Clinical Trial

Radioactive Counts From PSMA PET/CT-Targeted Biopsy Specimens for Real-time Diagnosis of Prostate Cancer: A Prospective Study

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Summary
This study aims to establish the diagnostic threshold and efficacy of radioactive counts (CPM) from biopsy specimens in distinguishing cancer-containing from non-cancer-containing cores, using prostate biopsy pathology as the gold standard. On this basis, we quantitatively analyze the correlations between CPM and both tumor ISUP grade and tumor length, thereby inversely calibrating the pathological significance of PSMA PET/CT imaging signals. Furthermore, we seek to preliminarily define a reference range of imaging signal intensity sufficient to safely obviate the need for biopsy, thereby providing direct pathological evidence to advance non-invasive, biopsy-free diagnosis of prostate cancer.
Trial Details
NCT Number NCT07709403
Lead Sponsor Peking University First Hospital
Conditions Prostate Cancer
Enrollment 20 participants
Start Date 2026-08-01
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-16