RecruitingNot ApplicableNCT07422597

Prostate Risk Or Radiology Assessment Non-inferiority Design, Upfront MRI or Risk Calculator in 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


Sponsor

Norwegian University of Science and Technology

Enrollment

1,016 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Thousands of men take a PSA test to investigate whether they have prostate cancer every year. For the vast majority, the test is normal and further investigations are not necessary. In others, the test is sufficiently elevated that men are referred for further investigations. Most men with an elevated PSA are offered an MRI examination of the prostate gland, and for some, a tissue sample of the prostate is also recommended if the suspicion of cancer is high enough. Although this comprehensive investigation reveals most clinically significant , or dangerous cases of cancer, many indolent, or "harmless" cancer cases are also detected, which would not have caused the man any harm during his lifetime (approximately 20% of all prostate cancer diagnoses diagnosed in current clinical practive). Cancer treatment is not recommended for such cases, but for many men, the diagnosis and subsequent follow-up can cause him and his family anxity and concern. In addition, prostate biopsies are unpleasant for the patient and the investigation process is resource-intensive for both the man and the health care service. Risk stratification uses machine learning methods to better identify the men who require further investigations with MRI and tissue samples. In this project, the investigators investigate whether the best risk stratification tools are non-inferior in detecting clinically significant prostate cancer compared to current practice, and whether they lead to fewer tissue samples, MRI scans, less health anxiety, and better cost-effectiveness.


Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 75 Years

Inclusion Criteria4

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

Exclusion Criteria5

  • 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

Interventions

DEVICEEuropean Study of screening for prostate cancer risk calculator

The ERSPC RCs are the currently best known and most utilised multivariable PCa risk stratification tools. All participating men undergo risk stratification by ERSPC RCs to determine need for MRI and for biopsy.


Locations(3)

Sykehuset Levanger

Levanger, Norway

Orkdal sjukehus

Orkanger, Norway

St Olavs Hospital

Trondheim, Norway

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NCT07422597


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