About this trial
Development of an Intelligent System Integrating Preoperative Imaging and Real-Time Intraoperative Metabolic Feedback to Dynamically Optimize Biopsy core Placement for Individualized Precision Sampling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥55 years;
Indication for prostate biopsy;
Availability of total prostate-specific antigen (tPSA), free PSA (fPSA) levels, and multiparametric MRI (mpMRI) results within 1 month prior to biopsy.
Disqualifiers
Pathological diagnosis of malignancies other than prostatic acinar adenocarcinoma;
Concomitant malignant tumors potentially affecting imaging findings (e.g., rectal, bladder, or testicular cancer);
Cachexia or organ function decompensation.
Trial population
Patients who underwent prostate biopsy at three medical centers in Shanghai: Minhang Hospital, Fudan University; Xuhui Hospital, Fudan University and Shanghai Geriatric Medical Center
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Mean number of biopsy cores required to achieve a definitive diagnosis in the adaptive biopsy group
Secondary outcomes
Prostate cancer detection rate
Missed diagnosis rates in the adaptive biopsy group and the mpMRI-US fusion-targeted biopsy group
The time of biopsy
Complication rate
Sponsors and contacts
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