Relugolix in combination with abiraterone acetate, apalutamide, or docetaxel in men with advanced prostate cancer (aPC): A phase 1, three-part, open-label, parallel-cohort study.

• DOI: 10.1200/jco.2022.40.6_suppl.tps207
• Publication Date: 2022-02-16T21:35:25Z
• Authors: Jose De La Cerda; Elizabeth Migoya; Bruce Brown; Sophia Lu; Fabian Zohren; Ronald F. Tutrone; Curtis Dunshee
• Keywords: Tolerability; Abiraterone acetate

TPS207 Background: Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) analogs or receptor antagonists is a cornerstone of prostate cancer treatment. As disease progresses, agents complementary mechansims are co-prescribed ADT to suppress extra-testicular testosterone production block androgen receptors on cells. Relugolix (120 mg) an oral non-peptide GnRH antagonist approved in the US for treatment aPC. In phase 3 study, relugolix maintained suppression castration levels 96.7% men up 48 weeks (wks), superiority leuprolide acetate. was well tolerated and associated 54% lower risk major adverse cardiovascular events relative acetate (Shore N, NEJM 2020;382;23). To formally assess safety tolerability combination relugolix, 1 study aPC has been undertaken. Methods: This three-part, open-label, parallel-cohort abiraterone metastatic castration-sensitive (mCSPC) castration-resistant (mCRPC) (Part 1), apalutamide mCSPC non-metastatic catration-resistant (nmCRPC) 2), docetaxel mCRPC 3). Each part consists 45-day screening period, 12-wk primary period 40-wk extension period. All required have treated (eg, degarelix) minimum 12 wks, 6 one cycle prior baseline (Day 1) visit. Men will be transitioned from degarelix mg [Part 3] 240 2] once daily after single loading dose 360 mg); approximate date next analog injection scheduled; each continue as previously prescribed. Hence, provide three different year addition, data transition injectable relugolix. Enrollment into began March 2021. A protocol amendment July 2021 include Part 2 add Screening initiated August it expected initiate January 2022. Clinical trial information: NCT04666129.