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Clinical trial Recruiting at 6 sites Interventional Ages 18 and up Men only

Using repeated MRI and PSA to reduce overdiagnosis and avoid unnecessary prostate biopsies

Official title: Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer

Run by St. Antonius Hospital · NCT07180381 · Data updated 2026-11-12

This approach tests whether regular PSA checks and repeat MRI for men with moderate prostate cancer risk can safely delay biopsies and reduce unnecessary procedures.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment503 (estimated)
SponsorSt. Antonius Hospital
Academic / other
Locations7 sites (Emmen, Drenthe and 6 other locations)
StatusRecruiting
StartedMay 14, 2025
Main results expectedJanuary 2031
Study endsJanuary 2031
Registry record updatedDecember 4, 2025
Trial IDNCT07180381 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men with life expectancy over 10 years, initial PSA under 20 ng/mL, intermediate MRI findings (PI-RADS 3 or PI-RADS 4 with PSAD ≤0.15), no prior prostate biopsy or cancer, and able to undergo repeated MRI are ideal candidates.

Probably not a fit

Men with higher-risk features (for example PI-RADS 5 or PSAD >0.15), prior prostate cancer or biopsy, known pathogenic germline mutations (e.g., BRCA1/2), those on hormonal therapy, or those who cannot have MRIs are unlikely to benefit from this monitoring approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with intermediate-risk findings on MRI (PI-RADS 3 or PI-RADS 4 with PSA density ≤0.15) and PSA <20 ng/mL are followed with scheduled PSA testing and repeat MRI instead of immediate biopsy. Participants are followed for up to four years to see whether clinically significant cancers are detected in time while avoiding unnecessary biopsies. The main safety outcome is how often clinically significant cancers are missed or diagnosed late, and secondary outcomes include the number of biopsies avoided and measures of overtreatment. Men with prior prostate biopsy or cancer, those on hormonal therapy, with known high-risk germline mutations, or unable to undergo MRI are excluded.

Why it matters

Potential benefit: If successful, this approach could spare many men unnecessary biopsies and reduce overdiagnosis and overtreatment while still catching cancers that need treatment.

How similar studies have gone: MRI-guided and active surveillance approaches for low-risk prostate cancer have reduced biopsies and overtreatment, but using PSA plus MRI monitoring specifically in this intermediate-risk group is less well established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

  • Treant
    Emmen, Drenthe, Netherlands     Recruiting
  • Andros Clinics
    Arnhem, Gelderland, Netherlands     Recruiting
  • Radboud University Medical Centre
    Nijmegen, Gelderland, Netherlands     Recruiting
  • Canisius Wilhelmina Hospital
    Nijmegen, Gelderland, Netherlands     Recruiting
  • Antoni van Leeuwenhoek Hospital
    Amsterdam, North Holland, Netherlands     Recruiting
  • St Antonius Hospital
    Nieuwegein, Utrecht, Netherlands     Recruiting
Show 1 more location
  • Maasstad Hospital
    Rotterdam, South Holland, Netherlands     Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464St. Antonius Hospital 22
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.