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NCT Number: NCT07753356

VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE 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.

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Key information

Conditions

Prostate Cancer Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms/Diagnosis Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FUSION CEMEP SCORE STRATEGY

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

MARCELO R OLIVA, MD

CONTACT

[email protected]

+541151409244

Sponsors and collaborators

Lead sponsor

Marcelo Ruben Oliva

Other

Registry information

Official study title

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

Acronym: FUSION-CEMEP

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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