Dual-tracer PET Radiomics for Prostate Cancer Stratification

NCT07655648 | Completed

• 1 other identifier: KY20260315
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center retrospective study aims to develop an interpretable radiomics model based on dual-tracer PET/CT to preoperatively predict the postoperative pathological Gleason grade group in treatment-naïve prostate cancer patients. A machine learning-based three-class prediction model will be constructed and interpreted using SHAP. Its performance will be compared with systematic biopsy results, assessing grading accuracy and prognostic value for biochemical recurrence-free survival.

Conditions

Prostate Cancer; Gleason Score; PET/CT; Radiomics; Biochemical Recurrence

Outcome Measures

Primary Outcomes (1)

• Gleason Grade Group

  Gleason Grade Group

  2020.1 --- 2023.1

Secondary Outcomes (1)

• Biochemical recurrence-free survival

  From surgery to biochemical recurrence or study cutoff (up to 5 years)

Study Arms (1)

Retrospective Cohort

Treatment-naïve prostate cancer patients undergoing dual-tracer PET/CT before radical prostatectomy.

Diagnostic Test: PET/CT with Gallium-68 labeled PSMA and RM26

Interventions

PET/CT with Gallium-68 labeled PSMA and RM26 DIAGNOSTIC_TEST

Retrospective analysis of pre-prostatectomy dual-tracer PET/CT (⁶⁸Ga-PSMA and ⁶⁸Ga-RM26) imaging data.

Retrospective Cohort

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive treatment-naïve prostate cancer patients from a single center with available pre-RP dual-tracer PET/CT, biopsy, and RP pathology data.

You may qualify if:

• Treatment-naïve prostate cancer with subsequent radical prostatectomy (RP)
• Availability of presurgical dual-tracer PET/CT images, biopsy, and RP pathology data

You may not qualify if:

• Unavailability of imaging or pathological data
• PET/CT performed after any prostate cancer-related treatment
• Interval between PET and biopsy \> 3 months
• Interval between biopsy and RP \> 1 month

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Department of Nuclear Medicine, Xiangya Hospital, Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 18, 2026
• Study Start: January 1, 2020
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)