VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY

NCT07753356 | Not Yet Recruiting DMC

• 1 other identifier: CEMEP-2026-08-FUSION
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Prostatic Neoplasms/Diagnosis

Keywords

PROSTATE BIOPSY; MAGNETIC RESONANCE IMAGING; FUSION CEMEP SCORE

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (1)

FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT

Patients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score.

Other: FUSION CEMEP SCORE STRATEGY

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.

FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult male patients with clinical suspicion of prostate cancer.
• Patients scheduled to undergo multiparametric MRI-targeted prostate biopsy.
• Signed informed consent.

You may not qualify if:

• Prior treatment for prostate cancer.
• Contraindications to prostate biopsy or multiparametric MRI.

Sponsors & Collaborators

• Marcelo Ruben Oliva: lead

Study Sites (1)

Clinica Cemep

Rio Grande, Tierra del Fuego Province, 9420, Argentina

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MARCELO R OLIVA, MD

  CLINICA CEMEP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARCELO R OLIVA, MD

CONTACT

+541151409244; moliva.uba@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: UROLOGIST

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

AR (1)