Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer

  • Karim Fizazi, M.D.,
  • Neal Shore, M.D.,
  • Teuvo L. Tammela, M.D., Ph.D.,
  • Albertas Ulys, M.D.,
  • Egils Vjaters, M.D.,
  • Sergey Polyakov, M.D.,
  • Mindaugas Jievaltas, M.D.,
  • Murilo Luz, M.D.,
  • Boris Alekseev, M.D.,
  • Iris Kuss, M.D.,
  • Christian Kappeler, Ph.D.,
  • Amir Snapir, M.D., Ph.D.,
  • Toni Sarapohja, M.Sc.,
  • and Matthew R. Smith, M.D., Ph.D.
  • for the ARAMIS Investigators*

    Background- Darolutamide is a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer. We evaluated the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer.

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Managing Nonmetastatic Castration-resistant Prostate Cancer

Joaquin Mateo, Karim Fizazi, Silke Gillessen, Axel Heidenreich, Raquel Perez-Lopez, Wim J.G. Oyen, Neal Shore, Matthew Smith, Christopher Sweeney, Bertrand Tombal, Scott A. Tomlins, Johann S. de Bono. Correspondence information about the author Johann S. de Bono
Associate Editor: Giacomo Novara

Context

Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) have rising prostate-specific antigen (PSA) and castrate testosterone levels, with no radiological findings of metastatic disease on computed tomography and bone scan. Given recent drug approvals for nmCRPC, with many other therapeutics and imaging modalities being developed, management of nmCRPC is a rapidly evolving field that merits detailed investigation.

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A New Sustained-Release, 3-Month Leuprolide Acetate Formulation Achieves and Maintains Castrate Concentrations of Testosterone in Patients With Prostate Cancer

Neal D.Shore, MD, SílviaGuerrero, PhD, Rosa MaSanahuja, MS, GemmaGambús, MD, PhD, AntonioParente, Ph

Purpose

This clinical trial investigated the effectiveness, pharmacokinetic properties, and safety profile of leuprolide acetate 22.5-mg depot, a new 3-month leuprolide depot formulation, as androgen deprivation therapy for patients with prostate cancer.

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A New Sustained-Release, 3-Month Leuprolide Acetate Formulation Achieves and Maintains Castrate Concentrations of Testosterone in Patients With Prostate Cancer

Neal D. Shore, MD1; Sílvia Guerrero, PhD2; Rosa Ma Sanahuja, MS2;Gemma Gambús, MD, PhD2; and Antonio Parente, PhD2

Purpose: This clinical trial investigated the effectiveness, pharmacokinetic properties, and safety profile of leuprolide acetate 22.5-mg depot, a new 3-month leuprolide depot formulation, as androgen deprivation therapy for patients with prostate cancer.

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Phase 1 study of PSMA ADC, an antibody‐drug conjugate targeting prostate‐specific membrane antigen, in chemotherapy‐refractory prostate cancer

Background

Prostate‐specific membrane antigen (PSMA) is a well‐characterized target that is overexpressed selectively on prostate cancer cells. PSMA antibody‐drug conjugate (ADC) is a fully human IgG1 monoclonal antibody conjugated to the microtubule disrupting agent monomethyl auristatin E (MMAE), which is designed to specifically bind PSMA‐positive cells, internalize, and then release its cytotoxic payload into the cells. PSMA ADC has demonstrated potent and selective antitumor activity in preclinical models of advanced prostate cancer. A Phase 1 study was conducted to assess the safety, pharmacokinetics, and preliminary antitumor effects of PSMA ADC in subjects with treatment‐refractory prostate cancer.

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Bone Health in Prostate Cancer, A Conversation with Neal Shore and Oliver Sartor

Neal Shore and Oliver Sartor have a conversation on bone-targeted agent therapies in prostate cancer, specifically focusing on the ALSYMPCA phase three trial; the design, findings, the addition of radium 223 and what this trial has led to today. They review a few other current ongoing trials including the PEACE III single arm trial and other current approaches in understanding combination therapies in bone health.

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Managing the Adverse Effects of Drug Treatments for Advanced Prostate Cancer

Ask The Experts:

Neal D. Shore, MD
Practice Community: Myrtle Beach, South Carolina
Hospital and Institutional Affiliations: Director, CPI, Carolina Urologic Research Center, Myrtle Beach, South Carolina, and President of the Large Urology Group Practice Association
Number of Patients Seen in a Week: 150
Practice Niche: Urologic Oncology

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LUGPA president details decade of successes with eye on future

 

Androgen Receptor Targeted Treatments of Prostate Cancer: 35 Years of Progress with Antiandrogens

E. David Crawford, Paul F. Schellhammer, David G. McLeod, Judd W. Moul‡, Celestia S. Higano, Neal Shore, Louis Denis, Peter Iversen, Mario A. Eisenberger, Fernand Labrie

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Phase I Study of Seviteronel, a Selective CYP17 Lyase and Androgen Receptor Inhibitor, in Men with Castration-Resistant Prostate Cancer

Shilpa Gupta, Luke T. Nordquist, Mark T. Fleming, William R. Berry, Jingsong Zhang, Sharon L. Ervin, Joel R. Eisner, Edwina S. Baskin-Bey and Neal D. Shore

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