NCT05137561CompletedPhase 2/3
Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed Cognitive Fusion TRUS Guided Prostate Biopsy (PROBIOP)
Comparison of Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided (Cognitive Fusion) Prostate Biopsy in PIRADS 4 and 5 Lesions: A Pilot Study to Assess Diagnostic Performance and Patient Safety
Source: ClinicalTrials.gov · Last updated 7 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 217 (actual)
- First submitted
- 26 Oct 2021
- Start date
- 25 Oct 2021
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Diseases
- Prostate cancer
- NCT number
- NCT05137561
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 217
- From 25 Oct 2021 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3
Other
- Patients with acute prostatitis/ urine culture positive.
- Patients who refuse to provide the written informed consent
- Non-cooperative patients
Who the study is looking for
- 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
Age in the registry: 45 years to 90 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PGIMER Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.