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NCT05137561: PROBIOP

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

Completed Phase 2, PHASE3 Last updated 7 August 2025
What this trial tests

Phase 2, PHASE3 trial testing PSMA PET guided prostate biopsy in Prostate Cancer in 217 participants. Completed in 30 June 2024.

Timeline
25 October 2021
Primary endpoint
30 June 2024
30 June 2024

Quick facts

Lead sponsorPost Graduate Institute of Medical Education and Research, Chandigarh
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposediagnostic
Enrollment217
Start date25 October 2021
Primary completion30 June 2024
Estimated completion30 June 2024
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Who can join

Adults 45 to 90, male only, with Prostate Cancer or Prostate Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Role of [<sup>68</sup>Ga]PSMA PET/CT for Clinical Suspicion of Prostate Cancer in Patients with or without Previous Negative Biopsy: A Systematic Review.
    Caracciolo M, Castello A, Urso L, Borgia F, et al · · 2022 · cited 11× · PMID 36291820 · DOI 10.3390/cancers14205036

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Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Post Graduate Institute of Medical Education and Research, Chandigarh trials

Trials by the same sponsor.

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Data sources for this page

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