Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided Prostate Biopsy (PROBIOP)
Primary Purpose
Prostate Cancer, Prostate Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
PSMA PET guided prostate biopsy
MRI directed TRUS guided prostate biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- PGIMERRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PSMA PET/CT guided biopsy arm
MRI directed TRUS guided biopsy
Arm Description
PSMA PET/CT guided biopsy will be done from PSMA avid lesion of the prostate after reviewing the whole body PSMA PET/CT scan.
The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Incidence of procedure related complications
The procedure-related complications in the number and percentage of recruiting participants will be tabulated.
Full Information
NCT ID
NCT05137561
First Posted
October 26, 2021
Last Updated
November 27, 2021
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT05137561
Brief Title
Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided Prostate Biopsy
Acronym
PROBIOP
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Simple randomization using RRApp
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSMA PET/CT guided biopsy arm
Arm Type
Active Comparator
Arm Description
PSMA PET/CT guided biopsy will be done from PSMA avid lesion of the prostate after reviewing the whole body PSMA PET/CT scan.
Arm Title
MRI directed TRUS guided biopsy
Arm Type
Active Comparator
Arm Description
The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.
Intervention Type
Procedure
Intervention Name(s)
PSMA PET guided prostate biopsy
Intervention Description
PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.
Intervention Type
Procedure
Intervention Name(s)
MRI directed TRUS guided prostate biopsy
Intervention Description
TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring
Primary Outcome Measure Information:
Title
Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy
Description
The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis will be tabulated.
Time Frame
12 months
Title
Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy
Description
The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of procedure related complications
Description
The procedure-related complications in the number and percentage of recruiting participants will be tabulated.
Time Frame
three months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer is malignancy of the male prostate.
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
PGIMER
City
Chandigarh
State/Province
Chandīgarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajender Kumar, MD
Phone
+91-9216605341
Email
drrajender2010@gmail.com
First Name & Middle Initial & Last Name & Degree
Aravindh Ramalingam, MBBS
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided Prostate Biopsy
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