Prostate Cancer, Prostatic Neoplasms/Diagnosis
Conditions
Keywords
PROSTATE BIOPSY, MAGNETIC RESONANCE IMAGING, FUSION CEMEP SCORE
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.
Interventions
OTHERFUSION CEMEP SCORE STRATEGY
Guidance of prostate biopsy decisions based on the Fusion CEMEP score to determine the safety of omitting systematic biopsies.
Sponsors
Marcelo Ruben Oliva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER | 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. |
Countries
Argentina
Contacts
CONTACTMARCELO R OLIVA, MD
PRINCIPAL_INVESTIGATORMARCELO R OLIVA, MD
CLINICA CEMEP
Outcome results
None listed