Carolina Urologic Research Center

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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