About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- No intervention (observational study)