Dual-tracer PET Radiomics for Prostate Cancer Stratification

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.

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Key information

Conditions

Prostate Cancer Biochemical Recurrence Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gleason Score Male Urogenital Diseases Neoplasms Neoplasms by Site PET/CT Prostatic Diseases Prostatic Neoplasms Radiomics Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Department of Nuclear Medicine, Xiangya Hospital, Central South University

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Gleason Grade Group

Time frame: 2020.1 --- 2023.1

Gleason Grade Group

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: Jun 18, 2026
Registry last updated: Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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