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HERO Phase 3 Trial: Relugolix vs. Leuprolide Acetate for Advanced Prostate Cancer

Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center, presents the key aspects of the HERO phase 3 trial. The Hero trial looked at Relugolix, an oral GnRH receptor antagonist, versus Leuprolide Acetate for the treatment of advanced prostate cancer. Following this in an interview with Celestia S. Higano, MD, section editor of the ADT Next Generation Learning Center on Grand Rounds in Urology, about the study’s findings, and the implications that this exciting new development in prostate cancer treatment could have in the field of urology.

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HERO Phase 3 Trial: Relugolix vs. Leuprolide Acetate for Advanced Prostate Cancer

Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center, presents the key aspects of the HERO phase 3 trial. The Hero trial looked at Relugolix, an oral GnRH receptor antagonist, versus Leuprolide Acetate for the treatment of advanced prostate cancer. Following this in an interview with Celestia S. Higano, MD, section editor of the ADT Next Generation Learning Center on Grand Rounds in Urology, about the study’s findings, and the implications that this exciting new development in prostate cancer treatment could have in the field of urology.

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Prostate Imaging and Biopsy Controversies

Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center, discusses the evolution of transrectal (TR) versus transperineal (TP) prostate biopsy, and compares the efficacy of multi-parametric MRI (mpMRI) versus next generation micro-ultrasound. He goes on to discuss several studies that review the complication rates of TR and TP biopsy, differences in their diagnostic sensitivity, and various procedural techniques associated with TP prostate biopsy. Dr. Shore then examines several landmark studies that summarize the clinical utility of mpMRI and micro-ultrasound and describes the strengths and weaknesses associated with each technique. He concludes by discussing preliminary data comparing the diagnostic performance of micro-ultrasound to mpMRI.

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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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Preserving Independent Urology: LUGPA’s First Decade

Neal D. Shore, MD and E. David Crawford, MD, discuss Dr. Shore’s recent MedReview article (excerpted and linked below) on the ways in which the Large Urology Group Practice Association, or LUGPA, has advocated on behalf of community urology physicians and patients over the last ten years. Dr. Shore discusses how the organization has fought for legislative change to improve patient access to physicians of their choice, worked to ensure the availability of the latest in imaging and diagnostic technology for community urologists, and, in the face of increased consolidation of the healthcare industry, promoted value-based healthcare above volume-based healthcare, concluding in the article that:

“Eleven years after LUGPA’s inception, its passion and commitment to protecting and preserving the independent practice of urology remain stronger than ever. Without LUGPA, there would be far fewer opportunities for independent urology practices, fair-balanced education, networking, or external benchmarking than we have today. LUGPA groups have been able to integrate essential urologic services at a lower cost than their hospital competitors. Many of our member practices have become urologic centers of excellence with subspecialty lines of service and innovative, cost-effective pathways that optimize patient outcomes.

“Innovation springs from independence, not bureaucracy. Independent practitioners have the freedom and flexibility to share decision-making with their patients and to rapidly implement, test, and adapt new diagnostics, therapeutics, and pathways. Backed by a robust organization such as LUGPA, independent urologists can implement innovative approaches that significantly improve the health of their patients and the sustainability of their practices. Such nimbleness is especially crucial given the current rapid pace of change in urology. Aligning the interests of patients, providers, and payers by promoting value-based care at independent, integrated physician practices is LUGPA’s ongoing mission; our rallying cry should be to continue that mission in an open, transparent, and inclusive fashion.” (Used with permission from MedReviews / Reviews in Urology, which holds the copyright to the original article.)

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