Prostatic NeoplasmPROSTEPIRMNCT02971995
Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies
A study testing PET Scan ou TEP-TDM and mpMRI in people with Prostatic Neoplasm and Positron-Emission Tomography, run by Lille Catholic University.
Trial summary
Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm, Positron-Emission Tomography, Fluorocholine
- What is being tested?
- PET Scan ou TEP-TDM and mpMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Oct 2016
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspicion of prostate cancer
- Patients who performed prostate mpMRI and F-Choline 18 PET scan
- Patient capable of receiving clear informations
- Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
- Patient covered by a healthcare insurance
Who cannot join
- Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan
About this study
Official title: Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients
Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).
The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .
- Being tested
- PET Scan ou TEP-TDM, mpMRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Scan ou TEP-TDMDevice
Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy
mpMRIDevice
Performance of the mpMRI in order to determine the place where to take the biopsy
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer/TEP scan | Experimental | Not described Receives: Device: PET Scan ou TEP-TDM |
| Prostate cancer/mpMRI | Active comparator | Not described Receives: Device: mpMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of image guided prostate biopsy in the zones detected by the TEP scan
Measured: at inclusion
Secondary outcomes (1)
Number of image guided prostate biopsy in the zones detected by the mpMRI
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionOct 2016
Why it stopped: Difficulties encountered in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Louis Bonnal, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971995
- Sponsor's protocol ID
- OBS025
- Acronym
- PROSTEPIRM
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT02971995
- Acronym / sponsor ID
- PROSTEPIRM / OBS025
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties encountered in enrolling patients
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Nov 2016 (estimated)
- 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.
Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).
The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer/TEP scan | Experimental | Device: PET Scan ou TEP-TDM |
| Prostate cancer/mpMRI | Active comparator | Device: mpMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with suspicion of prostate cancer
- Patients who performed prostate mpMRI and F-Choline 18 PET scan
- Patient capable of receiving clear informations
- Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
- Patient covered by a healthcare insurance
Key exclusion criteria (1 listed)
- Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan
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 |
|---|---|---|
| PET Scan ou TEP-TDMPerformance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy | Device | Prostate cancer/TEP scan |
| mpMRIPerformance of the mpMRI in order to determine the place where to take the biopsy | Device | Prostate cancer/mpMRI |
Primary outcome
Number of image guided prostate biopsy in the zones detected by the TEP scan
Time frame: at inclusion
1 secondary outcome
Number of image guided prostate biopsy in the zones detected by the mpMRI
Time frame: at inclusion
Results and safety
The study was stopped early (reason given: Difficulties encountered in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Jean Louis Bonnal, MD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
A study testing PET Scan ou TEP-TDM and mpMRI in people with Prostatic Neoplasm and Positron-Emission Tomography, run by Lille Catholic University.
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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Difficulties encountered in enrolling patients). Results are not available in the source record.
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?
Number of image guided prostate biopsy in the zones detected by the TEP scan (time frame: at inclusion). 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 12 Jun 2026.