A Phase 2/3 interventional study of PSMA PET guided prostate biopsy and MRI directed TRUS guided prostate biopsy in Prostate Cancer and Prostate Neoplasm, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to male participants aged 45 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 2/3, Interventional, and Diagnostic
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
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 217 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
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
The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.
Procedure: MRI directed TRUS guided prostate biopsy
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
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
Plan to share: Yes
Supporting information: Study protocol
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Post Graduate Institute of Medical Education and Research, Chandigarh