cancer prostate cancer
Conditions
Interventions
Recruited patients will undergo the following procedures:
PET examination with [18F]PSMA-1007
6 months follow-up (collection of all additional diagnostic information
including imaging, as required fo
Sponsors
ABX GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy 2. Suspicion of recurrence or persistence -- after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix) -- after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association) 3. For patients who previously had radical prostatectomy, salvage radiotherapy is one likely treatment plan; for patients who initially underwent radiotherapy (including brachytherapy), confirmation of low volume disease is needed to define (local) treatment. 4. Life expectancy of 6 months or more as judged by the investigator 5. Willing and able to undergo all study procedures 6. Informed consent in writing (dated and signed)
Exclusion criteria
Exclusion criteria: 1. Age: less than18 years 2. Contraindications to any of the ingredients of [18F]PSMA-1007 3. Close affiliation with the investigational site; e.g. first-degree relative of the investigator 4. At the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial 5. Having been previously enrolled in this clinical trial 6. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial 7. Being clinically unstable or requiring emergency treatment 8. Patients who are unwilling to consider a biopsy if clinically recommended 9. Patients who are unable to undergo a PET/CT scan (e.g,, patients who are extremely obese, unable to lie flat or remain still, or have uncontrollable claustrophobia) 10. Patients for whom systemic therapy is the most likely course regardless of PET findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Region-level positive predictive value (PPV) defined as the percentage of all PET-positive regions containing at least one true positive lesion (exactly localized correspondence between [18F]PSMA-1007 PET imaging and the reference standard), regardless of any co-existent false positive findings within the same region, out of all regions containing at least one [18F]PSMA-1007 PET- positive finding. Regions to be considered in the analysis are prostate bed, pelvic lymph nodes, skeleton, and other distant sites (extrapelvic lymph nodes and viscera). • Patient-level *correct detection rate* defined as the percentage of patients who have at least one true PET-positive lesion (exactly localized correspondence between [18F]PSMA-1007 PET imaging and the reference standard), regardless of any co-existent false positive findings, out of all patients who are scanned. | — |
Secondary
| Measure | Time frame |
|---|---|
| • to assess the correct detection rate and PPV of the clinical investigator for [18F]PSMA-1007 for metastatic prostate cancer lesions (patient-based analysis) • to assess detection rate and PPV of [18F]PSMA-1007 by body region for prostate cancer lesions (region-based analysis: prostate bed, pelvic lymph nodes, skeleton, and other distant sites [extrapelvic lymph nodes and viscera]). reads by investigator and 3 independent blinded readers) • to assess the safety profile of [18F]PSMA-1007 | — |
Countries
Netherlands
Outcome results
None listed