Evidence map›Paper›PMID 38446353›Full record

ArticleMolecular diagnosis & therapy2024

Lutetium-177 Labelled Anti-PSMA Monoclonal Antibody (Lu-TLX591) Therapy for Metastatic Prostate Cancer: Treatment Toxicity and Outcomes.

Hanh Nguyen, Kathryn Hird, Joe Cardaci, Steven Smith, Nat P Lenzo

3 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Molecular diagnosis & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
5.9field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04786847 phase1completednot on this map

A Phase 1 Safety, Tolerability, Biodistribution, Dosimetry and Efficacy Study of 177Lu-DOTA-TLX591 With Best Standard of Care in Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer

TypeinterventionalSponsorTelix Pharmaceuticals (Innovations) Pty LimitedRan2022 to 2023Enrolled30ConditionsMetastatic Prostate CancerArms177Lu-DOTA-TLX591
NCT04876651 phase3terminatednot on this map

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open Label Phase 3 Study With Best Standard of Care With and Without 177Lu-DOTA-rosopatamab for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug

TypeinterventionalSponsorTelix Pharmaceuticals (Innovations) Pty LtdRan2023 to 2025Enrolled16ConditionsMetastatic Prostate CancerArms177Lu-DOTA-rosopatamb, Standard of Care
NCT05146973 phase2completednot on this map

A Single Arm, Phase 2 Trial of External Beam Radiation Therapy (EBRT) in Combination With 177Lu-DOTA-TLX591-CHO in Patients With Biochemically Recurrent Oligometastatic, Prostate Specific Membrane Antigen-Expressing Prostate Cancer

TypeinterventionalSponsorTelix Pharmaceuticals (Innovations) Pty LimitedRan2022 to 2024Enrolled5ConditionsProstate CancerArms177Lu-DOTA-TLX591
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Challenges and Opportunities in Radioligand Therapy.Journal of nuclear medicine technology · 2025
    Review
  7. Enhancing safety: Multi-institutional FMEA and FTA onJournal of applied clinical medical physics · 2025
    Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Hanh NguyenSchool of Medicine, Fremantle Campus, The University of Notre Dame, Fremantle, WA, Australia. hanh.nguyen@health.wa.gov.au.ORCID 0000-0003-2747-5295
Kathryn HirdSchool of Medicine, Fremantle Campus, The University of Notre Dame, Fremantle, WA, Australia.
Joe CardaciSchool of Medicine, Fremantle Campus, The University of Notre Dame, Fremantle, WA, Australia.
Steven SmithGenesiscare, Murdoch, WA, Australia.
Nat P LenzoSchool of Medicine, Fremantle Campus, The University of Notre Dame, Fremantle, WA, Australia.
The University of Notre Dame Australia · AUMurdoch University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWhilst prostate cancer is the fourth most common cancer globally, effective therapies for patients with advanced disease are lacking. In recent years, interest in using theranostic agents to treat castrate-resistant prostate cancer (CRPC) and metastatic prostate cancer has emerged. Lu-TLX591 monoclonal antibody is a potential agent of significance; however, to date, reports on its toxicity and efficacy have been limited to small clinical trials in heavily pretreated patients. This retrospective study describes the real-world toxicity and efficacy profile of Lu-TLX591.

methodsEighteen patients received Lu-TLX591 at two private oncology centres in Australia. Patients were eligible if they had CRPC or metastatic prostate cancer and prostate-specific membrane antigen (PSMA)-avid disease confirmed by PSMA-positron emission tomography (PET). Patients received two cycles of Lu-TLX591 monoclonal antibody (177 Lu-DOTA-rosopatamab) each dosed from 1.01-2.85 GBq, 14 days apart. Patient side effects, blood test results and radiology reports were recorded on the patient's electronic medical record (eMR).

resultsProminent side effects included fatigue (55.6%), anorexia (16.7%), nausea (11.1%), and transfusion reactions (11.1%). All-grade haematological toxicities included lymphopenia (61.1%), anaemia (22.2%), leukopenia (27.8%), neutropenia (27.8%), and thrombocytopenia (27.8%). Grade 4 toxicity included lymphopenia (6.7%) and thrombocytopenia (6.7%). Patients' prostate-specific antigen (PSA) responses were as follows; ≥ 30% PSA decline (27.8%), ≥ 50% PSA decline (11.4%) and any PSA decline (38.9%). Follow-up radiology revealed 54.5% stable disease, 45.4% disease progression and 9.1% disease regression.

conclusionLu-TLX591 was safely administered at acceptable toxicity and its efficacy reflects previous clinical trials. Larger studies are required and are underway (NCT04786847; NCT05146973; NCT04876651) to determine Lu-TLX591 effectiveness amongst different prostate cancer populations and compare its efficacy against peptide-based radiopharmaceutical agents.

Indexed as

Antibodies, MonoclonalLutetiumRadioisotopesAgedAged, 80 and overAntigens, SurfaceGlutamate Carboxypeptidase IIHumansMaleMiddle AgedNeoplasm MetastasisProstate-Specific AntigenProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantRadiopharmaceuticalsRetrospective StudiesAntibodies, MonoclonalAntigens, SurfaceFOLH1 protein, humanGlutamate Carboxypeptidase IILutetiumLutetium-177Prostate-Specific AntigenRadioisotopesRadiopharmaceuticals

Identifiers

PMID38446353
PMCPMC11068829
OpenAlexW4392519240

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.