, systemic disease or a combination of the two) according to 68 Ga-PMSA PET/CT and 18 F-FDHT PET/CT on patient-by-patient basis. <br /><br>- Semi-quantitative lesion by lesion comparison of tracers by measuring and evaluating the maximum and mean standardized uptake value (SUVmax , SUVmean)
- Secondary Outcome Measures
Name Time Method Secondary study parameters/endpoints <br /><br>Lesion-based analysis by comparing the number of detected lesions in different sites of recurrence/metastases with PSMA PET/CT and also for FDHT PET/CT with lesions detected by mMRI and 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 the overall accuracy, sensitivity, specificity, PPV (positive predictive value) and NPV (negative predictive value) per imaging modality.