VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY (FUSION-CEMEP)

August 4, 2026 updated by: Marcelo Ruben Oliva

VALIDATION OF THE FUSION CEMEP SCORE FOR THE OMISSION OF SYSTEMATIC PROSTATE BIOPSY IN PATIENTS UNDERGOING MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING-TARGETED BIOPSY

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Tierra del Fuego Province
      • Rio Grande, Tierra del Fuego Province, Argentina, 9420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male patients evaluated at the clinic with clinical suspicion of prostate cancer undergoing MRI-targeted biopsy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT
Patients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score.
Other: FUSION CEMEP SCORE STRATEGY
Guidance of prostate biopsy decisions based on the Fusion CEMEP score to determine the safety of omitting systematic biopsies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER
Time Frame: AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)
Percentage of patients diagnosed with clinically significant prostate cancer (Gleason score >= 7) using the target-only biopsy guided by the Fusion CEMEP score compared to the full systematic scheme.
AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marcelo Ruben Oliva

Investigators

  • Principal Investigator: MARCELO R OLIVA, MD, Clinica Cemep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

August 4, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 7, 2026

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEMEP-2026-08-FUSION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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