Prostate CancerProstaPilotNCT05603351
Prostate Cancer Screening With Abbreviated MRI Protocol
A study testing magnetic resonance, serum PSA examination and Biopsy in people with Prostate Cancer, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- magnetic resonance, serum PSA examination and Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications to MRI
- Hip replacement
- Known BRCA1/BRCA2 mutation
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, Czech Republic, 65653
Michal Standara, MD, +420543136008, standara@mou.cz
Jan Kristek, Ph.D., MD, +420605444732, jan.kristek@mou.cz
About this study
Official title: ProstaPilot: Prostate Cancer Screening Using MRI With an Abbreviated Protocol
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.
Read the detailed description
A prospective cross-sectional (with a longitudinal component, 2nd screening round) study evaluating the possibility of using the biparametric MRI protocol technique for screening clinically significant prostate cancer in men from the general population.
Tests performed:
- Serum PSA
- PHI calculation (Prostate Health Index) to be performed only if the PSA values are in the range of 2-10 ng/l
- MRI of the prostate (abbreviated biparametric protocol)
- Digital rectal examination (DRE) as part of a clinical visit at a urologist in patients with a positive PSA test
- Biopsy - if indicated
MRI specifications:
- Protocol with anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards
- Typical complete examination time does not exceed 20 minutes, planned acquisition time less than 15 minutes.
- No contrast agent or spasmolytics is injected.
Blinding:
- Every test evaluator (radiologist/urologist) does not know the results of other tests. · MRI reports entered in the registry obligatorily before the biopsy.
- The patient is not informed which test was positive and resulted in an indication for biopsy.
- The pathologist does not know the results of MRI or laboratory tests.
The sequence of tests:
The MRI is assessed with the PI-RADS 2.1 system, each finding is reported on a scale of 1-5. To minimize the detection of non-significant cancers and to reduce the number of biopsies according to the results of the IP1-Prostagram study, a PI-RADS value of 4-5 was chosen as a positive test representation.
Consensual double reading by 2 experienced uroradiologists (at least 400 MRI of the prostate read by the beginning of the study). Men with a positive MRI 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.
Study participants are invited to repeat the screening tests after 2 years by letter. If they do not respond to a written offer, also by e-mail and SMS.
Definition of clinically significant cancer: • ISUP Grade Group ≥ 2.
- Conditions
- Prostate Cancer
- Being tested
- magnetic resonance, serum PSA examination, Biopsy
- Keywords
- magnetic resonance imaging, biparametric MRI, prostate cancer, PI-RADS, PSA, preventive medicine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonanceDiagnostic test
Also called MRI
biparametric MRI with protocol including anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards
serum PSA examinationDiagnostic test
testing of prostate-specific antigen (PSA) in serum
BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: magnetic resonance; Diagnostic Test: serum PSA examination; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (9)
Feasibility evaluation of a larger-scale study of screening for significant prostate cancer using an imaging modality:
Concordance rate (%) between radiologists performing MRI scoring.
Measured: 2 years
Evaluation of complications after an interventional procedure (biopsy).
Number of complications after biopsy.
Measured: 2 years
Evaluation of patient adherence to preventive examination - active recruitment.
Number of participants who agreed to be included in the study through used recruitment strategies.
Measured: 2 years
Patient adherence to preventive examination - self-recruitment.
Number of participants who contacted the team themselves with a request for testing.
Measured: 2 years
Patient adherence to preventive examination.
Number of participants who signed the informed consent and were enrolled in the study.
Measured: 2 years
Evaluation of patient adherence to preventive examination.
Number of participants who visited a screening facility.
Measured: 2 years
Evaluation of patient adherence to preventive examination - completation of planned exams.
Number of participants who completed the designated examination.
Measured: 2 years
Evaluation of the financial burden of the study for the future preventive program of prostate cancer screening.
Costs of individual inclusion and screening tests.
Measured: 2 years
Detection and assessment of potential barriers to patient participation in the study. Assessment of patient adherence to remain in the study throughout the study period.
Numbers and reasons of participants who did not complete scheduled tests, follow-up examinations, or withdrew informed consent.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 May 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor
- Investigators
- Michal Staník, MD,PhD., Principal investigator, Masaryk Memorial Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603351
- Sponsor's protocol ID
- NU22-09-00539
- Acronym
- ProstaPilot
- Status last verified
- Oct 2022
- First submitted
- 2 Sep 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24439788Thompson 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.
PubMed 15163773Mottet 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.
PubMed 33172724Hugosson 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.
PubMed 30824296Draisma 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.
PubMed 12813170Nam 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.
PubMed 26880413Eldred-Evans D, Burak P, Connor MJ, Day E, Evans M, Fiorentino F, Gammon M, Hosking-Jervis F, Klimowska-Nassar N, McGuire W, Padhani AR, Prevost AT, Price D, Sokhi H, Tam H, Winkler M, Ahmed HU. Population-Based Prostate Cancer Screening With Magnetic Resonance Imaging or Ultrasonography: The IP1-PROSTAGRAM Study. JAMA Oncol. 2021 Mar 1;7(3):395-402. doi: 10.1001/jamaoncol.2020.7456.
PubMed 33570542van 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.
PubMed 31167748Drost 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.
PubMed 31326219Schoots 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.
PubMed 31706946Chiu 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.
PubMed 30396635Turkbey 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.
PubMed 30898406de 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.
PubMed 32424596Boesen L, Norgaard N, Logager V, Balslev I, Bisbjerg R, Thestrup KC, Jakobsen H, Thomsen HS. Prebiopsy Biparametric Magnetic Resonance Imaging Combined with Prostate-specific Antigen Density in Detecting and Ruling out Gleason 7-10 Prostate Cancer in Biopsy-naive Men. Eur Urol Oncol. 2019 May;2(3):311-319. doi: 10.1016/j.euo.2018.09.001. Epub 2018 Sep 27.
PubMed 31200846Eldred-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.
PubMed 32694594
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProstaPilot: Prostate Cancer Screening Using MRI With an Abbreviated Protocol
- ClinicalTrials.gov ID
- NCT05603351
- Acronym / sponsor ID
- ProstaPilot / NU22-09-00539
- Conditions
- Prostate Cancer
- Keywords
- magnetic resonance imaging, biparametric MRI, prostate cancer, PI-RADS, PSA, preventive medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective cross-sectional (with a longitudinal component, 2nd screening round) study evaluating the possibility of using the biparametric MRI protocol technique for screening clinically significant prostate cancer in men from the general population.
Tests performed:
- Serum PSA
- PHI calculation (Prostate Health Index) to be performed only if the PSA values are in the range of 2-10 ng/l
- MRI of the prostate (abbreviated biparametric protocol)
- Digital rectal examination (DRE) as part of a clinical visit at a urologist in patients with a positive PSA test
- Biopsy - if indicated
MRI specifications:
- Protocol with anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards
- Typical complete examination time does not exceed 20 minutes, planned acquisition time less than 15 minutes.
- No contrast agent or spasmolytics is injected.
Blinding:
- Every test evaluator (radiologist/urologist) does not know the results of other tests. · MRI reports entered in the registry obligatorily before the biopsy.
- The patient is not informed which test was positive and resulted in an indication for biopsy.
- The pathologist does not know the results of MRI or laboratory tests.
The sequence of tests:
The MRI is assessed with the PI-RADS 2.1 system, each finding is reported on a scale of 1-5. To minimize the detection of non-significant cancers and to reduce the number of biopsies according to the results of the IP1-Prostagram study, a PI-RADS value of 4-5 was chosen as a positive test representation.
Consensual double reading by 2 experienced uroradiologists (at least 400 MRI of the prostate read by the beginning of the study). Men with a positive MRI 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.
Study participants are invited to repeat the screening tests after 2 years by letter. If they do not respond to a written offer, also by e-mail and SMS.
Definition of clinically significant cancer: • ISUP Grade Group ≥ 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preventive prostate examination by bpMRI | Experimental | Diagnostic Test: magnetic resonance, Diagnostic Test: serum PSA examination, Procedure: BiopsyThe 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. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Contraindications to MRI
- Hip replacement
- Known BRCA1/BRCA2 mutation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonanceAlso: MRIbiparametric MRI with protocol including anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards | Diagnostic test | Preventive prostate examination by bpMRI |
| serum PSA examinationtesting of prostate-specific antigen (PSA) in serum | Diagnostic test | Preventive prostate examination by bpMRI |
| BiopsyMen 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. | Procedure or surgery | Preventive prostate examination by bpMRI |
Primary outcome
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
Time frame: 2 years
Proportion of positive MRI findings (PI-RADS 4+) in the general population of men aged 50-69 years.
Distribution of PI-RADS scores in the observed cohort.
Time frame: 2 years
Distribution of PI-RADS scores (proportion of individual scores 1-5) in the screened population.
Proportion of positive PI-RADS detections in the cohort of patients indicated for biopsy.
Time frame: 2 years
Ratio of significant and non-significant cancers in individual categories of PI-RADS scores in patients indicated for biopsy.
9 secondary outcomes
Feasibility evaluation of a larger-scale study of screening for significant prostate cancer using an imaging modality:
Time frame: 2 years
Evaluation of complications after an interventional procedure (biopsy).
Time frame: 2 years
Evaluation of patient adherence to preventive examination - active recruitment.
Time frame: 2 years
Patient adherence to preventive examination - self-recruitment.
Time frame: 2 years
Patient adherence to preventive examination.
Time frame: 2 years
Evaluation of patient adherence to preventive examination.
Time frame: 2 years
Evaluation of patient adherence to preventive examination - completation of planned exams.
Time frame: 2 years
Evaluation of the financial burden of the study for the future preventive program of prostate cancer screening.
Time frame: 2 years
Detection and assessment of potential barriers to patient participation in the study. Assessment of patient adherence to remain in the study throughout the study period.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Background: PubMed 24439788Loeb 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.
- Background: PubMed 15163773Thompson 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.
- Background: PubMed 33172724Mottet 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.
- Background: PubMed 30824296Hugosson 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.
- Background: PubMed 12813170Draisma 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.
- Background: PubMed 26880413Nam 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.
- Background: PubMed 33570542Eldred-Evans D, Burak P, Connor MJ, Day E, Evans M, Fiorentino F, Gammon M, Hosking-Jervis F, Klimowska-Nassar N, McGuire W, Padhani AR, Prevost AT, Price D, Sokhi H, Tam H, Winkler M, Ahmed HU. Population-Based Prostate Cancer Screening With Magnetic Resonance Imaging or Ultrasonography: The IP1-PROSTAGRAM Study. JAMA Oncol. 2021 Mar 1;7(3):395-402. doi: 10.1001/jamaoncol.2020.7456.
- Background: PubMed 31167748van 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.
- Background: PubMed 31326219Drost 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.
- Background: PubMed 31706946Schoots 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.
- Background: PubMed 30396635Chiu 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.
- Background: PubMed 30898406Turkbey 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.
- Prostate cancer epidemiology in the Czech republic.Link provided by the sponsor.
- Epidemiology of malignant tumors in the Czech republicLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Staník, MD,PhD. principal investigator
Masaryk Memorial Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance, serum PSA examination and Biopsy in people with Prostate Cancer, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Standara, MD (00420 543 136 008, standara@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05603351, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.