Neal D. Shore, MD

Neal D. Shore, MD

Carolina Urologic Research Center

Myrtle Beach, South Carolina

Neal D. Shore, MD, FACS, graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Kettering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center and is the Chief Medical Officer, Strategic Growth and Pharmacy, GenesisCare, US.

Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored or coauthored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, Maple Tree Alliance, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy for the Large Urology Group Practice Association (LUGPA) Specialty Network. He also co-chairs the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP and World Journal of Urology, and he also serves as an editor of Everyday Urology-Oncology. He is a Fellow of the American College of Surgeons.

Disclosures:

Dr. Shore has the following disclosures:
- Advisory Committee Member: Amgen, Astellas, Bayer, Dendreon, Ferring, Janssen, Merck, Pfizer, Sanofi, Tolmar
- Consultant: Amgen, Astellas, Bayer, Dendreon, Ferring, Janssen, Merck, Pfizer, Sanofi, Tolmar

Talks by Neal D. Shore, MD

2025 Medicare Part D Changes: Physician’s Perspective

Mark N. Painter, CPMA, MBS, Managing Partner, Consulting LLC, CEO, PRS Urology Service Corporation, Vice President of Coding and Reimbursement Information and CEO Relative Value Studies, Inc. is joined by Neal D. Shore, MD, FACS and David S. Morris, MD, FACS to discuss the physician’s perspective on the upcoming Medicare Part D updates. They share the benefits of these changes and the possible hardships as well.

In this third part of this series, Mark briefly highlights the Medicare Part D changes, such as the reduction of the maximum out-of-pocket expenditure and the Medicare Prescription Payment Plan (MPPP) or “smoothing option”, that the first part of this series covers in more detail. Neal D. Shore, MD, FACS and David S. Morris, MD, FACS then join Mark to share their point of view as physicians on how they are planning to maneuver these changes in the best way. David S. Morris, MD, FACS discusses how he thinks these changes will give a positive outlook to a patient’s finances, for example with the smoothing option or through grants. Also, Neal D. Shore, MD, FACS shares how offices have to prepare to help patients through the process of understanding and taking advantage of these upcoming updates.

This 15-minute discussion concludes with all speakers agreeing that the financial burden on the patient is key when it comes to medications, but they are cautiously optimistic that these upcoming changes will benefit patients, although many will still rely heavily on grants and funding to get the medications they need. Both physicians share in their hope that the upcoming Medicare Part D changes will be a step in the right direction to making healthcare more accessible to all patients and a reminder: Open Enrollment begins October 15, 2024, and runs through December 7, 2024.

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PSMA PET-CT: Clinical Applications

In this presentation, supported by Telix Pharmaceuticals, Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center in Myrtle Beach, South Carolina, presents advances in PSMA PET-CT imaging for staging, prognosis, and clinical management of prostate cancer. He first describes prostate cancer metastases before explaining prostate-specific membrane antigen (PMSA) and how it serves as an effective molecular target for metastatic prostate cancer. Dr. Shore reviews the pros and cons of conventional imaging techniques such as bone scintigraphy, computed tomography (CT), and multiparametric MRI (mpMRI). While treatment guidelines recommend conventional imaging, he notes that bone scans and CT positively identify less than 10% of men with biochemical recurrence and in particular lesions that are <1 cm with a PSA <20 ng/mL. He then compares the benefits of PSMA as an imaging target: it is upregulated in prostate cancer, the degree of expression is positively correlated with tumor state and higher risk of recurrence, there is a positive correlation between PSMA expression and Gleason score/grade, and it may be targeted with either a small molecule or antibody. Dr. Shore reviews numerous studies demonstrating the effectiveness of PSMA PET-CT in metastatic prostate cancer but indicates there is insufficient data on the use of PSMA PET-CT in patients with hormone-naïve disease. He then considers patient selection and points out several downsides including increased cost of care and the potential impact of health disparities. He concludes that PSMA PET-CT is particularly useful in detecting prostate cancer that is otherwise not identified by conventional imaging and in cases with low serum PSA.

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New Prescribing Information on Survival Benefit for Nubeqa® (Darolutamide) Approved

E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology and Professor of Urology at the University of California, San Diego, interviews Neal D. Shore, MD, Medical Director for the Carolina Urologic Research Center in Myrtle Beach, about the recent FDA amendment to the package insert for NUBEQA®, or darolutamide. The amendment includes new information for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) from the ARAMIS trial on overall survival and other endpoint data, including time to pain progression and time to the requirement for cytotoxic chemotherapy. Drs. Crawford and Shore discuss how the recent data demonstrating darolutamide’s overall survival benefit validates the previous use of metastasis-free survival as a surrogate for value. They also talk about the value of darolutamide for patients with nmCRPC who may not see much benefit to taking another medication. Drs. Crawford and Shore conclude by considering darolutamide’s future, mentioning the ARASENS trial looking at darolutamide’s benefits for patients with metastatic hormone-sensitive prostate cancer and discussing potential new research into darolutamide in the mCRPC space.

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The HERO Study and the Approval of Relugolix

E. David Crawford, MD, Professor of Urology at UC San Diego and Editor-in-Chief of Grand Rounds in Urology, interviews Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center, and Daniel J. George, MD, Director of Genitourinary Oncology at Duke Cancer Center, about relugolix, which became the first oral testosterone-suppressive drug approved by the FDA on Friday, December 18, 2020. Drs. Shore and George discuss the results of the international, randomized HERO study, which looked at patients with advanced prostate cancer and found that relugolix, a daily oral GNRH antagonist, had a 97% sustained T-suppression rate as compared to leuprolide’s 88% sustained T-suppression rate. In addition to this high degree of efficacy, they emphasize that patients taken off relugolix saw their testosterone return to higher levels within 90 days than patients taken off leuprolide, which is important for patient quality-of-life. Drs. Shore and George also underline that patients in the relugolix arm of the HERO study saw a more than 50% reduction in risk of major adverse cardiovascular events compared with patients in the leuprolide arm, which suggests that relugolix might be a safer option for prostate cancer patients at high cardiovascular risk. Other topics covered include the benefits of antagonists versus agonists and the possible risks of patient non-compliance.

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GRU Challenging Case: Androgen Deprivation Therapy

Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center, discusses the physiological and economic factors impacting the ADT selection process. He particularly emphasizes the impact of the current volume-based and economically incentivized model of treatment and how this can restrict urologists. He also discusses the physiological impacts of drug-drug interactions, alternate modes of administration, and the complex prospect of an oral alternative.

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