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Not yet recruiting NCT07753356

VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY

— Observational Prostate Cancer Prostatic Neoplasms/Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FUSION CEMEP SCORE STRATEGY.
Who it may be relevant to
Registry conditions: Prostate Cancer, Prostatic Neoplasms/Diagnosis. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Argentina
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other FUSION CEMEP SCORE STRATEGY
    Guidance of prostate biopsy decisions based on the Fusion CEMEP score to determine the safety of omitting systematic biopsies.

Primary outcome measures

  • DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER [Time frame: AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Argentina · 1 center
  • Clinica Cemep — Rio Grande

Identifiers

NCT: NCT07753356 · CEMEP-2026-08-FUSION

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗