Prostate Cancer Screening With Abbreviated MRI Protocol

NCT05603351 | Unknown

• 1 other identifier: NU22-09-00539
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

magnetic resonance imaging; biparametric MRI; prostate cancer; PI-RADS; PSA; preventive medicine

Outcome Measures

Primary Outcomes (3)

• 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

  Proportion of positive MRI findings (PI-RADS 4+) in the general population of men aged 50-69 years.

  2 years

• Distribution of PI-RADS scores in the observed cohort.

  Distribution of PI-RADS scores (proportion of individual scores 1-5) in the screened population.

  2 years

• Proportion of positive PI-RADS detections in the cohort of patients indicated for biopsy.

  Ratio of significant and non-significant cancers in individual categories of PI-RADS scores in patients indicated for biopsy.

  2 years

Secondary Outcomes (9)

• Feasibility evaluation of a larger-scale study of screening for significant prostate cancer using an imaging modality:

  2 years

• Evaluation of complications after an interventional procedure (biopsy).

  2 years

• Evaluation of patient adherence to preventive examination - active recruitment.

  2 years

• Patient adherence to preventive examination - self-recruitment.

  2 years

• Patient adherence to preventive examination.

  2 years

Study Arms (1)

Preventive prostate examination by bpMRI

EXPERIMENTAL

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.

Diagnostic Test: magnetic resonance; Diagnostic Test: serum PSA examination; Procedure: Biopsy

Interventions

magnetic resonance DIAGNOSTIC_TEST

biparametric MRI with protocol including anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards

Also known as: MRI

Preventive prostate examination by bpMRI

serum PSA examination DIAGNOSTIC_TEST

testing of prostate-specific antigen (PSA) in serum

Preventive prostate examination by bpMRI

Biopsy PROCEDURE

Men with a positive MR test are planned for a targeted MRI/US fusion and systematic prostate biopsy. Men with a positive blood marker (either PSA, PSAD, or PHI) are planned for a systematic 12 core biopsy. Positive test results are PSA ≥ 3, integrated marker PSAD ≥ 0.15, and PHI ≥ 35.

Preventive prostate examination by bpMRI

Eligibility Criteria

• Age: 50 Years - 69 Years
• Gender Eligibility Details: Due to the nature of examined organ (prostate), this study is focused exclusively on men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contraindications to MRI
• Hip replacement
• Known BRCA1/BRCA2 mutation

Sponsors & Collaborators

• Masaryk Memorial Cancer Institute: lead
• Masaryk University: collaborator

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, Czech Republic, 65653, Czechia

RECRUITING

Related Publications (16)

• Loeb 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 BACKGROUND

• Thompson 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 BACKGROUND

• Mottet 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 BACKGROUND

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  PMID: 30824296 BACKGROUND

• Draisma 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.

  PMID: 12813170 BACKGROUND

• Nam RK, Wallis CJ, Stojcic-Bendavid J, Milot L, Sherman C, Sugar L, Haider MA. A Pilot Study to Evaluate the Role of Magnetic Resonance Imaging for Prostate Cancer Screening in the General Population. J Urol. 2016 Aug;196(2):361-6. doi: 10.1016/j.juro.2016.01.114. Epub 2016 Feb 13.

  PMID: 26880413 BACKGROUND

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  PMID: 33570542 BACKGROUND

• van der Leest M, Israel B, Cornel EB, Zamecnik P, Schoots IG, van der Lelij H, Padhani AR, Rovers M, van Oort I, Sedelaar M, Hulsbergen-van de Kaa C, Hannink G, Veltman J, Barentsz J. High Diagnostic Performance of Short Magnetic Resonance Imaging Protocols for Prostate Cancer Detection in Biopsy-naive Men: The Next Step in Magnetic Resonance Imaging Accessibility. Eur Urol. 2019 Nov;76(5):574-581. doi: 10.1016/j.eururo.2019.05.029. Epub 2019 Jun 2.

  PMID: 31167748 BACKGROUND

• Drost FH, Osses D, Nieboer D, Bangma CH, Steyerberg EW, Roobol MJ, Schoots IG. Prostate Magnetic Resonance Imaging, with or Without Magnetic Resonance Imaging-targeted Biopsy, and Systematic Biopsy for Detecting Prostate Cancer: A Cochrane Systematic Review and Meta-analysis. Eur Urol. 2020 Jan;77(1):78-94. doi: 10.1016/j.eururo.2019.06.023. Epub 2019 Jul 18.

  PMID: 31326219 BACKGROUND

• Schoots IG, Padhani AR, Rouviere O, Barentsz JO, Richenberg J. Analysis of Magnetic Resonance Imaging-directed Biopsy Strategies for Changing the Paradigm of Prostate Cancer Diagnosis. Eur Urol Oncol. 2020 Feb;3(1):32-41. doi: 10.1016/j.euo.2019.10.001. Epub 2019 Nov 7.

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• Chiu PK, Ng CF, Semjonow A, Zhu Y, Vincendeau S, Houlgatte A, Lazzeri M, Guazzoni G, Stephan C, Haese A, Bruijne I, Teoh JY, Leung CH, Casale P, Chiang CH, Tan LG, Chiong E, Huang CY, Wu HC, Nieboer D, Ye DW, Bangma CH, Roobol MJ. A Multicentre Evaluation of the Role of the Prostate Health Index (PHI) in Regions with Differing Prevalence of Prostate Cancer: Adjustment of PHI Reference Ranges is Needed for European and Asian Settings. Eur Urol. 2019 Apr;75(4):558-561. doi: 10.1016/j.eururo.2018.10.047. Epub 2018 Nov 2.

  PMID: 30396635 BACKGROUND

• Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.

  PMID: 30898406 BACKGROUND

• de Rooij M, Israel B, Tummers M, Ahmed HU, Barrett T, Giganti F, Hamm B, Logager V, Padhani A, Panebianco V, Puech P, Richenberg J, Rouviere O, Salomon G, Schoots I, Veltman J, Villeirs G, Walz J, Barentsz JO. ESUR/ESUI consensus statements on multi-parametric MRI for the detection of clinically significant prostate cancer: quality requirements for image acquisition, interpretation and radiologists' training. Eur Radiol. 2020 Oct;30(10):5404-5416. doi: 10.1007/s00330-020-06929-z. Epub 2020 May 19.

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  PMID: 31200846 BACKGROUND

• Eldred-Evans D, Tam H, Sokhi H, Padhani AR, Winkler M, Ahmed HU. Rethinking prostate cancer screening: could MRI be an alternative screening test? Nat Rev Urol. 2020 Sep;17(9):526-539. doi: 10.1038/s41585-020-0356-2. Epub 2020 Jul 21.

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• Svetlak M, Standara M, Malatincova T, Stanik M, Miklanek D, Hejcmanova K, Pacal M, Hrabec R, Ngo O, Hejduk K, Kristek J, Uher M, Majek O, Poprach A. Exploring motivations and barriers in prostate cancer screening: lessons from a volunteer-based MRI screening study. Front Public Health. 2025 Nov 17;13:1646494. doi: 10.3389/fpubh.2025.1646494. eCollection 2025.

  PMID: 41334411 DERIVED

Related Links

• Prostate cancer epidemiology in the Czech republic.
• Epidemiology of malignant tumors in the Czech republic

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging; Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michal Staník, MD,PhD.

  Masaryk Memorial Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Standara, MD

CONTACT

00420 543 136 008; standara@mou.cz

Jan Křístek, MD, PhD

CONTACT

00420 605 444 732; jan.kristek@mou.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective cross-sectional (with a longitudinal component, 2nd screening round) study evaluating the possibility of using the abbreviated bpMRI protocol technique for screening clinically significant prostate cancer in men from the general population.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: November 2, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)