VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY

N/ANot Yet RecruitingNCT07753356

Marcelo Ruben Oliva150 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Prostate Cancer Prostatic Neoplasms/Diagnosis

Interventions

FUSION CEMEP SCORE STRATEGYOTHER

Guidance of prostate biopsy decisions based on the Fusion CEMEP score to determine the safety of omitting systematic biopsies.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinica Cemep

Rio Grande, Tierra del Fuego Province, Argentina

Outcomes

Primary Outcomes

DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER

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.

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

Central Contacts

MARCELO R OLIVA, MD

CONTACT

+541151409244 moliva.uba@gmail.com

Data from ClinicalTrials.gov

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