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

Completed · Phase 3

Conditions studied: Prostate Cancer, Prostate Cancer Recurrent

In brief

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.

Key facts

Study ID

NCT04742361

Run by

ABX advanced biochemical compounds GmbH

People needed

136

Starts

2021-08-27

Expected to finish

2025-05-05

Last updated by the study team

2025-07-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Excel Diagnostics and Nuclear Oncology Center — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• RUMC — Nijmegen, Netherlands
• Inselspital, Universitätsspital — Bern, Switzerland

Full record on ClinicalTrials.gov

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