Prostate CancerBIOPROSTATIRMNCT05612204
Evaluation of Targeted Prostate Biopsies Under MRI: Tolerance and Contribution in the Therapeutic Decision - Exploratory Study
A study testing Biopsy under MRI in people with Prostate Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The goal of this clinical trial is to assess the concordance of treatment decisions made in multidisciplinary consultation meeting based on targeted biopsies alone or targeted biopsies associated with systematic biopsies in patients with suspected prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Biopsy under MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male, aged between ≥ 50 and ≤ 75 years old
- Patient with no history of prostate biopsy
- Patient with a PSA greater than 4 and/or a pathological digital rectal examination
- Patient having an MRI of interpretable quality carried out within the HPA
- Patient with a single lesion with a PI-RADS score ≥ 3
- Affiliated patient or beneficiary of a social security scheme
- French-speaking patient who signed an informed consent
Who cannot join
- Patient with a contraindication to MRI
- Patient with multiple targets
- Patient with lesions with PI-RADS score 1 and 2
- Patient on long-term anticoagulants and unable to stop it
- Patient already included in another study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Patient hospitalized without consent
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to assess the concordance of treatment decisions made in multidisciplinary consultation meeting based on targeted biopsies alone or targeted biopsies associated with systematic biopsies in patients with suspected prostate cancer.
Read the detailed description
Prostate cancer is the most common cancer in France and is the third most common cancer death in men.
Early detection is based on family and ethnic history, digital rectal examination and total PSA testing. It is done at age 50 for the general population but is restricted to men with an estimated survival of more than 10 years.
In case of clinical suspicion of prostate cancer, the diagnosis is based on the realization of prostate biopsies. Until recently, 12 so-called "systematic" (BS) biopsies were performed under ultrasound control, according to a standardized protocol, which allowed sampling of the entire prostate.
Since the latest recommendations of the French Association of Urology in 2020, an MRI is systematically indicated before performing biopsies. Indeed, MRI is a sensitive technique that will increase the suspicion of significant prostate cancer. An MRI is considered "positive" if at least one suspicious area with a PI-RADS score ≥ 3 is detected. In this case, the French Association of Urology recommends performing so-called targeted biopsies (BC) on these suspicious areas associated with the 12 SBs.
From a technical point of view, ultrasound is the reference examination for performing targeted biopsies on suspicious lesions detected on MRI, either by visual guidance (cognitive identification) or by image fusion techniques, MRI and ultrasound.
It is now technically possible to perform biopsies directly under MRI in clinical practice, but the development of this approach remains limited in France. This technique makes it possible to biopsy the suspect area without resorting to image fusion, thus limiting targeting errors.
As only MRI can detect cancerous lesions, this study is based on the hypothesis that targeted biopsies alone taken under MRI could make it possible to make a therapeutic decision within the framework of a multidisciplinary consultation meeting (RCP) without resorting to systematic biopsies under ultrasound.
- Conditions
- Prostate Cancer
- Being tested
- Biopsy under MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy under MRIProcedure or surgery
Biopsy under MRI
| Study group | Role | What they receive |
|---|---|---|
| Biopsy under MRI | Experimental | Not described Receives: Procedure: Biopsy under MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of care offered in multidisciplinary consultation meeting
Measured: 2 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start21 Nov 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612204
- Sponsor's protocol ID
- 2022-A00792-41
- Acronym
- BIOPROSTATIRM
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Targeted Prostate Biopsies Under MRI: Tolerance and Contribution in the Therapeutic Decision - Exploratory Study
- ClinicalTrials.gov ID
- NCT05612204
- Acronym / sponsor ID
- BIOPROSTATIRM / 2022-A00792-41
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Nov 2022 (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.
The goal of this clinical trial is to assess the concordance of treatment decisions made in multidisciplinary consultation meeting based on targeted biopsies alone or targeted biopsies associated with systematic biopsies in patients with suspected prostate cancer.
Detailed description
Prostate cancer is the most common cancer in France and is the third most common cancer death in men.
Early detection is based on family and ethnic history, digital rectal examination and total PSA testing. It is done at age 50 for the general population but is restricted to men with an estimated survival of more than 10 years.
In case of clinical suspicion of prostate cancer, the diagnosis is based on the realization of prostate biopsies. Until recently, 12 so-called "systematic" (BS) biopsies were performed under ultrasound control, according to a standardized protocol, which allowed sampling of the entire prostate.
Since the latest recommendations of the French Association of Urology in 2020, an MRI is systematically indicated before performing biopsies. Indeed, MRI is a sensitive technique that will increase the suspicion of significant prostate cancer. An MRI is considered "positive" if at least one suspicious area with a PI-RADS score ≥ 3 is detected. In this case, the French Association of Urology recommends performing so-called targeted biopsies (BC) on these suspicious areas associated with the 12 SBs.
From a technical point of view, ultrasound is the reference examination for performing targeted biopsies on suspicious lesions detected on MRI, either by visual guidance (cognitive identification) or by image fusion techniques, MRI and ultrasound.
It is now technically possible to perform biopsies directly under MRI in clinical practice, but the development of this approach remains limited in France. This technique makes it possible to biopsy the suspect area without resorting to image fusion, thus limiting targeting errors.
As only MRI can detect cancerous lesions, this study is based on the hypothesis that targeted biopsies alone taken under MRI could make it possible to make a therapeutic decision within the framework of a multidisciplinary consultation meeting (RCP) without resorting to systematic biopsies under ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy under MRI | Experimental | Procedure: Biopsy under MRI |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient, male, aged between ≥ 50 and ≤ 75 years old
- Patient with no history of prostate biopsy
- Patient with a PSA greater than 4 and/or a pathological digital rectal examination
- Patient having an MRI of interpretable quality carried out within the HPA
- Patient with a single lesion with a PI-RADS score ≥ 3
Key exclusion criteria (7 listed)
- Patient with a contraindication to MRI
- Patient with multiple targets
- Patient with lesions with PI-RADS score 1 and 2
- Patient on long-term anticoagulants and unable to stop it
- Patient already included in another study
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 |
|---|---|---|
| Biopsy under MRIBiopsy under MRI | Procedure or surgery | Biopsy under MRI |
Primary outcome
Type of care offered in multidisciplinary consultation meeting
Time frame: 2 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy under MRI in people with Prostate Cancer, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 20 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of care offered in multidisciplinary consultation meeting (time frame: 2 MONTHS). 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 20 Aug 2026.