A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer

• DOI: 10.1007/s11523-023-00967-5
• Publication Date: 2023-04-15T10:02:01Z
• Authors: Jose De La Cerda; Curtis Dunshee; Lawrence Gervasi; Paul Sieber; Laurence Belkoff; Ronald Tutrone; Sophia Lu; Sergio C. Gatoulis; Bruce Brown; Elizabeth Migoya; Neal Shore
• Keywords: Tolerability; Abiraterone acetate

Androgen deprivation therapy (ADT), a cornerstone of prostate cancer treatment, is commonly co-prescribed as combination therapy. To better understand the safety and tolerability profile relugolix, an oral non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, in with abiraterone acetate (abiraterone) apalutamide, phase I study was undertaken. This ongoing, 52-week, open-label, parallel cohort relugolix men metastatic castration-sensitive (mCSPC) or castration-resistant (mCRPC) [Part 1] apalutamide mCSPC non-metastatic (nmCRPC) 2]. Eligible patients treated leuprolide degarelix prior to baseline, at which time they were transitioned relugolix. Assessments included reporting adverse events, clinical laboratory tests, vital sign measurements, electrocardiogram (ECG) parameters, testosterone serum concentrations. In this interim report, completing ≥12 weeks included. Overall, 15 enrolled Part 1 10 2. Adverse events mostly mild-to-moderate intensity consistent known profiles individual medications. No transition (from ADT treatment)- time-related trends ECG parameters observed. Mean concentrations remained below castration levels. Combination associated favorable Castration levels maintained after transitioning from other ADTs. ClinicalTrials.gov identifier: NCT04666129