Status:
COMPLETED
18F-PSMA-1007 PET Imaging to Detect Primary Prostate Cancer
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ABX advanced biochemical compounds GmbH
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To study the added value of 18F-PSMA-1007 PET to mpMRI in the detection of local prostate cancer lesions.
Detailed Description
Prostate cancer (PCa) is the second most common diagnosed malignancy in males worldwide, with over 1.2 million new patients diagnosed every year. Since the introduction of prostate-specific antigen (P...
Eligibility Criteria
Inclusion
- Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination)
- Males ≥ 18 years
- ECOG 0-1
- Signed informed consent
Exclusion
- Prostate biopsy in the last 6 months
- History of prostate cancer
- Second active malignancy
- Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery)
- Any medical condition that in the opinion of the investigator will affect patients' clinical status when participating in this trial.
- Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04487847
Start Date
September 1 2020
End Date
December 31 2023
Last Update
January 16 2025
Active Locations (1)
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1
Radboud University
Nijmegen, Netherlands