How prostate MRI lesions change over time with repeated biparametric scans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective interventional study follows men who have 1–2 PI-RADS 3–5 lesions on biparametric prostate MRI but no ISUP grade ≥2 cancer on their initial targeted or systematic biopsy. Participants undergo scheduled repeat bpMRI and per-protocol follow-up biopsies (transrectal outpatient approach) to document lesion evolution and biopsy outcomes. The investigators will correlate radiologic changes with clinical variables to identify risk factors for subsequent clinically significant prostate cancer. The goal is to determine whether imaging progression on serial bpMRI can guide the need for repeat biopsy and earlier treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Kuopio University Hospital
  Kuopio, Finland Recruiting

Study contacts

• Study coordinator: Juha Knaapila, MD, PhD
• Email: juha.knaapila@pshyvinvointialue.fi
• Phone: +358447178679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.