An observational study in Prostate Cancer and Prostatic Neoplasms/Diagnosis, sponsored by Marcelo Ruben Oliva. Not yet recruiting at 1 site in Argentina. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Marcelo Ruben Oliva · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 150 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Marcelo Ruben Oliva as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Male patients evaluated at the clinic with clinical suspicion of prostate cancer undergoing MRI-targeted biopsy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score.
Other: FUSION CEMEP SCORE STRATEGY
Guidance of prostate biopsy decisions based on the Fusion CEMEP score to determine the safety of omitting systematic biopsies.
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)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 16 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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