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Dual-tracer PET Radiomics for Prostate Cancer Stratification

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07655648
Enrollment
100
Registered
2026-06-18
Start date
2020-01-01
Completion date
2026-05-01
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTPET/CT with Gallium-68 labeled PSMA and RM26

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

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gleason Grade Group2020.1 --- 2023.1Gleason Grade Group

Secondary

MeasureTime frameDescription
Biochemical recurrence-free survivalFrom 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026