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Clinical trial Recruiting at 2 sites Interventional Ages 50 to 75 Men only

Upfront MRI versus a risk calculator for men with suspected prostate cancer

Official title: PRORAND - Prostate Risk or Radiology Assessment Non-inferiority Design, a Comparison of Upfront MRI vs Risk Calculator in Men With Suspected Prostate Cancer

Run by Norwegian University of Science and Technology · NCT07422597 · Data updated 2026-11-12

This trial tries to see if using a risk calculator instead of giving every man an upfront prostate MRI can safely reduce unnecessary MRIs and biopsies for men with suspected prostate cancer and PSA between 3 and 20 ng/ml.

More Prostate Cancer trials

Quick facts

Study typeInterventional
Ages50 Years to 75 Years
SexMen only
Enrollment1016 (estimated)
SponsorNorwegian University of Science and Technology
Academic / other
Locations3 sites (Levanger and 2 other locations)
StatusRecruiting
StartedMarch 1, 2026
Main results expectedDecember 31, 2027
Study endsDecember 31, 2029
Registry record updatedOctober 21, 2026
Trial IDNCT07422597 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men with suspected localized prostate cancer who have PSA 3–20 ng/ml, a suspicious DRE (cT2), more than 10 years expected life, no prior prostate cancer, and no contraindication to MRI or biopsy are the intended participants.

Probably not a fit

Men with more advanced disease (cT3/cT4), PSA over 20 ng/ml, prior prostate cancer, contraindications to MRI or biopsy, or on medications that affect PSA are unlikely to benefit from this pathway.

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

What this trial studies

Many men with an elevated PSA undergo prostate MRI and biopsy, but PSA has low specificity and leads to overdiagnosis of indolent cancers. This non-inferiority trial randomizes men with suspected localized prostate cancer (PSA 3–20 ng/ml, suspicious DRE, >10 years expected life) to either upfront MRI or a pathway guided by a multivariable European risk calculator. In the calculator arm, imaging and biopsy are performed only if the calculated risk crosses predefined thresholds, and outcomes include detection of clinically significant prostate cancer, numbers of MRIs and biopsies, and rates of overdiagnosis. The trial aims to determine whether the calculator strategy can maintain detection of dangerous cancers while reducing unnecessary procedures and related patient anxiety.

Why it matters

Potential benefit: If successful, this approach could maintain detection of clinically significant prostate cancer while reducing the number of MRIs and biopsies, lowering overdiagnosis and patient anxiety.

How similar studies have gone: Previous trials have shown MRI-first pathways reduce unnecessary biopsies and that risk calculators can help stratify biopsy need, but direct non-inferiority comparisons of a calculator-driven pathway against universal upfront MRI are less established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* more than 10 years remaining life expectancy
* Suspected localized prostate cancer
* Suspicious DRE (cT2)
* PSA 3-20 ng/ml

Exclusion Criteria:

* cT3 and/or cT4 (on DRE)
* PSA \>20 ng/ml
* Prior diagnosis of prostate cancer
* Contraindications to MRI or to prostate biopsy
* Medications known to affect serum PSA levels

Where it's running

  • Orkdal sjukehus
    Orkanger, Norway     Recruiting
  • St Olavs Hospital
    Trondheim, Norway     Recruiting
  • Sykehuset Levanger
    Levanger, Norway     Not yet recruiting

Study contacts

  • Principal investigator: Petter Davik, MD, PhD — Norwegian University of Science and Technology (NTNU)
  • Study coordinator: Petter Davik, MD, PhD
  • Email: petter.davik@ntnu.no
  • Phone: +47 72829919

Similar studies

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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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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.