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.
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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
217
PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.
TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring
PGIMER
Chandigarh, Chandigarh, India
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 and detection of PCa in both arms
Time frame: 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.
Time frame: 12 months
Incidence of procedure related complications
The procedure-related complications in the number and percentage of recruiting participants will be tabulated.
Time frame: three months
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