NCT07369570Recruiting
Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
A Prospective Study of the Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Dec 2025
- Start date
- 23 Feb 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Eastern Finland
- Diseases
- Prostate cancer
- NCT number
- NCT07369570
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 23 Feb 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.
Other illness
- 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
- Deep immunosuppression due to organ transplant, hematologic disease, or related causes.
- Any treatment given for prostate cancer diagnosed in initial biopsy
Other
- Seriuos infectious or non-infectious complication after 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
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.