Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ABX advanced biochemical compounds GmbH

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.