Journal article
A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer
Targeted oncology, v 18(3), pp 383-390
01 May 2023
PMID: 37060432
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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 of relugolix, an oral non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist, in combination with abiraterone acetate (abiraterone) and apalutamide, a phase I study was undertaken.
This is an ongoing, 52-week, open-label, parallel cohort study of relugolix in combination with abiraterone in men with metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC) [Part 1] and apalutamide in men with mCSPC or non-metastatic castration-resistant prostate cancer (nmCRPC) [Part 2]. Eligible patients treated with leuprolide acetate or degarelix with abiraterone or apalutamide prior to baseline, at which time they were transitioned to relugolix. Assessments included reporting of adverse events, clinical laboratory tests, vital sign measurements, electrocardiogram (ECG) parameters, and testosterone serum concentrations. In this interim report, patients completing ≥12 weeks were included.
Overall, 15 men were enrolled in Part 1 and 10 in Part 2. Adverse events were mostly mild-to-moderate in intensity and were consistent with the known safety profiles of the individual medications. No transition (from prior ADT treatment)- or time-related trends in clinical laboratory tests, vital sign measurements, or ECG parameters were observed. Mean testosterone concentrations remained below castration levels.
Combination therapy of relugolix and abiraterone or apalutamide was associated with a favorable safety and tolerability profile consistent with the known profiles of the individual medications. Castration levels of testosterone were maintained after transitioning to relugolix from other ADTs.
ClinicalTrials.gov identifier: NCT04666129.
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Details
- Title
- A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer
- Creators
- Jose De La Cerda - Urology San AntonioCurtis Dunshee - Arizona Pain SpecialistsLawrence Gervasi - Southwest General Health CenterPaul Sieber - Urology AssociatesLaurence Belkoff - Main Line HealthRonald Tutrone - Chesapeake Urology AssociatesSophia Lu - Myovant SciencesSergio C Gatoulis - PfizerBruce Brown - Myovant SciencesElizabeth Migoya - Myovant SciencesNeal Shore - Carolina Urologic Research Center
- Publication Details
- Targeted oncology, v 18(3), pp 383-390
- Publisher
- Springer Nature
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:000969648300003
- Scopus ID
- 2-s2.0-85152580847
- Other Identifier
- 991021916911504721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Oncology