Monitoring men at moderate risk of prostate cancer with PSA and MRI
Tests PSA and MRI monitoring instead of immediate biopsy for suspected prostate cancer.
Plain-language title generated from the registry record
Registry title: Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Key facts
- Where
- Amsterdam, Arnhem, Emmen, Nieuwegein, Nijmegen, and Rotterdam, NetherlandsSee the 7 sites
Where in Netherlands
- Antoni van Leeuwenhoek HospitalAmsterdam, NetherlandsTaking people
- Andros ClinicsArnhem, NetherlandsTaking people
- TreantEmmen, NetherlandsTaking people
- St. Antonius HospitalNieuwegein, NetherlandsTaking people
- Canisius-Wilhelmina HospitalNijmegen, NetherlandsTaking people
- Radboud university medical centreNijmegen, NetherlandsTaking people
- Maasstad HospitalRotterdam, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Antonius Hospital
- Trial code
- NCT07180381
- Record updated
- 4 December 2025
- Original description
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 PSA and MRI instead of immediate biopsy,.Read full original descriptionShow less
Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
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 PSA and MRI instead of immediate biopsy,.
The main questions it aims to answer are:
* Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed? * Does it reduce unnecessary biopsies and overtreatment?
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; 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); Proven germline mutation for PCa (for example: BRCA1; BRCA2).