Dual-tracer PET Radiomics for Prostate Cancer Stratification

June 17, 2026 updated by: Yongxiang Tang, Xiangya Hospital of Central South University

Dual-tracer PET/CT Interpretable Radiomics for Pathological Classification and Prognostic Stratification of Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Department of Nuclear Medicine, Xiangya Hospital, Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gleason Grade Group
Time Frame: 2020.1 --- 2023.1
Gleason Grade Group
2020.1 --- 2023.1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical recurrence-free survival
Time Frame: From surgery to biochemical recurrence or study cutoff (up to 5 years)
Time from surgery to biochemical recurrence (PSA ≥ 0.2 ng/ml or initiation of salvage treatment) or last follow-up.
From surgery to biochemical recurrence or study cutoff (up to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

May 1, 2026

Study Completion (Actual)

May 1, 2026

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 17, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20260315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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