LUNAR: a randomized Phase 2 study of

Male Humans Prostatic Neoplasms / pathology Lutetium / therapeutic use Positron Emission Tomography Computed Tomography Quality of Life Neoadjuvant Therapy Androgen Antagonists / therapeutic use Prostate-Specific Antigen Prostatic Neoplasms, Castration-Resistant / pathology Randomized Controlled Trials as Topic Clinical Trials, Phase II as Topic
#ProstateCancer 177Lu-PNT2002 lutetium-177 metastatic hormone-sensitive prostate cancer oligorecurrent progression-free survival prostate cancer prostate-specific membrane antigen stereotactic body radiation therapy trial protocol

Journal

BJU international
ISSN: 1464-410X
Titre abrégé: BJU Int
Pays: England
ID NLM: 100886721

Informations de publication

Date de publication:
07 2023
Historique:
medline: 22 6 2023
pubmed: 17 2 2023
entrez: 16 2 2023
Statut: ppublish

Résumé

To assess the efficacy of The The addition of

Identifiants

DOI: 10.1111/bju.15988 PMID: 36797449
pubmed: 36797449
doi: 10.1111/bju.15988
doi:

Substances chimiques

Lutetium 5H0DOZ21UJ
Androgen Antagonists 0
Prostate-Specific Antigen EC 3.4.21.77

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

65-74

Informations de copyright

© 2023 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.

Références

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Deek MP, Van der Eecken K, Phillips R et al. The mutational landscape of metastatic castration-sensitive prostate cancer: the spectrum theory revisited. Eur Urol 2021; 80: 632-40
Sutera P, Van Der Eecken K, Kishan AU et al. Definitions of disease burden across the spectrum of metastatic castration-sensitive prostate cancer: comparison by disease outcomes and genomics. Prostate Cancer Prostatic Dis 2022; 25: 713-9
Kyriakopoulos CE, Chen YH, Carducci MA et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial. J Clin Oncol 2018; 36: 1080-7
Fizazi K, Tran N, Fein L et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med 2017; 377: 352-60
Hoyle AP, Ali A, James ND et al. Abiraterone in “high-” and “low-risk” metastatic hormone-sensitive prostate cancer. Eur Urol 2019; 76: 719-28
Kawahara T, Yoneyama S, Ohno Y et al. Prognostic value of the LATITUDE and CHAARTED risk criteria for predicting the survival of men with bone metastatic hormone-naïve prostate cancer treated with combined androgen blockade therapy: real-world data from a Japanese multi-institutional study. Biomed Res Int 2020; 2020: 7804932
Gomez DR, Blumenschein GR Jr, Lee JJ et al. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol 2016; 17: 1672-82
Palma DA, Olson R, Harrow S et al. Stereotactic ablative radiotherapy for the comprehensive treatment of oligometastatic cancers: long-term results of the SABR-COMET phase II randomized trial. J Clin Oncol 2020; 38: 2830-8
Ost P, Reynders D, Decaestecker K et al. Surveillance or metastasis-directed therapy for oligometastatic prostate cancer recurrence: a prospective, randomized, multicenter phase II trial. J Clin Oncol 2018; 36: 446-53
Phillips R, Shi WY, Deek M et al. Outcomes of observation vs stereotactic ablative radiation for oligometastatic prostate cancer: the ORIOLE phase 2 randomized clinical trial. JAMA Oncol 2020; 6: 650-9
Siva S, Bressel M, Murphy DG et al. Stereotactic abative body radiotherapy (SABR) for oligometastatic prostate cancer: a prospective clinical trial. Eur Urol 2018; 74: 455-62
Kneebone A, Hruby G, Ainsworth H et al. Stereotactic body radiotherapy for oligometastatic prostate cancer detected via prostate-specific membrane antigen positron emission tomography. Eur Urol Oncol 2018; 1: 531-7
Supiot S, Vaugier L, Pasquier D et al. OLIGOPELVIS GETUG P07, a multicenter phase II trial of combined high-dose salvage radiotherapy and hormone therapy in oligorecurrent pelvic node relapses in prostate cancer. Eur Urol 2021; 80: 405-14
Glicksman RM, Metser U, Vines D et al. Curative-intent metastasis-directed therapies for molecularly-defined oligorecurrent prostate cancer: a prospective phase II trial testing the oligometastasis hypothesis. Eur Urol 2021; 80: 374-82
Bowden P, See AW, Frydenberg M et al. Fractionated stereotactic body radiotherapy for up to five prostate cancer oligometastases: interim outcomes of a prospective clinical trial. Int J Cancer 2020; 146: 161-8
Pasqualetti F, Panichi M, Sainato A et al. [(18)F]choline PET/CT and stereotactic body radiotherapy on treatment decision making of oligometastatic prostate cancer patients: preliminary results. Radiat Oncol 2016; 11: 9
James ND, Sydes MR, Clarke NW et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 2016; 387: 1163-77
Beer TM, Armstrong AJ, Rathkopf DE et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014; 371: 424-33
Deek MP, Yu C, Phillips R et al. Radiation therapy in the definitive management of oligometastatic prostate cancer: the Johns Hopkins experience. Int J Radiat Oncol Biol Phys 2019; 105: 948-56
Deek MP, Taparra K, Dao D et al. Patterns of recurrence and modes of progression after metastasis-directed therapy in oligometastatic castration-sensitive prostate cancer. Int J Radiat Oncol Biol Phys 2021; 109: 387-95
Rowe SP, Gorin MA, Pomper MG. Imaging of prostate-specific membrane antigen with small-molecule PET radiotracers: from the bench to advanced clinical applications. Annu Rev Med 2019; 70: 461-77
Rahbar K, Ahmadzadehfar H, Kratochwil C et al. German multicenter study investigating 177Lu-PSMA-617 radioligand therapy in advanced prostate cancer patients. J Nucl Med 2017; 58: 85-90
Kim YJ, Kim YI. Therapeutic responses and survival effects of 177Lu-PSMA-617 radioligand therapy in metastatic castrate-resistant prostate cancer: a meta-analysis. Clin Nucl Med 2018; 43: 728-34
Hofman MS, Violet J, Hicks RJ et al. [(177)Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Lancet Oncol 2018; 19: 825-33
Hofman MS, Emmett L, Sandhu S et al. [(177)Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. Lancet 2021; 397: 797-804
Sartor O, de Bono J, Chi KN et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med 2021; 385: 1091-103
Violet J, Sandhu S, Iravani A et al. Long-term follow-up and outcomes of retreatment in an expanded 50-patient single-center phase II prospective trial of (177)Lu-PSMA-617 theranostics in metastatic castration-resistant prostate cancer. J Nucl Med 2020; 61: 857-65
Schuchardt C, Zhang J, Kulkarni HR, Chen X, Mueller D, Baum RP. Prostate-specific membrane antigen radioligand therapy using (177)Lu-PSMA I&T and (177)Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer: comparison of safety, biodistribution and dosimetry. J Nucl Med 2021; 63: 1199-207
Deek MP, Van der Eecken K, Sutera P et al. Long-term outcomes and genetic predictors of response to metastasis-directed therapy versus observation in oligometastatic prostate cancer: analysis of STOMP and ORIOLE trials. J Clin Oncol 2022; 40: 3377-82
Benedict SH, Yenice KM, Followill D et al. Stereotactic body radiation therapy: the report of AAPM task group 101. Med Phys 2010; 37: 4078-101
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Auteurs

Ting Martin Ma (TM)

Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
ORCID: 0000-0002-0053-7874

Johannes Czernin (J)

Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

Carol Felix (C)

Department of Radiation Oncology, University of California, Los Angeles, CA, USA.

Rejah Alano (R)

Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.

Holly Wilhalme (H)

Department of Medicine Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

Luca Valle (L)

Department of Radiation Oncology, University of California, Los Angeles, CA, USA.

Michael L Steinberg (ML)

Department of Radiation Oncology, University of California, Los Angeles, CA, USA.

Magnus Dahlbom (M)

Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

Robert E Reiter (RE)

Department of Urology, University of California, Los Angeles, CA, USA.

Matthew B Rettig (MB)

Division of Hematology and Oncology, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

Minsong Cao (M)

Department of Radiation Oncology, University of California, Los Angeles, CA, USA.

Jeremie Calais (J)

Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Physics and Biology in Medicine Interdepartmental Graduate Program, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

Amar U Kishan (AU)

Department of Radiation Oncology, University of California, Los Angeles, CA, USA.
Department of Urology, University of California, Los Angeles, CA, USA.

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questionsmedicales.fr › Maladies urogénitales › Tumeurs de l'appareil urogénital › Tumeurs de l'appareil génital mâle › Tumeurs de la prostate › LUNAR: a randomized Phase 2 study of
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questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › LUNAR: a randomized Phase 2 study of
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questionsmedicales.fr › Maladies urogénitales › Tumeurs de l'appareil urogénital › Tumeurs de l'appareil génital mâle › Tumeurs de la prostate › Tumeurs prostatiques résistantes à la castration › LUNAR: a randomized Phase 2 study of
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questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques de phase II comme sujet › LUNAR: a randomized Phase 2 study of