PROBIOP: Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided Prostate Biopsy

Sponsor

Postgraduate Institute of Medical Education and Research (Other)

Overall Status

Recruiting

CT.gov ID

NCT05137561

Collaborator

(none)

100

Enrollment

Location

Arms

14.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Neoplasm	Procedure: PSMA PET guided prostate biopsy Procedure: MRI directed TRUS guided prostate biopsy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Simple randomization using RRAppSimple randomization using RRApp

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 25, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy [12 months]
The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis will be tabulated.
Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy [12 months]
The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.

Secondary Outcome Measures

Incidence of procedure related complications [three months]
The procedure-related complications in the number and percentage of recruiting participants will be tabulated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PGIMER	Chandigarh	Chandīgarh	India	160012

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rajender Kumar, Associate Professor, Postgraduate Institute of Medical Education and Research

ClinicalTrials.gov Identifier:

NCT05137561

Other Study ID Numbers:

NK/7840/MD/624

First Posted:

Nov 30, 2021

Last Update Posted:

Nov 30, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Nov 30, 2021