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

August 4, 2025 updated by: Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chandīgarh
      • Chandigarh, Chandīgarh, India, 160012
        • PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. PIRADS 4 and 5 prostate lesions and PIRADS </= 3 prostate lesions with high clinical suspicion.
  2. 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PSMA PET/CT guided biopsy arm
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
PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.
Active Comparator: MRI directed TRUS guided biopsy
The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.
Procedure: MRI directed TRUS guided prostate biopsy
TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy
Time Frame: 12 months
The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.
12 months
Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy
Time Frame: 12 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of procedure related complications
Time Frame: three months
The procedure-related complications in the number and percentage of recruiting participants will be tabulated.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 27, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK/7840/MD/624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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