How prostate MRI lesions change over time with repeated biparametric scans
A Prospective Study of the Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
This trial will test whether changes seen on repeat biparametric prostate MRI predict clinically significant prostate cancer in men whose initial biopsy showed no significant cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | University of Eastern Finland Academic / other |
| Locations | 1 site (Kuopio) |
| Trial ID | NCT07369570 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men with suspected localized prostate cancer who have 1–2 PI-RADS 3–5 lesions on bpMRI, no ISUP grade 2–5 cancer on the qualifying biopsy, life expectancy over 10 years, and who are able to consent and communicate in Finnish.
Not a fit: Men with prior prostate biopsies before the qualifying biopsy, PSA >20 ng/ml, T4 disease, serious post-biopsy complications, deep immunosuppression, or those unable/unwilling to undergo repeat MRI and follow-up biopsies are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians use repeat bpMRI to better decide who needs a follow-up biopsy and reduce unnecessary procedures.
How similar studies have performed: Previous active-surveillance studies using serial multiparametric MRI have shown that lesion growth or radiologic upgrading can predict clinically significant prostate cancer, but prospective data specifically on repeat biparametric MRI are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kuopio
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
Study contacts
- Study coordinator: Juha Knaapila, MD, PhD
- Email: juha.knaapila@pshyvinvointialue.fi
- Phone: +358447178679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.