CompletedPhase 2/3

Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed Cognitive Fusion TRUS Guided Prostate Biopsy (PROBIOP)

India217 participantsStarted 2021-10-25

Plain-language 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 in PIRADS 4/5 lesions.

Who can participate

Age range45 Years – 90 Years

SexMALE

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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

What they're measuring

Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy

Timeframe: 12 months

Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy

Timeframe: 12 months

Trial details

NCT IDNCT05137561

SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

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