Status:
RECRUITING
Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Lead Sponsor:
St. Antonius Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using...
Eligibility Criteria
Inclusion
- Life expectancy \> 10 years
- initial PSA \< 20 ng/ml
- No signs of extracapsular disease on digital rectal examination
- Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =\< 0.15
- Mentally competent and able to comprehend the potential benefits and burdens of the study
- Willing to undergo the follow-up protocol for a maximum of four years
- written and signed informed consent
Exclusion
- Men who have previously undergone a prostate biopsy
- Men who have a prior PCa diagnosis
- using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors
- Proven germline mutation for PCa (for example: BRCA1; BRCA2)
- Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion.
- severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)
Key Trial Info
Start Date :
May 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2031
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT07180381
Start Date
May 14 2025
End Date
January 1 2031
Last Update
December 4 2025
Active Locations (7)
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1
Treant
Emmen, Drenthe, Netherlands, 7824AA
2
Andros Clinics
Arnhem, Gelderland, Netherlands, 6842 CV
3
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands, 6525 GA
4
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands