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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Prostate Cancer, Prostate Neoplasm

Intervention / Treatment
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* Procedure: PSMA PET guided prostate biopsy
* Procedure: MRI directed TRUS guided prostate biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Simple randomization using RRApp
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 will be tabulated. | 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 Outcome Measures

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