Prostate CancerNCT04692207
Prostate Biopsies With Target Lesion on MRI
An observational study of Prostate Cancer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 30 Oct 2020
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had a prostate MRI between June 2017 and March 2020 for suspected cancer, followed by targeted and non-targeted prostate biopsies (12) at the Montpellier University Hospital
Who may be able to join
- Age > or = at 18 years old
- Prostatic MRI performed at the Montpellier University Hospital
- Realization of targeted prostate biopsies (by fusion of MRI - ultrasound images) and non-targeted biopsies
Who cannot join
- Pre-biopsy MRI performed outside of the Montpellier University Hospital
- MRI with artefacts
- Not performing 12 non-targeted prostate biopsies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With
Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).
- Conditions
- Prostate Cancer
- Keywords
- Targeted prostate biopsy, Non-targeted prostate biopsy, MRI, prostate, biopsy
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies
Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jun 2017
- Primary completion1 May 2020
- Study completion30 Oct 2020
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
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Millet, PUPH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692207
- Sponsor's protocol ID
- RECHMPL20_0684
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With
- ClinicalTrials.gov ID
- NCT04692207
- Acronym / sponsor ID
- RECHMPL20_0684
- Conditions
- Prostate Cancer
- Keywords
- Targeted prostate biopsy, Non-targeted prostate biopsy, MRI, prostate, biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 31 Dec 2020 (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.
Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a prostate MRI between June 2017 and March 2020 for suspected cancer, followed by targeted and non-targeted prostate biopsies (12) at the Montpellier University Hospital
Key inclusion criteria (3 listed)
- Age > or = at 18 years old
- Prostatic MRI performed at the Montpellier University Hospital
- Realization of targeted prostate biopsies (by fusion of MRI - ultrasound images) and non-targeted biopsies
Key exclusion criteria (3 listed)
- Pre-biopsy MRI performed outside of the Montpellier University Hospital
- MRI with artefacts
- Not performing 12 non-targeted prostate biopsies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies
Time frame: 1 month
Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies
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 5 Jan 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Ingrid Millet, PUPH study director
University Hospital, Montpellier
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, run by University Hospital, Montpellier 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 3 inclusion and 3 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 5 Jan 2021. 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?
Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies (time frame: 1 month). 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 5 Jan 2021.