Study of Relugolix in Men With High-Risk Metastatic Castration-Sensitive Prostate Cancer or Metastatic Castration-Resistant Prostate Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Metastatic Castration-sensitive Prostate Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
This is an open-label, single-cohort study to assess the safety and tolerability of relugolix in combination with abiraterone plus prednisone for 12 weeks in men with high-risk mCSPC or mCRPC being treated with standard-of-care leuprolide acetate with abiraterone plus prednisone and in whom abirater...
This is an open-label, single-cohort study to assess the safety and tolerability of relugolix in combination with abiraterone plus prednisone for 12 weeks in men with high-risk mCSPC or mCRPC being treated with standard-of-care leuprolide acetate with abiraterone plus prednisone and in whom abiraterone has been well tolerated (that is, without evidence of hepatotoxicity requiring dose adjustment for abiraterone) for a minimum of 12 weeks. The study will consist of a 45-day screening period followed by a 12-week treatment period. All participants, either with high-risk mCSPC or mCRPC, are required to have been treated with standard-of-care leuprolide acetate with abiraterone plus prednisone for a minimum of 12 weeks prior to baseline (Day 1). Participants will be transitioned from standard-of-care leuprolide acetate 3-month injection to relugolix; with relugolix treatment initiated the day the next dose of leuprolide acetate (3-month injection) is scheduled for administration with the prior dosing regimen of abiraterone plus prednisone being continued. In addition to safety and tolerability, the study will also provide safety data as participants transition from injectable leuprolide acetate to treatment with relugolix as the androgen-deprivation component of the treatment.
Tracking Information
- NCT #
- NCT04666129
- Collaborators
- Not Provided
- Investigators
- Study Director: Myovant Medical Monitor Myovant Sciences