Related Experiment Video
Updated: Jun 20, 2026
A Cognitive Fusion-guided Prostate Biopsy Using Multiparametric Magnetic Resonance Imaging and Transrectal Ultrasound
Published on: March 21, 2025
PCa Detection in PI-RADS 4 and 5 Lesions: Comparison of [68Ga]Ga-PSMA-11 PET/CT-Guided Robot-Assisted Biopsy Versus
Rajender Kumar1, Aravindh Ram2, Santosh Kumar3
1Department of Nuclear Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India; drrajender2010@gmail.com.
Abstract:
Lesions with a Prostate Imaging-Reporting and Data System (PI-RADS) score of 4 or greater on multiparametric MRI (mpMRI) indicate a high likelihood of prostate cancer (PCa), and guidelines recommend a targeted biopsy. We aimed to compare the diagnostic performance of robotic arm-assisted [68Ga]Ga-PSMA-11 PET/CT-guided prostate biopsy (PGPB) with mpMRI-directed cognitive-fusion transrectal ultrasound-guided biopsy (MCFB) in biopsy-naïve men with clinical findings suggestive of PCa. Methods: This prospective, single-center, randomized clinical trial (NCT05137561) enrolled biopsy-naïve men age 50-90 y with elevated levels of prostate-specific antigen (≥4 ng/mL) and abnormal digital rectal examination findings. All participants underwent mpMRI, and those with a PI-RADS score of 4 or greater were randomized into 2 arms. In arm 1, participants underwent PGPB for a [68Ga]Ga-PSMA-avid lesion, and participants in arm 2 underwent MCFB. Participants in arm 1 with PET-negative findings subsequently underwent MCFB, and participants with negative biopsy results underwent PET and PGPB. The primary outcome was the detection of PCa. Secondary outcomes included complication rates and participant-reported pain. Result: Of the 267 participants enrolled, 81.3% (217) had lesions with a PI-RADS score of 4 or greater and were randomized to either PGPB (n = 112) or MCFB (n = 105). PCa was detected in 97.1% of participants (101/104) in arm 1 and 81.0% (85/105) in arm 2 (P < 0.05). PGPB showed higher diagnostic accuracy for PI-RADS 5 lesions (100% vs. 95.1%, P = 0.09). Major complications were observed in arm 2 only (n = 5). Arm 1 had significantly fewer complications (10.8% vs. 51.4%, P < 0.01), a lower median visual analog scale score for pain (3 vs. 5), and shorter procedure times. The core positivity rate was higher in arm 1 (60% ± 20%), despite obtaining fewer cores. Conclusion: [68Ga]Ga-PSMA-11 PGPB demonstrated higher diagnostic performance, fewer complications, and better tolerability compared with MCFB. This approach enables integrated diagnosis and staging, offering a promising alternative for efficient, safe, and accurate evaluation of prostate cancer.
Insights
Robotic arm-assisted [68Ga]Ga-PSMA-11 PET/CT-guided prostate biopsy (PGPB) offers superior prostate cancer (PCa) detection rates and fewer complications compared to MRI-directed cognitive-fusion biopsy (MCFB). This advanced technique provides a safer, more accurate evaluation for biopsy-naïve men.
Area of Science:
- Urology
- Radiology
- Nuclear Medicine
Background:
- Multiparametric MRI (mpMRI) with PI-RADS score ≥4 indicates high likelihood of prostate cancer (PCa), necessitating targeted biopsy.
- Current guidelines recommend targeted biopsy for suspicious lesions identified via mpMRI.
- Biopsy-naïve men with clinical findings suggestive of PCa require accurate diagnostic methods.
Purpose of the Study:
- To compare the diagnostic performance of robotic arm-assisted [68Ga]Ga-PSMA-11 PET/CT-guided prostate biopsy (PGPB) versus mpMRI-directed cognitive-fusion transrectal ultrasound-guided biopsy (MCFB).
- To evaluate complication rates and patient-reported pain associated with each biopsy technique.
- To assess the efficacy of PGPB in detecting PCa in biopsy-naïve men.
Main Methods:
- Prospective, single-center, randomized clinical trial (NCT05137561) involving biopsy-naïve men aged 50-90 with PSA ≥4 ng/mL and abnormal DRE.
- Participants with PI-RADS ≥4 on mpMRI were randomized to PGPB (n=112) or MCFB (n=105).
- Primary outcome: PCa detection. Secondary outcomes: complication rates, pain scores, procedure times.
Main Results:
- PCa detection rate was significantly higher with PGPB (97.1%) compared to MCFB (81.0%) (P < 0.05).
- PGPB demonstrated higher diagnostic accuracy for PI-RADS 5 lesions (100% vs. 95.1%).
- PGPB group experienced fewer complications (10.8% vs. 51.4%), lower pain scores (median 3 vs. 5), and shorter procedure times.
Conclusions:
- [68Ga]Ga-PSMA-11 PGPB offers superior diagnostic performance, enhanced safety, and better tolerability over MCFB for biopsy-naïve men.
- PGPB facilitates integrated diagnosis and staging, representing a promising alternative for efficient prostate cancer evaluation.
- The study highlights PGPB as a safe and accurate method for evaluating prostate cancer, improving patient outcomes.
