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

NCT05137561 | Completed Phase 2

• 1 other identifier: NK/7840/MD/624
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Prostate Neoplasm

Outcome Measures

Primary Outcomes (2)

• Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy

  The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis and detection of PCa in both arms

  12 months

• Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy

  The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.

  12 months

Secondary Outcomes (1)

• Incidence of procedure related complications

  three months

Study Arms (2)

PSMA PET/CT guided biopsy arm

ACTIVE COMPARATOR

PSMA PET/CT guided biopsy will be done from PSMA avid lesion of the prostate after reviewing the whole body PSMA PET/CT scan.

Procedure: PSMA PET guided prostate biopsy

MRI directed TRUS guided biopsy

ACTIVE COMPARATOR

The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.

Procedure: MRI directed TRUS guided prostate biopsy

Interventions

PSMA PET guided prostate biopsy PROCEDURE

PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.

PSMA PET/CT guided biopsy arm

MRI directed TRUS guided prostate biopsy PROCEDURE

TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring

MRI directed TRUS guided biopsy

Eligibility Criteria

• Age: 45 Years - 90 Years
• Gender Eligibility Details: Prostate cancer is malignancy of the male prostate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PIRADS 4 and 5 prostate lesions and PIRADS \</= 3 prostate lesions with high clinical suspicion.
• Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp

You may not qualify if:

• Patients with acute prostatitis/ urine culture positive.
• Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3
• Patients who refuse to provide the written informed consent
• Non-cooperative patients

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Model Details: Simple randomization using RRApp

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 30, 2021
• Study Start: October 25, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IN (1)