Recruitment

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