Prostate Cancer Screening With Abbreviated MRI Protocol (ProstaPilot)

October 30, 2022 updated by: Masaryk Memorial Cancer Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michal Standara, MD
  • Phone Number: 00420 543 136 008
  • Email: standara@mou.cz

Study Contact Backup

Study Locations

  • Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia, 65653
        • Recruiting
        • Masaryk Memorial Cancer Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michal Stanik, Ass.Prof.
        • Sub-Investigator:
          • Michal Standara, MD
        • Sub-Investigator:
          • Jan Kristek, PhD
        • Sub-Investigator:
          • Alexandr Poprach, Ass.Prof.
        • Sub-Investigator:
          • Milos Pacal, MD
        • Sub-Investigator:
          • Iva Babankova, MD
        • Sub-Investigator:
          • David Miklanek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preventive prostate examination by bpMRI

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
biparametric MRI with protocol including anatomical T2 sequence and diffusion-weighted images (DWI), according to the standards
Other Names:
  • MRI
Diagnostic test: serum PSA examination
testing of prostate-specific antigen (PSA) in serum
Procedure: Biopsy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 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.
2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility evaluation of a larger-scale study of screening for significant prostate cancer using an imaging modality:
Time Frame: 2 years
Concordance rate (%) between radiologists performing MRI scoring.
2 years
Evaluation of complications after an interventional procedure (biopsy).
Time Frame: 2 years
Number of complications after biopsy.
2 years
Evaluation of patient adherence to preventive examination - active recruitment.
Time Frame: 2 years
Number of participants who agreed to be included in the study through used recruitment strategies.
2 years
Patient adherence to preventive examination - self-recruitment.
Time Frame: 2 years
Number of participants who contacted the team themselves with a request for testing.
2 years
Patient adherence to preventive examination.
Time Frame: 2 years
Number of participants who signed the informed consent and were enrolled in the study.
2 years
Evaluation of patient adherence to preventive examination.
Time Frame: 2 years
Number of participants who visited a screening facility.
2 years
Evaluation of patient adherence to preventive examination - completation of planned exams.
Time Frame: 2 years
Number of participants who completed the designated examination.
2 years
Evaluation of the financial burden of the study for the future preventive program of prostate cancer screening.
Time Frame: 2 years
Costs of individual inclusion and screening tests.
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
Numbers and reasons of participants who did not complete scheduled tests, follow-up examinations, or withdrew informed consent.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk Memorial Cancer Institute

Collaborators

Masaryk University

Investigators

  • Principal Investigator: Michal Staník, MD,PhD., Masaryk Memorial Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

June 30, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

October 30, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 30, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU22-09-00539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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