Prostate Cancer Clinical Trial
— PROBIOPOfficial 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
Verified date | November 2021 |
Source | Postgraduate Institute of Medical Education and Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 45 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | PGIMER | Chandigarh | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Incidence of procedure related complications | The procedure-related complications in the number and percentage of recruiting participants will be tabulated. | three months |
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