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NCT04430192: LuTectomy

Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

Active, enrolled Phase 1, PHASE2 Last updated 8 November 2024
What this trial tests

Phase 1, PHASE2 trial testing 177Lu-PSMA-617 in Prostatic Neoplasms in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
6 August 2020
Primary endpoint
22 December 2022
30 August 2025

Quick facts

Lead sponsorPeter MacCallum Cancer Centre, Australia
PhasePhase 1, PHASE2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date6 August 2020
Primary completion22 December 2022
Estimated completion30 August 2025
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Peter MacCallum Cancer Centre, Australia — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Review of Theranostics: Perspectives on Emerging Approaches and Clinical Advancements.
    Burkett BJ, Bartlett DJ, McGarrah PW, Lewis AR, et al · · 2023 · cited 82× · PMID 37477566 · DOI 10.1148/rycan.220157
  2. Targeted Therapy for Cancers: From Ongoing Clinical Trials to FDA-Approved Drugs.
    Choi HY, Chang JE. · · 2023 · cited 77× · PMID 37686423 · DOI 10.3390/ijms241713618
  3. Status of PSMA-targeted radioligand therapy in prostate cancer: current data and future trials.
    Jang A, Kendi AT, Sartor O. · · 2023 · cited 63× · PMID 36895851 · DOI 10.1177/17588359231157632
  4. Lutetium Lu 177 Vipivotide Tetraxetan: First Approval.
    Keam SJ. · · 2022 · cited 62× · PMID 35553387 · DOI 10.1007/s40291-022-00594-2
  5. Administering [<sup>177</sup>Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study.
    Eapen RS, Buteau JP, Jackson P, Mitchell C, et al · · 2024 · cited 58× · PMID 37891072 · DOI 10.1016/j.eururo.2023.08.026
  6. PSMA Theranostics: Current Landscape and Future Outlook.
    Zhang H, Koumna S, Pouliot F, Beauregard JM, et al · · 2021 · cited 45× · PMID 34439177 · DOI 10.3390/cancers13164023
  7. Recent advances and impending challenges for the radiopharmaceutical sciences in oncology.
    Lapi SE, Scott PJH, Scott AM, Windhorst AD, et al · · 2024 · cited 39× · PMID 38821098 · DOI 10.1016/s1470-2045(24)00030-5
  8. Radionuclide Therapy in Prostate Cancer: from standalone to combination PSMA theranostics.
    Sandhu S, Guo C, Hofman MS. · · 2021 · cited 34× · PMID 34385339 · DOI 10.2967/jnumed.120.243295

Verify or expand the search:

Other trials of 177Lu-PSMA-617

Trials testing the same drug.

Other recruiting trials for Prostatic Neoplasms

Currently open trials in the same condition.

Other Peter MacCallum Cancer Centre, Australia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04430192.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing