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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Chu Brest

    Brest, 29609

Other trials in France

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.

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.

  1. 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)
  1. 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

  2. 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.

  1. First posted20 Feb 2025
  2. Study start12 Feb 2024
  3. Primary completion1 Jun 2024
  4. Study completion31 Dec 2024

Resources

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)
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

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.

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