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.
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
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.
Patients undergoing prostate biopsy at Peking University First Hospital due to suspected prostate cancer and meeting eligibility criteria
Cohort
Prospective
No intervention (observational study)
Other interventionNo intervention
Diagnostic performance of core-level CPM
Diagnostic performance of core-level CPM in differentiating cancer-positive from cancer-negative cores, expressed as area under the curve (AUC)
Determination of the optimal CPM cutoff value
Determination of the optimal CPM cutoff value for intraoperative real-time prediction of cancer-positive cores.
Correlations of CPM with pathological features
Correlations of CPM with pathological ISUP grade, tumor length, and PSMA expression level detected by immunohistochemistry (IHC).
Proportion of cores in which clinically significant prostate cancer (csPCa) is detected on the first or second core and that exhibit high CPM counts
Proportion of cores in which clinically significant prostate cancer (csPCa) is detected on the first or second core and that exhibit high CPM counts
Histopathological characteristics of false-positive and false-negative cores
Microscopic pathological features of biopsy cores in which the CPM-based real-time prediction disagrees with the final histopathological diagnosis. For false-positive cores (CPM ≥ cutoff but pathology-negative), we will examine whether the radioactive signal arises from benign histological mimics that express PSMA, such as benign prostatic hyperplasia (BPH), prostatic intraepithelial neoplasia (PIN), inflammation, or stromal components. For false-negative cores (CPM \< cutoff but pathology-positive), we will characterize tumor-related histological features that may account for low radioactive uptake, including low tumor grade (ISUP grade 1-2), small tumor foci (microfoci), perineural invasion, or intratumoral heterogeneity in PSMA expression.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
