Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial

Conception and design: Phuoc T. Tran, Arthur Y. Hung, Matthew P. Deek, Mark Markowski, Michael Carducci, Mario Eisenberger Theodore L. DeWeese, Hao Wang, Emmanuel S. Antonarakis

Financial support: Phuoc T. Tran

Administrative support: Phuoc T. Tran, Stephen Greco

Provision of study materials or patients: Phuoc T. Tran, Daniel Y. Song, Arthur Y. Hung, Jason W.D. Hearn, Tamara Lotan, Shirl Dipasquale, Samuel Denmeade, Michael Carducci, Elai Davicioni, Stanley L. Liauw, Elisabeth I. Heath, Daniel E. Spratt, Tomasz M. Beer, Emmanuel S. Antonarakis

Collection and assembly of data: Phuoc T. Tran, Kathryn Lowe, Daniel Y. Song, Arthur Y. Hung, Jason W.D. Hearn, Steven Miller, Tamara Lotan, Catherine H. Marshall, Shirl Dipasquale, Samuel Denmeade, Michael Carducci, Matthew Orton, Curtiland Deville, Elai Davicioni, Stanley L. Liauw, Stephen Greco, Neil B. Desai, Daniel E. Spratt, Felix Feng, Tomasz M. Beer, Emmanuel S. Antonarakis

Data analysis and interpretation: Phuoc T. Tran, Hua-Ling Tsai, Daniel Y. Song, Arthur Y. Hung, Jason W.D. Hearn, James A. Proudfoot, Matthew P. Deek, Ryan Phillips, Channing J. Paller, Catherine H. Marshall, Mark Markowski, Michael Carducci, Mario Eisenberger Theodore L. DeWeese, Curtiland Deville, Elai Davicioni, Elisabeth I. Heath, Felix Feng, Hao Wang, Tomasz M. Beer, Emmanuel S. Antonarakis

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Phuoc T. Tran

This author is a member of the Journal of Clinical Oncology Editorial Board. Journal policy recused the author from having any role in the peer review of this manuscript.

Honoraria: Reflexion Medical

Consulting or Advisory Role: Astellas Pharma, Regeneron, GenomeDx, Reflexion Medical, Dendreon, Noxopharm, Janssen, Myovant Sciences, AstraZeneca, Bayer Health

Research Funding: Astellas Pharma (Inst), Reflexion Medical (Inst), Bayer Health (Inst)

Patents, Royalties, Other Intellectual Property: Compounds and Methods of Use in Ablative Radiotherapy. Patent filed 3/9/2012. PCT/US2012/028475. PCT/WO/2012/122471

Travel, Accommodations, Expenses: Reflexion Medical

Daniel Y. Song

Consulting or Advisory Role: Isoray, BioProtect

Research Funding: Candel Therapeutics, BioProtect

Arthur Y. Hung

Research Funding: Janssen Oncology (Inst)

Jason W.D. Hearn

Consulting or Advisory Role: The Dedham Group

James A. Proudfoot

Employment: Veracyte

Stock and Other Ownership Interests: Veracyte

Ryan Phillips

Uncompensated Relationships: Veracyte

Tamara Lotan

Consulting or Advisory Role: Janssen Oncology

Research Funding: Ventana Medical Systems, DeepBio, AIRA Matrix (Inst), Exact Sciences

Channing J. Paller

Consulting or Advisory Role: Dendreon, Omnitura, Exelixis

Research Funding: Lilly (Inst)

Catherine H. Marshall

This author is a member of the Journal of Clinical Oncology Editorial Board. Journal policy recused the author from having any role in the peer review of this manuscript.

Consulting or Advisory Role: McGraw-Hill Education, Dendreon, Bayer, Obseva

Patents, Royalties, Other Intellectual Property: McGraw Hill—textbook royalties

Travel, Accommodations, Expenses: Bayer

Mark Markowski

Honoraria: Clovis Oncology, Exelixis

Samuel Denmeade

Research Funding: Astellas Pharma (Inst)

Patents, Royalties, Other Intellectual Property: Patent licensed to Pfizer receive patent maintenance fees

Michael Carducci

This author is an Associate Editor for Journal of Clinical Oncology. Journal policy recused the author from having any role in the peer review of this manuscript.

Consulting or Advisory Role: Pfizer, Exelixis, Acrivon, AstraZeneca, Sanofi

Research Funding: Pfizer (Inst), Arcus Biosciences (Inst), Merck (Inst), Celgene/Bristol Myers Squibb (Inst)

Mario Eisenberger

Leadership: Veru

Stock and Other Ownership Interests: Veru

Honoraria: Merck Sharp & Dohme, Bristol Myers Squibb, Seattle Genetics, Bayer

Travel, Accommodations, Expenses: Veru

Theodore L. DeWeese

Stock and Other Ownership Interests: Digital Harmonic

Patents, Royalties, Other Intellectual Property: patent pending on computer algorithm in radiation therapy planning

Curtiland Deville

Consulting or Advisory Role: Blue Earth Diagnostics, AstraZeneca

Elai Davicioni

Employment: GenomeDx, Decipher Biosciences, Veracyte

Leadership: GenomeDx, Decipher Biosciences, Veracyte

Stock and Other Ownership Interests: GenomeDx, Decipher Biosciences, Veracyte

Patents, Royalties, Other Intellectual Property: Cancer Diagnostics Using Biomarkers 20140066323

Travel, Accommodations, Expenses: GenomeDx, Veracyte

Elisabeth I. Heath

Honoraria: Bayer, Seattle Genetics, Sanofi, AstraZeneca, ECOR1 Capital, Genzyme, Janssen, MJH Healthcare Holdings, LLC, Team 9, Vereo Communications, HSC Acquisition, Astellas Pharma, Caris Life Sciences, Johnson & Johnson/Janssen

Consulting or Advisory Role: Bayer, Sanofi, AstraZeneca, Astellas Pharma, Bristol Myers Squibb, Janssen, Seattle Genetics

Speakers' Bureau: Sanofi

Research Funding: Tokai Pharmaceuticals (Inst), Seattle Genetics (Inst), Agensys (Inst), Dendreon (Inst), Genentech/Roche (Inst), Millennium (Inst), Celldex (Inst), Inovio Pharmaceuticals (Inst), Celgene (Inst), Merck (Inst), AstraZeneca (Inst), Esanik (Inst), Zenith Epigenetics (Inst), Oncolys BioPharma (Inst), Curemeta (Inst), Bristol Myers Squibb (Inst), eFFECTOR Therapeutics (Inst), Fortis (Inst), Astellas Pharma (Inst), Medivation (Inst), Ignyta (Inst), Synta (Inst), Caris Life Sciences (Inst), Boehringer Ingelheim (Inst), GlaxoSmithKline (Inst), Merck Sharp & Dohme (Inst), Plexxikon (Inst), Corcept Therapeutics (Inst), Infinity Pharmaceuticals (Inst), Bayer (Inst), Modra Pharmaceuticals (Inst), Pellficure (Inst), Champions Oncology (Inst), AIQ Solutions (Inst), Novartis (Inst), Janssen Research & Development (Inst), Mirati Therapeutics (Inst), Peloton Therapeutics (Inst), Daiichi Sankyo Inc (Inst), Calibr (Inst), Eisai (Inst), Pharmacyclics (Inst), Five Prime Therapeutics (Inst), Arvinas (Inst), BioXCel therapeutics (Inst), Calithera Biosciences (Inst), Corvus Pharmaceuticals (Inst), Exelixis (Inst), Gilead Sciences (Inst), Harpoon therapeutics (Inst), Roche (Inst), ITeos Therapeutics (Inst), Pfizer (Inst), POINT Biopharma (Inst)

Travel, Accommodations, Expenses: Caris Life Sciences

Other Relationship: Caris Centers of Excellence

Neil B. Desai

Consulting or Advisory Role: Boston Scientific

Speakers' Bureau: Ultimate Medical Academy

Research Funding: Boston Scientific

Travel, Accommodations, Expenses: Boston Scientific

Uncompensated Relationships: Bayer, Janssen Oncology

Open Payments Link: https://openpaymentsdata.cms.gov/physician/1620445

Daniel E. Spratt

Honoraria: Varian Medical Systems

Consulting or Advisory Role: Janssen Oncology, AstraZeneca, Boston Scientific, Bayer, Blue Earth Diagnostics, Varian Medical Systems

Research Funding: Janssen (Inst)

Open Payments Link: https://openpaymentsdata.cms.gov/physician/869226

Felix Feng

Stock and Other Ownership Interests: Artera

Consulting or Advisory Role: Janssen Biotech, Astellas Pharma, SerImmune, Foundation Medicine, Exact Sciences, Bristol Myers Squibb, Varian Medical Systems, Novartis, Roivant, Bayer, BlueStar Genomics, Myovant Sciences, Tempus, Artera

Research Funding: Zenith Epigenetics

Tomasz M. Beer

Employment: Exact Sciences

Stock and Other Ownership Interests: Arvinas, Salarius Pharmaceuticals, Exact Sciences

Consulting or Advisory Role: Arvinas, Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Constellation Pharmaceuticals, GRAIL, Janssen, Pfizer, Sanofi, AbbVie, Sapience Therapeutics, Amgen, Dantari Pharmaceuticals, GlaxoSmithKline

Research Funding: Alliance Foundation Trials (Inst), Astellas Pharma (Inst), Boehringer Ingelheim (Inst), Corcept Therapeutics (Inst), Endocyte (Inst), Freenome (Inst), GRAIL (Inst), Harpoon Therapeutics (Inst), Janssen Research & Development (Inst), Medivation (Inst), Sotio (Inst), Theraclone Sciences (Inst), Zenith Epigenetics (Inst), Bayer (Inst)

Emmanuel S. Antonarakis

Honoraria: Sanofi, Dendreon, Medivation, Janssen Biotech, ESSA, Astellas Pharma, Merck, AstraZeneca, Clovis Oncology, Amgen, Bayer, Blue Earth Diagnostics, Bristol Myers Squibb/Celgene, Celgene, Constellation Pharmaceuticals, Curium Pharma, Lilly, Exact Sciences, Foundation Medicine, GlaxoSmithKline, InVitae, ISMAR Health Care, Tempus, Orion, AIkido Pharma

Consulting or Advisory Role: Sanofi, Dendreon, Janssen Biotech, ESSA, Merck, AstraZeneca, Clovis Oncology, Lilly, Bayer, Amgen, Astellas Pharma, Blue Earth Diagnostics, Bristol Myers Squibb/Celgene, Constellation Pharmaceuticals, Curium Pharma, Exact Sciences, Foundation Medicine, GlaxoSmithKline, InVitae, ISMAR Health Care, Medivation, Tempus, Orion, AIkido Pharma

Research Funding: Janssen Biotech (Inst), Johnson & Johnson (Inst), Sanofi (Inst), Dendreon (Inst), Aragon Pharmaceuticals (Inst), Exelixis (Inst), Millennium (Inst), Genentech (Inst), Novartis (Inst), Astellas Pharma (Inst), Tokai Pharmaceuticals (Inst), Merck (Inst), AstraZeneca (Inst), Clovis Oncology (Inst), Constellation Pharmaceuticals (Inst), Celgene, Clovis Oncology

Patents, Royalties, Other Intellectual Property: Co-inventor of a biomarker technology that has been licensed to Qiagen

Travel, Accommodations, Expenses: Sanofi, Dendreon, Medivation

No other potential conflicts of interest were reported.

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