AUA 2023: Characteristics and Outcomes of Patients with Advanced Prostate Cancer Treated with Relugolix: A Single Center Experience

( The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to an advanced prostate cancer session. Parth Shah presented the results of a single center analysis evaluating the characteristics and outcomes of patients with advanced prostate cancer treated with relugolix.

Relugolix is an oral gonadotropin-releasing hormone (GnRH) antagonist that was FDA approved in December 2020 based on the results of the phase 3 HERO trial that demonstrated:1

  • Superior castration rates through 48 weeks with relugolix versus leuprolide (97% versus 89%)
  • Improved castration potency (Castrate levels at day 4: 56% versus 0%)
  • Enhanced testosterone recovery (Mean testosterone levels 90 days after treatment discontinuation: 288.4 ng/dL versus 58.6 ng/dL)
  • Lower incidence of major adverse CV events (3% versus 6%).

The objective of this study was to evaluate the characteristics and cardiovascular outcomes of prostate cancer patients treated with relugolix at a single institution (Northwestern Memorial Hospital).

The investigators queried The Northwestern Electronic Data Warehouse for prostate cancer patients treated with Relugolix at their institution between December 2020 and July 2022. They extracted data for baseline clinicopathologic characteristics, cardiac health information, Charlson comorbidity index (CCI), and cardiac outcomes following initiation of relugolix.

This study included 230 men, with a mean age of 70.5 years. Relugolix was most commonly prescribed by a radiation oncologist (38%), followed by a medical oncologist (34%), and a urologist (27%). The baseline CCI score among patients treated with relugolix was high (mean: 7.5), and 69% had a history of cardiovascular disease or at least one cardiovascular disease risk factor prior to initiation of therapy. The most common risk factors were a diagnosis of dyslipidemia (49%) and hypertension (47%).

Following initiation of relugolix, 11 major adverse cardiovascular events occurred, with an acute MI (n=3) being the most common, followed by cerebral infarction (n=2) and TIA (n=2). A total of four patients (2%) died during follow-up, of which two were due to cardiac causes.

The authors concluded that the majority of patients prescribed relugolix had a at least one cardiac comorbidity at the time of prescription, with the subsequent rate of major adverse cardiovascular events similar to that observed in the HERO trial. Results of this analysis represent a real-world account of relugolix use in practice and further clarifies the comorbidity profile of users in practice and as well as their adverse event profile with this drug.

Presented by: Parth Shah, Medical Student, Northwestern University Feinberg School of Medicine, Chicago, IL

Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023

  1. Shore ND, et al. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med , 2020.