Prostatic NeoplasmsLOC-CHOLINENCT06836154
Prostate Hyperfixation on PET-choline in Patients With Prostate Cancer: Correlation With MRI and Pathological Data (LOC-CHOLINE)
An observational study of Prostatic Neoplasms, run by University Hospital, Brest at 1 site in France.
Trial summary
In France, when prostate cancer is suspected, multiparametric MRI is the reference imaging technique for tumor localization, and is used to guide biopsies in order to characterize the tumor as accurately as possible. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2024to 31 Dec 2024
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent prostate MRI and PET-choline scans as part of initial staging of prostate cancer, followed by radical prostatectomy
Who may be able to join
- Patients who underwent initial MRI for suspected prostatic neoplasia
- Patients who have undergone a PET-choline scan as part of extension work-up.
- Patients who have undergone radical prostatectomy for curative treatment.
- Patients who have not expressed opposition to the use of data for clinical research purposes.
- Patients affiliated to French Social Security system.
Who cannot join
- Patient under legal protection
- Patient's refusal to allow his data to be used for clinical research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prostate Hyperfixation on PET-choline in Patients With Prostate Cancer: Correlation With MRI and Pathological Data
In France, when prostate cancer is suspected, multiparametric MRI is the reference imaging technique for tumor localization, and is used to guide biopsies in order to characterize the tumor as accurately as possible.
Under the hypothesis that 18 F-choline PET-CT is not inferior to MRI in localizing intra-prostate tumor foci, and could provide complementary data for biopsy, the localizing performance of these two imaging modalities is compared retrospectively, in patients with newly diagnosed prostate tumor treated by surgery.
Read the detailed description
Prostate cancer is the most common cancer among men in France. Diagnosis is based on multiple biopsies, including targeted biopsies after multiparametric MRI. Improving the precision of these targeted biopsies would improve early detection and staging of the disease.
PET-choline has already proved its superiority over MRI in localizing tumor foci in certain indications, particularly in prostate cancer.
Under the hypothesis that 18 F-choline PET-CT is not inferior to multiparametric MRI for the detection and localization of intraprostatic tumor foci, and could provide additional data for biopsy guidance, the performance of these two examinations was calculated in comparison with the gold standard (prostatectomy specimen), and then compared with each other, in patients newly diagnosed with prostate cancer and treated by radical prostatectomy.
For this purpose, all patients treated at Brest University Hospital by radical prostatectomy for prostatic neoplasia, and who underwent preoperative mpMRI and PET-choline from January 1, 2015 to April 30, 2020, were retrospectively analyzed.
Data were collected from available electronic medical records, including variables such as age at diagnosis, time between PET-choline and prostate biopsies, and the various clinico-biological components of the d'Amico classification (clinical T stage, PSA at diagnosis, biopsy Gleason score).
All multiparametric MRI, performed during the workup for suspected prostate cancer, were carried out in accordance with French recommendations (pelvi-prostatic MRI, 1.5T or 3T magnetic field, with the following sequences: three-dimensional T2-weighted over the prostate lodge; axial T2-weighted over the abdomino-pelvic floor; axial T1-weighted before and after dynamic injection of Gadolinium; axial diffusion-weighted over at least two different b-factors, with reconstruction of an ADC (Apparent Diffusion Coefficient) map).
All MRI were analyzed by an experienced radiologist specialized in prostate MRI interpretation. The MRI report was edited in accordance with AFU recommendations. It included the prostate volume with calculation of PSA density, a description of each suspicious area (PI-RADS ≥ 3) with its precise location and suspicion score according to the latest version of the PI-RADS score at the time the examination was carried out, and a standardized diagram showing the targets, their location and their PI-RADS score. In the case of suspected foci within the SFMA (Stroma Fibro-Musculaire Antérieur), the laterality of the focus was noted.
All 18F-choline PET/CT scans, performed as part of the prostate cancer extension work-up, were carried out in accordance with the French recommendation (3MBq/kg 18F-choline, 4h fasting, iodinated contrast medium and furosemide administered to patients in the absence of contraindication).
PET-choline data were analyzed by a nuclear physician experienced in analyzing these images. The prostate was segmented by sextant (6 segments: base/middle/apex, right/left). A segment was considered pathological if a hyperfixing focus stood out visually from the prostate background (as performed in routine practice). If a hyperfixing focus was located on several segments, a segment was considered pathological if the focus occupied more than 5mm within it.
The respective diagnostic performances of PET-choline and mpMRI (sensitivity, specificity) with 95% CI were calculated on the basis of the following definitions: true positive (TP): suspicious focus on imaging, confirmed as tumoral on the prostatectomy specimen; true negative (TN): no suspicious focus on imaging, no tumoral focus on prostatectomy specimen; false positive (FP): suspicious focus on imaging, no tumoral focus on prostatectomy specimen; false negative (FN): no suspicious focus on imaging, tumoral focus on prostatectomy specimen.
An analysis per patient, per lobe (i.e. right lobe/left lobe) and per segment was performed. For the per-patient analysis, since neither true negatives nor false positives (all patients had a prostate tumor) could be obtained, only sensitivity was calculated.
The respective diagnostic performances of PET-choline and mpMRI by lobe and by sextant were then compared, using statistical analyses such as Mac Nemar test and association coefficients.
Diagnostic performance according to sextant segmentation was then calculated by subgroup.
The relationship between the SUVmax of hyperfixing foci corresponding to tumor foci (VP), and the PSA level at diagnosis as well as the ISUP score of the tumor on the prostatectomy specimen was studied.
The respective mismatches between PET-choline and mpMRI imaging versus pathology on sextant analysis were described. The sextant diagnostic performance of the PET-choline/MRI combination was calculated, a sextant being considered positive if it presented a suspicious focus on MRI or a hyperfixed focus standing out from the prostatic background on PET-choline.
- Conditions
- Prostatic Neoplasms
- Keywords
- Positron-Emission Tomography, Choline, Multiparametric Magnetic Resonance Imaging, Biopsy
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local diagnostic performances of PET-choline in prostate cancer
For each sextant (i.e. base, middle, apex, right and left), the presence or absence (rated 1 or 0) of asuspicious focus on PET-choline will be compared with the presence or absence of a tumour focus on gold-standard (prostatectomy specimen). The diagnostic performances (sensitivity, specificity, negative predictive value and positive predictive value) of PET-choline will be deduced.
Measured: 8 months
Secondary outcomes (2)
Comparaison between IRM diagnostic performances and diagnostic PET-Choline performances
For each sextant (i.e. base, middle, apex, right and left), the presence or absence (rated 1 or 0) of a suspicious focus on mpMRI will be compared with the presence or absence of a tumour focus on gold-standard (prostatectomy specimen). The diagnostic performances (sensitivity, specificity, negative predictive value and positive predictive value) of mpMRI are then deduced.
These performances will then be compared with those of PET-choline
Measured: Through study completion, an average of 8 months
Local diagnostic performances of PET-choline in prostate cancer by subgroup
PSA level at diagnosis (i.e. PSA < 10 ng/ml and PSA ≥ 10 ng/ml), Clinical T stage (≤ T2a, T2b, and > T2b), ISUP stage of the prostatectomy specimen (ISUP < 3 and ≥ 3), derived from the Gleason histopronostic score, AMICO classification risk group, combining the results of Gleason score, clinical T stage and PSA level (Low-risk tumors : Stage T1c or T2a, PSA < 10 ng/mL and Gleason 6 // Intermediate-risk tumors : Stage T2b or T2c, PSA between 10 and 20 ng/mL and Gleason 7 // High-risk tumors (Stage T3, PSA > 20 ng/mL and Gleason > 7)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start12 Feb 2024
- Primary completion1 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836154
- Sponsor's protocol ID
- 29BRC23.0200 - LOC-CHOLINE
- Acronym
- LOC-CHOLINE
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Hyperfixation on PET-choline in Patients With Prostate Cancer: Correlation With MRI and Pathological Data
- ClinicalTrials.gov ID
- NCT06836154
- Acronym / sponsor ID
- LOC-CHOLINE / 29BRC23.0200 - LOC-CHOLINE
- Conditions
- Prostatic Neoplasms
- Keywords
- Positron-Emission Tomography, Choline, Multiparametric Magnetic Resonance Imaging, Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Feb 2025 (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.
In France, when prostate cancer is suspected, multiparametric MRI is the reference imaging technique for tumor localization, and is used to guide biopsies in order to characterize the tumor as accurately as possible.
Under the hypothesis that 18 F-choline PET-CT is not inferior to MRI in localizing intra-prostate tumor foci, and could provide complementary data for biopsy, the localizing performance of these two imaging modalities is compared retrospectively, in patients with newly diagnosed prostate tumor treated by surgery.
Detailed description
Prostate cancer is the most common cancer among men in France. Diagnosis is based on multiple biopsies, including targeted biopsies after multiparametric MRI. Improving the precision of these targeted biopsies would improve early detection and staging of the disease.
PET-choline has already proved its superiority over MRI in localizing tumor foci in certain indications, particularly in prostate cancer.
Under the hypothesis that 18 F-choline PET-CT is not inferior to multiparametric MRI for the detection and localization of intraprostatic tumor foci, and could provide additional data for biopsy guidance, the performance of these two examinations was calculated in comparison with the gold standard (prostatectomy specimen), and then compared with each other, in patients newly diagnosed with prostate cancer and treated by radical prostatectomy.
For this purpose, all patients treated at Brest University Hospital by radical prostatectomy for prostatic neoplasia, and who underwent preoperative mpMRI and PET-choline from January 1, 2015 to April 30, 2020, were retrospectively analyzed.
Data were collected from available electronic medical records, including variables such as age at diagnosis, time between PET-choline and prostate biopsies, and the various clinico-biological components of the d'Amico classification (clinical T stage, PSA at diagnosis, biopsy Gleason score).
All multiparametric MRI, performed during the workup for suspected prostate cancer, were carried out in accordance with French recommendations (pelvi-prostatic MRI, 1.5T or 3T magnetic field, with the following sequences: three-dimensional T2-weighted over the prostate lodge; axial T2-weighted over the abdomino-pelvic floor; axial T1-weighted before and after dynamic injection of Gadolinium; axial diffusion-weighted over at least two different b-factors, with reconstruction of an ADC (Apparent Diffusion Coefficient) map).
All MRI were analyzed by an experienced radiologist specialized in prostate MRI interpretation. The MRI report was edited in accordance with AFU recommendations. It included the prostate volume with calculation of PSA density, a description of each suspicious area (PI-RADS ≥ 3) with its precise location and suspicion score according to the latest version of the PI-RADS score at the time the examination was carried out, and a standardized diagram showing the targets, their location and their PI-RADS score. In the case of suspected foci within the SFMA (Stroma Fibro-Musculaire Antérieur), the laterality of the focus was noted.
All 18F-choline PET/CT scans, performed as part of the prostate cancer extension work-up, were carried out in accordance with the French recommendation (3MBq/kg 18F-choline, 4h fasting, iodinated contrast medium and furosemide administered to patients in the absence of contraindication).
PET-choline data were analyzed by a nuclear physician experienced in analyzing these images. The prostate was segmented by sextant (6 segments: base/middle/apex, right/left). A segment was considered pathological if a hyperfixing focus stood out visually from the prostate background (as performed in routine practice). If a hyperfixing focus was located on several segments, a segment was considered pathological if the focus occupied more than 5mm within it.
The respective diagnostic performances of PET-choline and mpMRI (sensitivity, specificity) with 95% CI were calculated on the basis of the following definitions: true positive (TP): suspicious focus on imaging, confirmed as tumoral on the prostatectomy specimen; true negative (TN): no suspicious focus on imaging, no tumoral focus on prostatectomy specimen; false positive (FP): suspicious focus on imaging, no tumoral focus on prostatectomy specimen; false negative (FN): no suspicious focus on imaging, tumoral focus on prostatectomy specimen.
An analysis per patient, per lobe (i.e. right lobe/left lobe) and per segment was performed. For the per-patient analysis, since neither true negatives nor false positives (all patients had a prostate tumor) could be obtained, only sensitivity was calculated.
The respective diagnostic performances of PET-choline and mpMRI by lobe and by sextant were then compared, using statistical analyses such as Mac Nemar test and association coefficients.
Diagnostic performance according to sextant segmentation was then calculated by subgroup.
The relationship between the SUVmax of hyperfixing foci corresponding to tumor foci (VP), and the PSA level at diagnosis as well as the ISUP score of the tumor on the prostatectomy specimen was studied.
The respective mismatches between PET-choline and mpMRI imaging versus pathology on sextant analysis were described. The sextant diagnostic performance of the PET-choline/MRI combination was calculated, a sextant being considered positive if it presented a suspicious focus on MRI or a hyperfixed focus standing out from the prostatic background on PET-choline.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent prostate MRI and PET-choline scans as part of initial staging of prostate cancer, followed by radical prostatectomy
Key inclusion criteria (5 listed)
- Patients who underwent initial MRI for suspected prostatic neoplasia
- Patients who have undergone a PET-choline scan as part of extension work-up.
- Patients who have undergone radical prostatectomy for curative treatment.
- Patients who have not expressed opposition to the use of data for clinical research purposes.
- Patients affiliated to French Social Security system.
Key exclusion criteria (2 listed)
- Patient under legal protection
- Patient's refusal to allow his data to be used for clinical research
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
Local diagnostic performances of PET-choline in prostate cancer
Time frame: 8 months
For each sextant (i.e. base, middle, apex, right and left), the presence or absence (rated 1 or 0) of asuspicious focus on PET-choline will be compared with the presence or absence of a tumour focus on gold-standard (prostatectomy specimen). The diagnostic performances (sensitivity, specificity, negative predictive value and positive predictive value) of PET-choline will be deduced.
2 secondary outcomes
Comparaison between IRM diagnostic performances and diagnostic PET-Choline performances
Time frame: Through study completion, an average of 8 months
Local diagnostic performances of PET-choline in prostate cancer by subgroup
Time frame: 8 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 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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?
An observational study of Prostatic Neoplasms, run by University Hospital, Brest 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 5 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: finished, as of the sponsor's last update on 20 Feb 2025. 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?
Local diagnostic performances of PET-choline in prostate cancer (time frame: 8 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 Feb 2025.