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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prostate Neoplasm; Prostate Cancer

Treatments: Procedure: MRI directed TRUS guided prostate biopsy; Procedure: PSMA PET guided prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05137561

NK/7840/MD/624

Details and patient eligibility

About

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.

Full description

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

Enrollment: 217 patients

Sex: Male

Ages: 45 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

PSMA PET/CT guided biopsy arm

Active Comparator group

Description:

PSMA PET/CT guided biopsy will be done from PSMA avid lesion of the prostate after reviewing the whole body PSMA PET/CT scan.

Treatment:

Procedure: PSMA PET guided prostate biopsy

MRI directed TRUS guided biopsy

Active Comparator group

Description:

The MRI-directed transrectal ultrasound-guided per-rectal prostate biopsy will be done by cognitive fusion.

Treatment:

Procedure: MRI directed TRUS guided prostate biopsy