Prostate Hyperfixation on PET-choline in Patients With Prostate Cancer: Correlation With MRI and Pathological Data (LOC-CHOLINE)

NCT06836154 | Completed

• 1 other identifier: 29BRC23.0200 - LOC-CHOLINE
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostatic Neoplasms

Keywords

Positron-Emission Tomography; Choline; Multiparametric Magnetic Resonance Imaging; Biopsy

Outcome Measures

Primary Outcomes (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.

  8 months

Secondary Outcomes (2)

• Comparaison between IRM diagnostic performances and diagnostic PET-Choline performances

  Through study completion, an average of 8 months

• Local diagnostic performances of PET-choline in prostate cancer by subgroup

  8 months

Eligibility Criteria

• Gender Eligibility Details: Condition requires to be a male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent prostate MRI and PET-choline scans as part of initial staging of prostate cancer, followed by radical prostatectomy

You may qualify if:

• 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.

You may not qualify if:

• Patient under legal protection
• Patient's refusal to allow his data to be used for clinical research

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: February 20, 2025
• Study Start: February 12, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)