Suspicion of prostate cancer recurrence or persistence after previous definitive treatment, based on American Society for Radiation Oncology (ASTRO) criteria of 3 consecutive PSA rises and/or ASTRO/Phoenix criteria of PSA nadir above 2.0 ng/mL after radiotherapy or cryotherapy and/or greater than 0.2 ng/mL after prostatectomy MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (in
Conditions
Interventions
Product Name: F-18-PSMA-1007
Pharmaceutical Form: Solution for injection
INN or Proposed INN: F-18-PSMA-1007
Current Sponsor code: F-18-PSMA-1007
Other descriptive name: F-18-PSMA-1007
Concentration u
Sponsors
ABX GmbH
Eligibility
Sex/Gender
Male
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
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 |
|---|---|
| Main Objective: To assess, in an independent assessment by 3 blinded readers: 1. the 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). 2. the 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 Objective: 1. to assess the correct detection rate and PPV of the clinical investigator for [18F]PSMA-1007 for metastatic prostate cancer lesions (patient-based analysis) 2. 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) 3. to assess the safety profile of [18F]PSMA-1007 ;Primary end point(s): recurrence rate detected;Timepoint(s) of evaluation of this end point: At the end of the trial, after completion of 6-months clinical follow-up in all patients who complete the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. detection rate of prostate cancer lesions (patient-based: local investigator) 2. per body region: sensitivity and specificity for detection of prostate cancer lesions (local investigators and independent read; expert panel assessment as standard of truth) 3. diagnostic thinking and therapeutic decisions (local investigators and expert panel) 4. appropriateness of therapeutic decisions (expert panel) 5. adverse events / safety 6. Dosimetry estamtes for F-18-PSMA-1007;Timepoint(s) of evaluation of this end point: At the end of the trial, after completion of 6-months clinical follow-up in all patients who complete the study | — |
Countries
Netherlands, Switzerland
Contacts
Public ContactProject Management
pharmtrace klinische Entwicklung GmbH
Outcome results
None listed