NCT05137561

Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed Cognitive Fusion TRUS Guided Prostate Biopsy (PROBIOP)

Comparison of Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided (Cognitive Fusion) Prostate Biopsy in PIRADS 4 and 5 Lesions: A Pilot Study to Assess Diagnostic Performance and Patient Safety

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: Male
• Age: 45 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy in PIRADS 4/5 lesions.

Detailed description

To compare the diagnostic yield of Robotic-arm assisted 68Ga PSMA PET/CT guided prostate biopsy and MRI directed TRUS guided prostate biopsy in patients with PIRADS grading 4/5. To compare the visual pain index of the patients between two arms during the procedure. To compare the complication rates between the two arms during and after the procedure for a period of 2 weeks

Conditions

• Prostate Cancer
• Prostate Neoplasm

Interventions

Type	Name	Description
PROCEDURE	PSMA PET guided prostate biopsy	PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.
PROCEDURE	MRI directed TRUS guided prostate biopsy	TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring

Timeline

• Start date: 2021-10-25
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2021-11-30
• Last updated: 2025-08-07

Locations

1 site across 1 country: India