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 advanced biochemical compounds GmbH6 sites in 3 countries136 target enrollmentAugust 27, 2021

ConditionsProstate Cancer Prostate Cancer Recurrent

Interventions[18F]PSMA-1007

Overview

Phase: Phase 3
Intervention: [18F]PSMA-1007
Conditions: Prostate Cancer
Sponsor: ABX advanced biochemical compounds GmbH
Enrollment: 136
Locations: 6
Primary Endpoint: Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 27, 2021

End Date

May 5, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

ABX advanced biochemical compounds GmbH

Responsible Party

Sponsor

Eligibility Criteria

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.