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

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Conditions studied: Prostate Cancer

In brief

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 facts

Study ID: NCT07709403
Run by: Peking University First Hospital
People needed: 20
Starts: 2026-08-01
Expected to finish: 2027-06-30
Last updated by the study team: 2026-07-16

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Age 18-80 years;
Meeting clinical indications for prostate biopsy (serum PSA persistently >4 ng/mL, and at least one lesion with PI-RADS ≥ 3 on magnetic resonance imaging [MRI]);
At least one suspicious lesion detected on PSMA PET/CT;
No prior prostate biopsy

You may not qualify if…

Prior chemotherapy, pelvic radiotherapy, or androgen deprivation therapy (ADT) for prostate cancer;
Prior prostate surgery (transurethral resection of the prostate, etc.);
Any contraindications to prostate biopsy, such as active urinary tract infection or indwelling urinary catheter;
Biopsy core data with failed gamma spectrometer measurement due to technical reasons.

Full record on ClinicalTrials.gov

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