Phase III study of [18F]PSMA-1007 positron emission tomography for the detection of prostate cancer lesions in patients with biochemical recurrence after previous definitive treatment for localized prostate cancer
- Conditions
- cancerprostate cancer10038597
- Registration Number
- NL-OMON52213
- Lead Sponsor
- ABX GmbH
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 41
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Region-level positive predictive value (PPV) defined as the percentage of all<br /><br>PET-positive regions containing at least one true positive lesion (exactly<br /><br>localized correspondence between [18F]PSMA-1007 PET imaging and the reference<br /><br>standard), regardless of any co-existent false positive findings within the<br /><br>same region, out of all regions containing at least one [18F]PSMA-1007 PET-<br /><br>positive finding. Regions to be considered in the analysis are prostate bed,<br /><br>pelvic lymph nodes, skeleton, and other distant sites (extrapelvic lymph nodes<br /><br>and viscera).<br /><br>• Patient-level *correct detection rate* defined as the percentage of patients<br /><br>who have at least one true PET-positive lesion (exactly localized<br /><br>correspondence between [18F]PSMA-1007 PET imaging and the reference standard),<br /><br>regardless of any co-existent false positive findings, out of all patients who<br /><br>are scanned.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• to assess the correct detection rate and PPV of the clinical investigator for<br /><br>[18F]PSMA-1007 for metastatic prostate cancer lesions (patient-based analysis)<br /><br>• to assess detection rate and PPV of [18F]PSMA-1007 by body region for<br /><br>prostate cancer lesions (region-based analysis: prostate bed, pelvic lymph<br /><br>nodes, skeleton, and other distant sites [extrapelvic lymph nodes and<br /><br>viscera]). reads by investigator and 3 independent blinded readers)<br /><br>• to assess the safety profile of [18F]PSMA-1007</p><br>