Dr. Patel on initial findings with relugolix vs leuprolide in prostate cancer

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"In this study, we found no difference in patient-reported bowel toxicity in men receiving radiation plus relugolix vs radiation plus leuprolide," says Sagar A. Patel, MD.

In this video, Sagar A. Patel, MD, highlights the background and initial findings from the REVELUTION trial (NCT05320406), comparing relugolix vs leuprolide in combination with radiotherapy for localized prostate cancer. Patel is an assistant professor in the department of radiation oncology and a member of the cancer and control research program at Emory Winship Cancer Institute in Atlanta, Georgia.

Video Transcript:

Could you describe the background for this study?

The premise of this study was that we've been identifying more cardiovascular toxicity, morbidity, and even mortality amongst prostate cancer patients who receive androgen deprivation therapy. This has been highlighted over the past decade and is particularly a problem we see in our catchment area in Atlanta, Georgia amongst comorbid patients in the southeast. In 2020, a new androgen deprivation therapy agent called relugolix was developed and FDA approved. In that seminal trial that compared relugolix vs conventional ADT, also commonly known as leuprolide, they found less cardiovascular morbidity with this new drug. But the mechanism of which this risk reduction may be diminished is unknown. What we developed was the REVOLUTION trial, also known as the relugolix vs leuprolide trial, which is a clinical trial that enrolls men with localized prostate cancer pursuing definitive radiation therapy with concomitant ADT. Those patients are randomized 1:1 between concomitant leuprolide or concomitant relugolix. All patients will receive at least 6 months of ADT. In addition, there is a third arm, which is a parallel control arm of men who are receiving radiation alone without concomitant ADT for their localized prostate cancer. All patients are receiving a baseline cardiovascular CT and a second cardiovascular CT 12 months into treatment. The primary end point is coronary atherosclerosis development between those 3 arms.

What were the key findings from this study?

We presented our initial findings of patient-reported quality-of-life and treatment preferences. Our primary end point of cardiovascular toxicity, especially coronary atherosclerosis, is still ongoing. We expect those results to be accrued and matured in late 2024, so later this year. As of now, we finished accruel of our ADT arms, those men who are getting relugolixand those men who are getting leuprolide. We enrolled 65 total men; 34 were randomized to leuprolide [and] 31 were randomized to relugolix. All patients completed patient-reported quality-of-life questionnaires at baseline and then 3 months and 6 months into treatment. Those questionnaires included AUA IPSS for urinary toxicity assessment, EPIC-CP for urinary incontinence, bowel sexual toxicity assessment, and then the shim questionnaire, the sexual health inventory metric, to measure erectile dysfunction.

What we found, unsurprisingly was that there was no major differences between leuprolide and relugolix for patient-reported quality-of-life metrics. Interestingly, though, we did find that those patients who did receive relugolix had a lower insult to their urinary toxicity as measured by the AUA IPSS questionnaire. That was statistically significant after doing a linear mixed effects model between those 2 arms. With respect to incontinence, bowel toxicity, and sexual toxicity, there was no difference between those 2 arms. One interesting point we found was that the bowel toxicity was not different, which is very important, because in the seminal HERO trial, which was published in 2020 and randomized men to leuprolide vs relugolix, there was an increase in GI toxicity with relugolix, which is not surprising as it's an oral pill, so we anticipate perhaps more GI toxicity with that drug. How that may be impacted with concomitant radiation, specifically radiation delivered to the pelvis impacting the rectum was unknown. In this study, we found no difference in patient-reported bowel toxicity in men receiving radiation plus relugolix vs radiation plus leuprolide.

This transcription has been edited for clarity.

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