Status:
COMPLETED
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
Lead Sponsor:
ABX advanced biochemical compounds GmbH
Conditions:
Prostate Cancer
Prostate Cancer Recurrent
Eligibility:
MALE
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2025
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04742361
Start Date
August 27 2021
End Date
May 5 2025
Last Update
July 15 2025
Active Locations (6)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042
4
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112