Clinical Trial Protocol for VIOLET: A Single-Center, Phase I/II Trial Evaluation of Radioligand Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer with [161Tb]Tb-PSMA-I&amp;T

James P. Buteau; Louise Kostos; Ramin Alipour; Price Jackson; Lachlan McInstosh; Brittany Emmerson; Mohammad B. Haskali; Jing Xie; Elizabeth Medhurst; Rajeev Ravi; Brian D. Gonzalez; Heidi Fettke; Benjamin Blyth; Luc Furic; Katie Owen; Shahneen Sandhu; Declan G. Murphy; Arun A. Azad; Michael S. Hofman

doi:10.2967/jnumed.124.267650

Research ArticleClinical Investigation

Clinical Trial Protocol for VIOLET: A Single-Center, Phase I/II Trial Evaluation of Radioligand Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer with [¹⁶¹Tb]Tb-PSMA-I&T

James P. Buteau, Louise Kostos, Ramin Alipour, Price Jackson, Lachlan McInstosh, Brittany Emmerson, Mohammad B. Haskali, Jing Xie, Elizabeth Medhurst, Rajeev Ravi, Brian D. Gonzalez, Heidi Fettke, Benjamin Blyth, Luc Furic, Katie Owen, Shahneen Sandhu, Declan G. Murphy, Arun A. Azad and Michael S. Hofman

Journal of Nuclear Medicine August 2024, 65 (8) 1231-1238; DOI: https://doi.org/10.2967/jnumed.124.267650

James P. Buteau

1Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

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Louise Kostos

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

3Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

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Ramin Alipour

1Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

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Price Jackson

1Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

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Lachlan McInstosh

1Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

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Brittany Emmerson

1Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

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Mohammad B. Haskali

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

4Radiopharmaceutical Production and Research Laboratory, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

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Jing Xie

5Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

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Elizabeth Medhurst

1Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

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Rajeev Ravi

6Department of Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

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Brian D. Gonzalez

7Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida;

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Heidi Fettke

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

8Cancer Research Division, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; and

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Benjamin Blyth

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

8Cancer Research Division, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; and

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Luc Furic

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

8Cancer Research Division, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; and

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Katie Owen

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

8Cancer Research Division, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; and

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Shahneen Sandhu

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

3Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

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Declan G. Murphy

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

9Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

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Arun A. Azad

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

3Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

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Michael S. Hofman

1Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia;

2Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia;

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Vol. 65, Issue 8

August 1, 2024

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Clinical Trial Protocol for VIOLET: A Single-Center, Phase I/II Trial Evaluation of Radioligand Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer with [¹⁶¹Tb]Tb-PSMA-I&T

Journal of Nuclear Medicine Aug 2024, 65 (8) 1231-1238; DOI: 10.2967/jnumed.124.267650

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Clinical Trial Protocol for VIOLET: A Single-Center, Phase I/II Trial Evaluation of Radioligand Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer with [¹⁶¹Tb]Tb-PSMA-I&T

Journal of Nuclear Medicine Aug 2024, 65 (8) 1231-1238; DOI: 10.2967/jnumed.124.267650

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Keywords

prostate cancer
PSMA
161Tb
Auger electrons
theranostics

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