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

ABX-CT-303

This study evaluates the diagnostic performance and safety of \[18F\]PSMA-1007 PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

2021-09-08

2023-06-23

2024-06-01

Active (not recruiting)

Early phase I

136

Inclusion Criteria: * Male with original diagnosis of adenocarcinoma of the prostate with prior definitive therapy * 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) * 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. * Life expectancy of 6 months or more as judged by the investigator * Willing and able to undergo all study procedures * Informed consent in writing Exclusion Criteria: * Age: less than18 years * Contraindications to any of the ingredients of \[18F\]PSMA-1007 * Close affiliation with the investigational site * 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 * Having been previously enrolled in this clinical trial * Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial * Being clinically unstable or requiring emergency treatment * Patients who are unwilling to consider a biopsy if clinically recommended * Patients who are unable to undergo a PET/CT scan * Patients for whom systemic therapy is the most likely course regardless of PET findings.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 136, 'type': 'ACTUAL'}}

2024-01-30