Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging (REMRI)

University of Eastern Finland

Status: Begins enrollment this month

Conditions: Prostate Cancer (Diagnosis)

Treatments: Diagnostic Test: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT07369570

218/13.00/2025

Details and patient eligibility

About

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?

Enrollment: 100 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• The patient is cooperative, fluent in Finnish and understands the significance of the study
• The patient signs an informed consent form approved by the ethics committee.

Exclusion criteria

• 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.
• Any treatment given for prostate cancer diagnosed in initial biopsy
• Hip prosthesis or any other object in the pelvic area that affects high-quality MRI
• Claustrophobia or other absolute or relative contraindication for high-quality MRI

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Follow up arm

Experimental group

Description:

Follow-up MRI and biopsy

Treatment:

Diagnostic Test: MRI