Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorUniversity of Eastern Finland

About this trial

The goal of this clinical trial is to prospectively investigate the evolution of lesions in biparametric magnetic resonance imaging (bpMRI) of the prostate in men with no clinically significant prostate cancer (csPCa) in their initial biopsy. The main questions it aims to answer are:

Does lesion progression in bpMRI predict a diagnosis of csPCa in per-protocol follow-up biopsies?

What are the radiological and clinical risk factors for csPCa in per-protocol follow-up biopsies?

Eligibility criteria

Qualifiers

Suspicion of a local prostate cancer

Patient have 1-2 PI-RADS 3-5 lesion/lesions in biparametric prostate MRI, with no ISUP 2-5 prostate cancer in an initial systematic or lesion-targeted (at least two biopsy cores per lesion) biopsy

Prostate biopsies can be taken via transrectal approach in an outpatient clinic

An estimated life expentancy exceeding 10 years

Disqualifiers

The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.

The physician's suspicion of a locally advanced or a high risk prostate cancer. Absolute exclusion criteria are PSA >20 ng/ml or T4 staged prostate finding MRI or clinical examination

Seriuos infectious or non-infectious complication after initial biopsy

Deep immunosuppression due to organ transplant, hematologic disease, or related causes.

Trial design

Treatments tested in this trial

  • MRI

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators