Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| European Study of screening for prostate cancer risk calculator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Upfront MRI and Multivariable risk assessment in all men
- description
- Single group
- interventionNames
- Device: European Study of screening for prostate cancer risk calculator
Primary outcomes (1)
- measure
- Detection of clinically significant prostate cancer
- timeFrame
- During the initial diagnostic work-up (up to 6 weeks)
- description
- The study examines whether the risk calculator strategy gives non-inferior detection of csPCa compared with performing an MRI upfront in all men. csPCa defined as International society of Urological pathology grade group (ISUP GG) \>1.
Secondary outcomes (10)
- measure
- Detection of clinically insignificant prostate cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDStraat KRV, Hagens MJ, Cools Paulino Pereira LJ, van den Bergh RCN, Mazel JW, Noordzij MA, Rynja SP. Risk Calculator Strategy Before Magnetic Resonance Imaging Stratification for Biopsy-naive Men with Suspicion for Prostate Cancer: A Cost-effectiveness Analysis. Eur Urol Open Sci. 2024 Oct 14;70:52-57. doi: 10.1016/j.euros.2024.08.017. eCollection 2024 Dec. PMID 39483520
- BACKGROUNDSharp L, Morgan E, Drummond FJ, Gavin A. The psychological impact of prostate biopsy: Prevalence and predictors of procedure-related distress. Psychooncology. 2018 Feb;27(2):500-507. doi: 10.1002/pon.4521. Epub 2017 Oct 11. PMID 28766309
- BACKGROUNDCoyle C, Morgan E, Drummond FJ, Sharp L, Gavin A. Do men regret prostate biopsy: Results from the PiCTure study. BMC Urol. 2017 Jan 26;17(1):11. doi: 10.1186/s12894-016-0194-y. PMID 28125998
- BACKGROUNDReesink DJ, Schilham MGM, van der Hoeven EJRJ, Schoots IG, van Melick HHE, van den Bergh RCN. Comparison of risk-calculator and MRI and consecutive pathways as upfront stratification for prostate biopsy. World J Urol. 2021 Jul;39(7):2453-2461. doi: 10.1007/s00345-020-03488-2. Epub 2020 Oct 22. PMID 33090259
- BACKGROUNDDavik P, Remmers S, Elschot M, Roobol MJ, Bathen TF, Bertilsson H. Reducing prostate biopsies and magnetic resonance imaging with prostate cancer risk stratification. BJUI Compass. 2022 Apr 22;3(5):344-353. doi: 10.1002/bco2.146. eCollection 2022 Sep. PMID 35950035
- BACKGROUNDDavik P, Elschot M, Frost Bathen T, Bertilsson H. Repeat Prostate-specific Antigen Testing Improves Risk-based Selection of Men for Prostate Biopsy After Magnetic Resonance Imaging. Eur Urol Open Sci. 2024 Jun 13;65:21-28. doi: 10.1016/j.euros.2024.05.011. eCollection 2024 Jul. PMID 38974460
- BACKGROUNDPatel HD, Remmers S, Ellis JL, Li EV, Roobol MJ, Fang AM, Davik P, Rais-Bahrami S, Murphy AB, Ross AE, Gupta GN. Comparison of Magnetic Resonance Imaging-Based Risk Calculators to Predict Prostate Cancer Risk. JAMA Netw Open. 2024 Mar 4;7(3):e241516. doi: 10.1001/jamanetworkopen.2024.1516.