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  1. Article

    Open Access

    Impact of a rash management guide in patients receiving apalutamide for high-risk localized prostate cancer in the Apa-RP study

    Based on the SPARTAN and TITAN studies, apalutamide is approved for patients with nonmetastatic castration-resistant and metastatic castration-sensitive prostate cancer. Skin rash was a common adverse reaction...

    Neal Shore, Jason Hafron, Daniel Saltzstein in Prostate Cancer and Prostatic Diseases (2024)

  2. Article

    Open Access

    Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer

    In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.

    Robert Hugh Jones, Karim Fizazi in Prostate Cancer and Prostatic Diseases (2023)

  3. Article

    Open Access

    A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer

    Androgen deprivation therapy (ADT), a cornerstone of prostate cancer treatment, is commonly co-prescribed as combination therapy.

    Jose De La Cerda, Curtis Dunshee, Lawrence Gervasi, Paul Sieber in Targeted Oncology (2023)

  4. Article

    Open Access

    The Hospitalization-Related Costs of Adverse Events for Novel Androgen Receptor Inhibitors in Non-Metastatic Castration-Resistant Prostate Cancer: An Indirect Comparison

    Three novel androgen receptor inhibitors are approved in the USA for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC): apalutamide, enzalutamide, and darolutamide. All three therap...

    Neal Shore, Shan Jiang, Viviana Garcia-Horton, Emi Terasawa in Advances in Therapy (2022)

  5. Article

    Open Access

    Real-world patient characteristics associated with survival of 2 years or more after radium-223 treatment for metastatic castration-resistant prostate cancer (EPIX study)

    The real-world EPIX study was conducted to gather information about the characteristics of patients with metastatic castration-resistant prostate cancer (mCRPC) who survived ≥2 years after treatment with the a...

    Daniel J. George, Neeraj Agarwal, Oliver Sartor in Prostate Cancer and Prostatic Diseases (2022)

  6. Article

    Open Access

    Correction: Treating the patient and not just the cancer: therapeutic burden in prostate cancer

    A Correction to this paper has been published: https://doi.org/10.1038/s41391-021-00358-9

    Daniel E. Spratt, Neal Shore, Oliver Sartor in Prostate Cancer and Prostatic Diseases (2021)

  7. Article

    Open Access

    Treating the patient and not just the cancer: therapeutic burden in prostate cancer

    Prostate cancer (PC) is a leading cause of death in older men. Androgen deprivation therapy (ADT) is considered the standard-of-care for men with locally advanced disease. However, continuous androgen ablation...

    Daniel E. Spratt, Neal Shore, Oliver Sartor in Prostate Cancer and Prostatic Diseases (2021)

  8. Article

    Open Access

    Treatment of nonmetastatic castration-resistant prostate cancer: focus on second-generation androgen receptor inhibitors

    Nonmetastatic castration-resistant prostate cancer (nmCRPC) is defined as a rising prostate-specific antigen concentration, despite castrate levels of testosterone with ongoing androgen-deprivation therapy or ...

    Fred Saad, Martin Bögemann, Kazuhiro Suzuki in Prostate Cancer and Prostatic Diseases (2021)

  9. Article

    Open Access

    Efficacy and safety of darolutamide in Japanese patients with nonmetastatic castration-resistant prostate cancer: a sub-group analysis of the phase III ARAMIS trial

    Darolutamide, an oral androgen receptor inhibitor, has been approved for treating nonmetastatic castration-resistant prostate cancer (nmCRPC), based on significant improvements in metastasis-free survival (MFS...

    Hiroji Uemura, Hisashi Matsushima in International Journal of Clinical Oncology (2021)

  10. Article

    Open Access

    Prospective evaluation of fexapotide triflutate injection treatment of Grade Group 1 prostate cancer: 4-year results

    This study was undertaken to determine the safety and efficacy of fexapotide triflutate (FT) 2.5 mg and 15 mg for the treatment of Grade Group 1 prostate cancer.

    Neal Shore, Steven A. Kaplan, Ronald Tutrone, Richard Levin in World Journal of Urology (2020)

  11. Article

    Open Access

    Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer

    In this study, we evaluated real-world data on radium-223 plus abiraterone/prednisone or enzalutamide. Previously, the ERA 223 trial (NCT02043678) demonstrated increased fracture risk with concurrent treatment...

    Neal Shore, Celestia S. Higano, Daniel J. George in Prostate Cancer and Prostatic Diseases (2020)

  12. Article

    Open Access

    A Retrospective Claims Analysis of Advanced Prostate Cancer Costs and Resource Use

    Castration-resistant prostate cancer (CRPC) is associated with high costs and healthcare resource utilization (HCRU).

    Sreevalsa Appukkuttan, Krishna Tangirala, Svetlana Babajanyan in PharmacoEconomics - Open (2020)

  13. Article

    Open Access

    A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients

    To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subj...

    Neal Shore, Ivan Mincik, Mark DeGuenther, Vladimir Student Jr. in World Journal of Urology (2020)

  14. Article

    Open Access

    Prolonged PSA stabilization and overall survival following sipuleucel-T monotherapy in metastatic castration-resistant prostate cancer patients

    Sipuleucel-T is an autologous cellular immunotherapy that is FDA approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC). The IMPACT registry t...

    Eda K. Holl, Megan A. McNamara, Patrick Healy in Prostate Cancer and Prostatic Diseases (2019)

  15. Article

    Open Access

    Evaluation of Clinically Relevant Drug–Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial

    Darolutamide, an androgen receptor antagonist with a distinct molecular structure, significantly prolonged metastasis-free survival versus placebo in the phase III ARAMIS study in men with nonmetastatic castra...

    Neal Shore, Christian Zurth, Robert Fricke, Hille Gieschen in Targeted Oncology (2019)

  16. Article

    Open Access

    Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement

    These studies were undertaken to determine if fexapotide triflutate 2.5 mg transrectal injectable (FT) has significant long-term (LT) safety and efficacy for the treatment of benign prostatic hyperplasia (BPH).

    Neal Shore, Ronald Tutrone, Mitchell Efros, Mohamed Bidair in World Journal of Urology (2018)

  17. Article

    Open Access

    Current approaches to incorporation of radium-223 in clinical practice

    Treatment options for metastatic castration-resistant prostate cancer (mCRPC) have expanded in recent years and include cytotoxic agents (e.g., docetaxel and cabazitaxel), immunotherapy (e.g., sipuleucel-T), o...

    Chris Parker, Axel Heidenreich, Sten Nilsson in Prostate Cancer and Prostatic Diseases (2018)

  18. Article

    Open Access

    Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer

    Zoledronic acid (ZA) or denosumab treatment reduces skeletal-related events; however, the safety of prolonged therapy has not been adequately studied. Here, we describe safety results of extended denosumab the...

    Alison T. Stopeck, Karim Fizazi, Jean-Jacques Body in Supportive Care in Cancer (2016)

  19. Article

    Erratum to: Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer

    Alison T. Stopeck, Karim Fizazi, Jean-Jacques Body in Supportive Care in Cancer (2016)

  20. Article

    Open Access

    Phase I study of patients with non-muscle invasive bladder cancer (NMIBC) treated with vesigenurtacel-L (HS-410) after Bacillus Calmette-Guérin (BCG)

    Gary Steinberg, Neal Shore, Lawrence Karsh in Journal for ImmunoTherapy of Cancer (2015)

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