Sequential [

Journal

The Lancet. Oncology
ISSN: 1474-5488
Titre abrégé: Lancet Oncol
Pays: England
ID NLM: 100957246

Informations de publication

Date de publication:
13 Sep 2024
Historique:
received: 09 07 2024
revised: 31 07 2024
accepted: 31 07 2024
medline: 19 9 2024
pubmed: 19 9 2024
entrez: 18 9 2024
Statut: aheadofprint

Résumé

Lutetium-177 [ UpFrontPSMA was an investigator-initiated, multicentre, open-label, randomised, phase 2 trial done at 11 Australian hospitals. Eligible patients had prostate adenocarcinoma without clinically significant neuroendocrine differentiation or small-cell histology, were aged 18 years or older, had less than 4 weeks on androgen deprivation therapy, had an Eastern Cooperative Oncology Group performance status of 0-2, and had high-volume PSMA-avid disease on [ Between May 5, 2020, and April 18, 2023, 130 patients were randomly assigned, 63 (48%) to [ [ Prostate Cancer Research Alliance (Movember Foundation and Australian Government Medical Research Future Fund), US Department of Defence Impact Award-Clinical Trials, Endocyte/Advanced Accelerator Applications (a Novartis company), Australian Nuclear Science and Technology Organization, Victorian Cancer Agency, University of Melbourne, and Peter MacCallum Cancer Foundation.

Sections du résumé

BACKGROUND BACKGROUND
Lutetium-177 [
METHODS METHODS
UpFrontPSMA was an investigator-initiated, multicentre, open-label, randomised, phase 2 trial done at 11 Australian hospitals. Eligible patients had prostate adenocarcinoma without clinically significant neuroendocrine differentiation or small-cell histology, were aged 18 years or older, had less than 4 weeks on androgen deprivation therapy, had an Eastern Cooperative Oncology Group performance status of 0-2, and had high-volume PSMA-avid disease on [
FINDINGS RESULTS
Between May 5, 2020, and April 18, 2023, 130 patients were randomly assigned, 63 (48%) to [
INTERPRETATION CONCLUSIONS
[
FUNDING BACKGROUND
Prostate Cancer Research Alliance (Movember Foundation and Australian Government Medical Research Future Fund), US Department of Defence Impact Award-Clinical Trials, Endocyte/Advanced Accelerator Applications (a Novartis company), Australian Nuclear Science and Technology Organization, Victorian Cancer Agency, University of Melbourne, and Peter MacCallum Cancer Foundation.

Identifiants

DOI: 10.1016/S1470-2045(24)00440-6 PMID: 39293461
pubmed: 39293461
pii: S1470-2045(24)00440-6
doi: 10.1016/S1470-2045(24)00440-6
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04343885']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Investigateurs

T Akhurst (T)
R Alipour (R)
L Au (L)
P Banks (P)
B Emerson (B)
N Hussain (N)
M Haskali (M)
J Lewin (J)
R Linklater (R)
L Kostos (L)
R Kashyap (R)
P Krishanth (P)
G Kong (G)
A Kumar (A)
D Murphy (D)
P Roselt (P)
S Sandhu (S)
M Scalzo (M)
B Tran (B)
R Wallace (R)
L Spain (L)
H Bourke (H)
A Milton (A)
D Russo (D)
M Bills (M)
C Chew (C)
W Hsieh (W)
B Crouch (B)
D Smyth (D)
S Pandelus (S)
H Lam (H)
C Gan (C)
J Goh (J)
A Scott (A)
U Hafeez (U)
U Ackermann (U)
K Young (K)
A Poon (A)
K Pathmaraj (K)
G Schembri (G)
P Roach (P)
D Bailey (D)
T Hung (T)
A Asad (A)
T Hagan (T)
J Watts (J)
E Campbell (E)
W Chua (W)
A Pal (A)
M Crumbaker (M)
A Nguyen (A)
A Yam (A)
J Chen (J)
L Ardolino (L)
K Kongrak (K)
L Ratnayake (L)

Informations de copyright

Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

Déclaration de conflit d'intérêts

Declaration of interests AAA reports grants from Aptevo Therapeutics (institutional), Astellas (investigator), Astellas (institutional), AstraZeneca (institutional), AstraZeneca (investigator), Bionomics (institutional), Bristol Myers Squibb (institutional), Eli Lilly (institutional), Exelixis (institutional), Gilead Sciences (institutional), GlaxoSmithKline (institutional), Hinova (institutional), Ipsen (institutional), Janssen (institutional), MedImmune (institutional), Merck Serono (investigator), Merck Serono (institutional), Merck Sharpe & Dohme (institutional), Novartis (institutional), Pfizer (institutional), Sanofi Aventis (institutional), and SYNthorx (institutional); consulting fees from Astellas, Novartis, Janssen, Sanofi, AstraZeneca, Bristol Myers Squibb, Tolmar, Telix Pharma, Merck, Bayer, Ipsen, Merck Serono, Amgen, and Noxopharm; honoraria from Janssen, Astellas, Novartis, Tolmar, Amgen, Pfizer, Bayer, Telix Pharma, Bristol Myers Squibb, Merck Serono, AstraZeneca, Sanofi, Ipsen, Merck Sharp & Dohme, Noxopharm, Daiichi Sankyo, and Arvinas; speakers' bureau fees from Astellas, Novartis, Amgen, Bayer, Janssen, Ipsen, Bristol Myers Squibb, and Merck Serono; support for attending meetings from Amgen, Astellas, Bayer, Hinova, Janssen, Merck Serono, Novartis, Pfizer, and Tolmar; participation on data safety monitoring or advisory boards for Arvinas, Astellas, Novartis, Janssen, Sanofi, AstraZeneca, Bristol Myers Squibb, Tolmar, Telix Pharma, Merck Sharpe & Dohme, Bayer, Ipsen, Merck Serono, Amgen, Noxopharm, and Daiichi Sankyo. MV reports personal fees from AstraZeneca and Merck Sharpe & Dohme and grants (to their institution) from AstraZeneca, Merck Sharpe & Dohme, Alpine Immune Sciences, Virocure, Hinova, Atridia/Hengrui, Antengene, and Biogene. AJW declares grants to their institution from Merck Sharpe & Dohme; consulting fees from Merck Sharpe & Dohme, Bayer, Bristol Myers Squibb, Pfizer, Ipsen, and Astellas; honoraria from Astellas and Bristol Myers Squibb; and support for attending meetings from Bayer. AG reports grants from Sun Pharma; consulting fees from Regeneron and Bayer; support to attend meetings from Sun Pharma and Bristol Myers Squibb; and participation in a data safety monitoring or advisory board for Regeneron and Bayer. RJF reports committee involvement in the Australasian Radiopharmaceutical Trials Network (unpaid). LE reports research grant support (to their institution) from Novartis and Clarity Pharma; consulting fees for lectures or advisory boards from Astellas, Janssen, AstraZeneca, Clarity, Novartis, and Telix in the past 5 years; and philanthropic grant support from the Prostate Cancer Foundation, St Vincent's Clinic Research Foundation, and the Curran Foundation. DGM has received reimbursement for advisory board or speaker bureau activity from the following companies (in the past 36 months): Janssen, Astellas, Bayer, AstraZeneca, Mundipharma, Novartis, and Ipsen. AR has received reimbursement for advisory board or speaker bureau activity from the following companies: AstraZeneca, Daiichi Sankyo, Lily, Pfizer, Merck Sharpe & Dohme, Roche, and Novartis. DAP reports personal fees from Eisai. MSH reports grants and receipt of equipment, materials, drugs, medical writing, gifts, or other services from the Prostate Cancer Foundation, NHRMC, Movember, US Department of Defense, Medical Research Future Fund, Bayer, Peter MacCallum Foundation, Isotopia, and the Australian Nuclear Science and Technology Organisation; consulting fees from Merck Sharp & Dohme and Novartis; honoraria from Janssen, Novartis, and AstraZeneca; and support for meetings from Merck Sharp & Dohme, Novartis, Janssen, AstraZeneca, and Astellas. All other authors declare no competing interests.

Auteurs

Arun A Azad (AA)

Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. Electronic address: arun.azad@petermac.org.

Mathias Bressel (M)

Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.

Hsiang Tan (H)

Department of Medical Oncology, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA, Australia.

Mark Voskoboynik (M)

Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia; School of Translational Medicine, Monash University, Melbourne, VIC, Australia.

Aneta Suder (A)

Department of Medical Oncology, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.

Andrew J Weickhardt (AJ)

Olivia Newton-John Cancer and Wellness Centre, Austin Health, Melbourne, VIC, Australia; School of Cancer Medicine, La Trobe University, Melbourne, VIC, Australia.

Alexander Guminski (A)

Department of Medical Oncology, Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia.

Roslyn J Francis (RJ)

Department of Nuclear Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia; Medical School, University of Western Australia, Perth, WA, Australia.

Javad Saghebi (J)

Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.

Nattakorn Dhiantravan (N)

Department of Nuclear Medicine and Specialised PET Services, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.

Anthony M Joshua (AM)

Department of Medical Oncology, Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, NSW, Australia; Garvan Institute of Medical Research, Sydney, NSW, Australia.

Louise Emmett (L)

Garvan Institute of Medical Research, Sydney, NSW, Australia; Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, NSW, Australia; St Vincent's Clinical School, University of New South Wales, Sydney, NSW, Australia.

Lisa Horvath (L)

Department of Medical Oncology, Chris O'Brien Lifehouse, Sydney, NSW, Australia; Central Clinical School, University of Sydney, Sydney, NSW, Australia.

Declan G Murphy (DG)

Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.

Edward Hsiao (E)

Department of Nuclear Medicine and PET, Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia.

Bavanthi Balakrishnar (B)

Department of Medical Oncology, Liverpool Hospital, Sydney, NSW, Australia.

Peter Lin (P)

Department of Nuclear Medicine and PET, Liverpool Hospital, Sydney, NSW, Australia.

Andrew Redfern (A)

Medical School, University of Western Australia, Perth, WA, Australia; Department of Medical Oncology, Fiona Stanley Hospital, Perth, WA, Australia.

William Macdonald (W)

Medical School, University of Western Australia, Perth, WA, Australia; Department of Nuclear Medicine, Fiona Stanley Hospital, Perth, WA, Australia.

Siobhan Ng (S)

Department of Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia; Department of Oncology, University of Western Australia, Perth, WA, Australia.

Sze-Ting Lee (ST)

Department of Medicine, University of Melbourne, Melbourne, VIC, Australia; Department of Surgery, University of Melbourne, Melbourne, VIC, Australia; Department of Molecular Imaging and Therapy, Austin Health, Melbourne, VIC, Australia; School of Cancer Medicine, La Trobe University, Melbourne, VIC, Australia.

David A Pattison (DA)

Department of Nuclear Medicine and Specialised PET Services, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia; School of Medicine, University of Queensland, Brisbane, QLD, Australia.

David Nadebaum (D)

Department of Nuclear Medicine and PET, Alfred Health, Melbourne, VIC, Australia.

Ian D Kirkwood (ID)

Department of Nuclear Medicine and PET, Royal Adelaide Hospital, Adelaide, SA, Australia; Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, SA, Australia.

Michael S Hofman (MS)

Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.

Classifications MeSH