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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)
Phase 2, PHASE3 trial testing PSMA PET guided prostate biopsy in Prostate Cancer in 217 participants. Completed in 30 June 2024.
30 June 2024
Quick facts
| Lead sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 217 |
| Start date | 25 October 2021 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across India |
Drugs / interventions tested
- PSMA PET guided prostate biopsy
- MRI directed TRUS guided prostate biopsy
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Prostate Neoplasm — all drugs for Prostate Neoplasm →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05137561
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
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- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Post Graduate Institute of Medical Education and Research, Chandigarh trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05137561 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Post Graduate Institute of Medical Education and Research, Chandigarh
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05137561.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing