68-Gallium PSMA PET/CT–guided robotic arm–assisted transgluteal prostate biopsy versus TRUS-guided fusion biopsy: diagnosis of clinically significant cancer and comparative morbidity in a prospective Indian cohort

Abstract Purpose To compare the diagnostic accuracy and periprocedural complications of 68Ga-PSMA PET/CT–guided robotic arm–assisted transgluteal prostate biopsy (PSMA-TB) with transrectal ultrasound–guided cognitive fusion biopsy (TRUS-GB) for detecting clinically significant prostate cancer (csPCa) in Indian men. Methods In this prospective single-centre study (January 2021–December 2024), 216 men aged 50–80 years with suspected prostate cancer (PSA > 4 ng/mL, abnormal DRE or PI-RADS ≥ 3) underwent standardized evaluation. All eligible patients underwent 68Ga-PSMA PET/CT. Patients with PSMA-avid intraprostatic lesions (SUVmax ≥ 8.0) underwent targeted robotic transgluteal biopsy (3–4 cores). Those with low/negative PET findings and matched controls underwent 12-core TRUS-GB. The primary endpoint was detection of csPCa (Gleason score ≥ 7, tumour volume > 0.5 cm³, or clinical stage ≥T3). Secondary endpoint compared periprocedural complications. Complications were assessed for 7 days. Results Of 132 patients undergoing PSMA PET/CT, 90 (68%) demonstrated PSMA-avid lesions. Biopsy was positive in 86.7%, with csPCa detected in 75.7%. In the TRUS group ( n = 84), 52 (63%) had positive biopsies, with csPCa in 25 (48.1%). Among patients with non-avid PET lesions ( n = 42), positive TRUS biopsy was seen in 4 (9.5%), with csPCa in 1 (2.4%). Periprocedural pain, hematuria, lower urinary tract symptoms, and infection were significantly lower in the PSMA-guided group (all p < 0.01). Biopsy modality, age, and PSA independently predicted csPCa. csPCa detection rate: PSMA-TB 75.7% and TRUS-GB 48.1%. Conclusions PSMA PET/CT–guided robotic transgluteal biopsy was associated with improved detection of clinically significant prostate cancer and lower periprocedural morbidity as compared with TRUS cognitive fusion biopsy.