NCT07180381Recruiting
Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 503 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- May 2025
- Primary completion date
- Jan 2031
- Lead sponsor
- St. Antonius Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07180381
What you commit to
- Study type: Interventional
- Planned participants: 503
- From May 2025 to the primary completion date, Jan 2031
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)
Other
- Proven germline mutation for PCa (for example: BRCA1; BRCA2)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antoni van Leeuwenhoek Hospital Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Andros Clinics Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Treant Coordinator of this site? Confirm its status | Emmen | Netherlands | Recruiting |
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Radboud university medical centre Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Canisius-Wilhelmina Hospital Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Maasstad Hospital Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.