Utilizing intraoperative frozen section examination (IFSE) for diagnosis and treatment in a high-clinical-suspicion prostate cancer (PCa) cohort based on 18F-PSMA PET/CT and MRI: a pilot study.

BACKGROUND: The diagnosis of prostate cancer (PCa) relies predominantly on definitive histopathological assessment. Although intraoperative frozen section examination (IFSE) is infrequently employed in prostate biopsy procedures, its integration with radical resection has been more widely adopted in other solid tumor settings. This study aims to evaluate the feasibility of an integrated diagnostic and therapeutic strategy-guided by IFSE-for patients with clinically high-risk or radiologically suspicious PCa.

METHODS: Patients with highly suspected PCa, characterized by 18F-labeled prostate-specific membrane antigen positron emission tomography/computed tomography (18F-PSMA PET/CT) standardized uptake value maximum (SUVmax) ≥8.4 and Prostate Imaging Reporting and Data System (PI-RADS) ≥4, were prospectively enrolled from March 2021 to December 2024. Targeted biopsies were conducted using a 16G biopsy needle in all patients, followed by IFSE of the biopsy tissues. For patients diagnosed with PCa via IFSE, radical prostatectomy (RP) was performed immediately. Clinical data, pathological results, perioperative conditions, and postoperative follow-up outcomes were analyzed.

RESULTS: A total of 56 patients were enrolled in the study. The median age was 67.4 years, with a median prostate-specific antigen (PSA) level of 22.2 ng/mL. Among the patients, 12 had a PI-RADS score of 4, and 44 had a score of 5. The median SUVmax value was 14.3. Twenty-two patients exhibited abnormal digital rectal examination (DRE) findings. IFSE confirmed PCa in all 56 patients (100%). All patients successfully underwent both targeted prostate biopsy and RP in a single surgical procedure. Postoperative pathology revealed positive surgical margins in 19 patients and seminal vesicle invasion in 4 patients. Tumor stages were distributed as follows: T2a (n=8), T2b (n=23), T2c (n=15), T3a (n=6), and T3b (n=4). Urinary continence was fully restored within 3 months postoperatively. Twenty-seven patients received adjuvant therapy. No biochemical recurrence was observed during follow-up.

CONCLUSIONS: For patients with highly suspicious PCa on imaging, the integrated diagnostic and therapeutic approach utilizing IFSE is feasible. This method serves as an effective complement to the traditional PCa management model. However, the appropriate standards and safety profile for this procedure remain to be fully established.