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

Sponsor
Peking University First Hospital
Study ID
NCT07709403
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • No intervention (observational study) — OTHER
    No intervention

Study Details

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.

Key Dates

First listed
Jul 16, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Group 1
    This study is a prospective observational cohort study enrolling 20 patients with suspected prostate cancer. It does not involve any additional medical intervention beyond the routine biopsy procedure, with the only addition being radioactive counting of biopsy specimens.

Primary Outcome Measure

Diagnostic performance of core-level CPM [ Time Frame: Periprocedural ]

Central Contacts

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