NCT05603351: ProstaPilot

Prostate Cancer Screening With Abbreviated MRI Protocol

Status unknown NA Last updated 2 November 2022

What this trial tests

NA trial testing magnetic resonance in Prostate Cancer in 300 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
30 June 2025

31 December 2025

Quick facts

Lead sponsor	Masaryk Memorial Cancer Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	300
Start date	1 May 2022
Primary completion	30 June 2025
Estimated completion	31 December 2025
Sites	1 location across Czechia

Drugs / interventions tested

• magnetic resonance
• serum PSA examination
• Biopsy — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Masaryk Memorial Cancer Institute

Who can join

Adults 50 to 69, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Screening for prostate cancer: evidence, ongoing trials, policies and knowledge gaps.
   Bratt O, Auvinen A, Arnsrud Godtman R, Hellström M, et al · · 2023 · cited 11× · PMID 39886507 · DOI 10.1136/bmjonc-2023-000039
2. Exploring motivations and barriers in prostate cancer screening: lessons from a volunteer-based MRI screening study.
   Světlák M, Standara M, Malatincová T, Staník M, et al · · 2025 · PMID 41334411 · DOI 10.3389/fpubh.2025.1646494
3. ProstaPilot: A Comparative Study of Biparametric Magnetic Resonance Imaging Versus Prostate-specific Antigen as a Screening Test for Prostate Cancer
   Staník M, Standara M, Miklánek D, Hejcmanová K, et al · · 2025