Prostate Cancer Screening With Abbreviated MRI Protocol

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

Interventions

DIAGNOSTIC_TEST

magnetic resonance

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

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.

Sponsors & Collaborators

• Masaryk University

  collaborator OTHER

• Masaryk Memorial Cancer Institute

  lead OTHER

Principal Investigators

• Michal Staník, MD,PhD. · Masaryk Memorial Cancer Institute

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

69 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• Czechia

Study Locations