Clinical trial · Interventional
Prostate Cancer Screening With Abbreviated MRI Protocol
ProstaPilot: Prostate Cancer Screening Using MRI With an Abbreviated Protocol
- 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)
Prostate cancer is one of the most common malignancies in the male population with incidence and mortality rates comparable to breast cancer in women, but in contrast, a population screening program that would fulfill all the recommended criteria is not yet available. According to international recommendations, the preventive PSA sampling used in clinical practice is not suitable because of the concurrent detection of clinically insignificant carcinomas in a major proportion of tests. These clinically non-significant cancers make up a significant and increasing proportion with age. Detection of non-significant cancers burdens the health care system and patients with the care that has no positive impact on their health. Current preventive serum prostate-specific antigen (PSA) testing does not distinguish benign hyperplasia and nonsignificant carcinoma from clinically significant cancer. It is therefore not suitable for full-scale screening. According to current guidelines, magnetic resonance imaging (MRI) is indicated only in patients with an increased risk of cancer for detection or staging after biopsy and is not used for screening. According to recent studies, MRI has detected an increased proportion of significant cancers in the general population compared to screening based on PSA, while fewer clinically insignificant cancers have been detected. In screening, a shorter examination protocol without contrast medium (biparametric MRI) is used with a lower cost per examination, allowing to increase both the number of patients examined and patient comfort. The main objective of the project is to assess the contribution of imaging in the screening of clinically significant prostate cancer and to validate the published results in the Czech population, and extend the screening model by the second round of examinations and additional laboratory markers. The secondary aim is to design a subsequent study with a larger number of participants allowing statistical evaluation, similar to the successful breast cancer screening.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| magnetic resonance | Diagnostic Test | — | UNRESOLVED |
| serum PSA examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preventive prostate examination by bpMRI
- description
- The cohort consists of patients: * with age 50-69 years * without any contraindications to MRI or biopsy * without known status of prostate cancer or prostate biopsy in the past (interventions for BPH are not a restriction) * without known BRCA mutation * without PSA test or prostate MRI in the past 2 years * without any signs of prostatitis or urinary tract infection in the past 6 months.
- interventionNames
- Diagnostic Test: magnetic resonance
- Diagnostic Test: serum PSA examination
- Procedure: Biopsy
Primary outcomes (3)
- measure
- Assessment of the importance of the imaging test in the screening of significant prostate cancer in asymptomatic men, compared with PSA screening: Proportion of positive MRI findings
- timeFrame
- 2 years
- description
- Proportion of positive MRI findings (PI-RADS 4+) in the general population of men aged 50-69 years.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Age 50-69 years * Life expectancy over 10 years * Ability to undergo all planned procedures (without contraindications to MRI or biopsy) * No known prostate cancer or prostate biopsy in the past (interventions for BPH are not a restriction) * No PSA test or prostate MRI in the past 2 years. * No signs of prostatitis or urinary tract infection in the past 6 months. * Signed informed consent. Exclusion Criteria: * Contraindications to MRI * Hip replacement * Known BRCA1/BRCA2 mutation
References
Publications (16)
- BACKGROUNDLoeb S, Bjurlin MA, Nicholson J, Tammela TL, Penson DF, Carter HB, Carroll P, Etzioni R. Overdiagnosis and overtreatment of prostate cancer. Eur Urol. 2014 Jun;65(6):1046-55. doi: 10.1016/j.eururo.2013.12.062. Epub 2014 Jan 9. PMID 24439788
- BACKGROUNDThompson IM, Pauler DK, Goodman PJ, Tangen CM, Lucia MS, Parnes HL, Minasian LM, Ford LG, Lippman SM, Crawford ED, Crowley JJ, Coltman CA Jr. Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med. 2004 May 27;350(22):2239-46. doi: 10.1056/NEJMoa031918. PMID 15163773
- BACKGROUNDMottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7. PMID 33172724
- BACKGROUNDHugosson J, Roobol MJ, Mansson M, Tammela TLJ, Zappa M, Nelen V, Kwiatkowski M, Lujan M, Carlsson SV, Talala KM, Lilja H, Denis LJ, Recker F, Paez A, Puliti D, Villers A, Rebillard X, Kilpelainen TP, Stenman UH, Godtman RA, Stinesen Kollberg K, Moss SM, Kujala P, Taari K, Huber A, van der Kwast T, Heijnsdijk EA, Bangma C, De Koning HJ, Schroder FH, Auvinen A; ERSPC investigators. A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer. Eur Urol. 2019 Jul;76(1):43-51. doi: 10.1016/j.eururo.2019.02.009. Epub 2019 Feb 26. PMID 30824296
- BACKGROUNDDraisma G, Boer R, Otto SJ, van der Cruijsen IW, Damhuis RA, Schroder FH, de Koning HJ. Lead times and overdetection due to prostate-specific antigen screening: estimates from the European Randomized Study of Screening for Prostate Cancer. J Natl Cancer Inst. 2003 Jun 18;95(12):868-78. doi: 10.1093/jnci/95.12.868.