Prostate CancerFUSION-CEMEPNCT07753356
VALIDATION OF FUSION CEMEP SCORE FOR OMITTING SYSTEMATIC PROSTATE BIOPSY
An observational study of Prostate Cancer and Prostatic Neoplasms/Diagnosis, run by Marcelo Ruben Oliva at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms/Diagnosis
- What is being tested?
- FUSION CEMEP SCORE STRATEGY
- How many people
- 150 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Aug 2026to 30 Dec 2029
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients evaluated at the clinic with clinical suspicion of prostate cancer undergoing MRI-targeted biopsy.
Who may be able to join
- Adult male patients with clinical suspicion of prostate cancer.
- Patients scheduled to undergo multiparametric MRI-targeted prostate biopsy.
- Signed informed consent.
Who cannot join
- Prior treatment for prostate cancer.
- Contraindications to prostate biopsy or multiparametric MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site
Clinica Cemep
Rio Grande, Tierra del Fuego Province, 9420
MARCELO R OLIVA, MD, +541151409244, moliva.uba@gmail.com
MARCELO R OLIVA, MD, moliva.uba@gmail.com
About this study
Official title: VALIDATION OF THE FUSION CEMEP SCORE FOR THE OMISSION OF SYSTEMATIC PROSTATE BIOPSY IN PATIENTS UNDERGOING MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING-TARGETED 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.
- Conditions
- Prostate Cancer, Prostatic Neoplasms/Diagnosis
- Being tested
- FUSION CEMEP SCORE STRATEGY
- Keywords
- PROSTATE BIOPSY, MAGNETIC RESONANCE IMAGING, FUSION CEMEP SCORE
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FUSION CEMEP SCORE STRATEGYOther
Guidance of prostate biopsy decisions based on the Fusion CEMEP score to determine the safety of omitting systematic biopsies.
| Study group | Role | What they receive |
|---|---|---|
| FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT | Patients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score. Receives: Other: FUSION CEMEP SCORE STRATEGY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion20 Dec 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Marcelo Ruben Oliva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcelo Ruben Oliva, Servicio Urologia CEMEP
- Investigators
- MARCELO R OLIVA, MD, Principal investigator, CLINICA CEMEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753356
- Sponsor's protocol ID
- CEMEP-2026-08-FUSION
- Acronym
- FUSION-CEMEP
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALIDATION OF THE FUSION CEMEP SCORE FOR THE OMISSION OF SYSTEMATIC PROSTATE BIOPSY IN PATIENTS UNDERGOING MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING-TARGETED BIOPSY
- ClinicalTrials.gov ID
- NCT07753356
- Acronym / sponsor ID
- FUSION-CEMEP / CEMEP-2026-08-FUSION
- Conditions
- Prostate Cancer, Prostatic Neoplasms/Diagnosis
- Keywords
- PROSTATE BIOPSY, MAGNETIC RESONANCE IMAGING, FUSION CEMEP SCORE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Marcelo Ruben OlivaUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT | – | Other: FUSION CEMEP SCORE STRATEGYPatients evaluated with multiparametric MRI-targeted biopsy using the Fusion CEMEP score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients evaluated at the clinic with clinical suspicion of prostate cancer undergoing MRI-targeted biopsy.
Key inclusion criteria (3 listed)
- Adult male patients with clinical suspicion of prostate cancer.
- Patients scheduled to undergo multiparametric MRI-targeted prostate biopsy.
- Signed informed consent.
Key exclusion criteria (2 listed)
- Prior treatment for prostate cancer.
- Contraindications to prostate biopsy or multiparametric MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FUSION CEMEP SCORE STRATEGYGuidance of prostate biopsy decisions based on the Fusion CEMEP score to determine the safety of omitting systematic biopsies. | Other | FUSION CEMEP SCORE COHORT, PROSPECTIVE COHORT |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MARCELO R OLIVA, MD principal investigator
CLINICA CEMEP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostatic Neoplasms/Diagnosis, run by Marcelo Ruben Oliva at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARCELO R OLIVA, MD (+541151409244, moliva.uba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DETECTION RATE OF CLINICALLY SIGNIFICANT PROSTATE CANCER (time frame: AT THE TIME OF PROSTATE BIOPSY (WITHIN 30 DAYS OF EVALUATION)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.