Upfront MRI versus a risk calculator for men with suspected prostate cancer
PRORAND - Prostate Risk or Radiology Assessment Non-inferiority Design, a Comparison of Upfront MRI vs Risk Calculator in Men With Suspected Prostate Cancer
NA · Norwegian University of Science and Technology · NCT07422597
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1016 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | Male |
| Sponsor | Norwegian University of Science and Technology (other) |
| Locations | 3 sites (Levanger and 2 other locations) |
| Trial ID | NCT07422597 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Levanger and 2 other locations
- Sykehuset Levanger — Levanger, Norway (NOT_YET_RECRUITING)
- Orkdal sjukehus — Orkanger, Norway (RECRUITING)
- St Olavs Hospital — Trondheim, Norway (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Suspected prostate cancer, Elevated PSA