Not Yet RecruitingNot Applicable

VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY

Argentina150 participantsStarted 2026-08-15

Plain-language summary

This study aims to prospectively validate the Fusion CEMEP score to assess the safety and efficacy of omitting systematic prostate biopsy in patients undergoing multiparametric magnetic resonance imaging-targeted biopsy. The main objective is to determine if target-only biopsy guided by the score is sufficient for clinically significant prostate cancer detection while reducing overtreatment and unnecessary cores.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult male patients with clinical suspicion of prostate cancer. * Patients scheduled to undergo multiparametric MRI-targeted prostate biopsy. * Signed informed consent. Exclusion Criteria: * Prior treatment for prostate cancer. * Contraindications to prostate biopsy or multiparametric MRI.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER

Timeframe: AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)

Trial details

NCT IDNCT07753356

SponsorMarcelo Ruben Oliva

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-20

Contact for this trial

MARCELO R OLIVA, MD

+541151409244 moliva.uba@gmail.com

View on ClinicalTrials.gov More Prostate Cancer trials