VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY

Sponsor
Marcelo Ruben Oliva
Study ID
NCT07753356
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 15, 2026
Status verified
Aug 2026
Primary completion
Dec 20, 2027
Completion
Dec 30, 2029

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT
    Patients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score.

Primary Outcome Measure

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

Central Contacts

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