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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSMA PET/CT guided biopsy arm | Active Comparator | PSMA PET/CT guided biopsy will be done from PSMA avid lesion of the prostate after reviewing the whole body PSMA PET/CT scan. |
|
| MRI directed TRUS guided biopsy | Active Comparator | The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA PET guided prostate biopsy | Procedure | PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done. |
|
| 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 and detection of PCa in both arms | 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 |
| 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 |
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Inclusion Criteria:
Prostate cancer is malignancy of the male prostate.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | Chandigarh | 160012 | India |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 9, 2025 | |
| Reset | Dec 18, 2025 |
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Simple randomization using RRApp
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| MRI directed TRUS guided prostate biopsy | Procedure | TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 9, 2025 | Dec 18, 2025 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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