Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Relugolix — DRUG
  Relugolix tablet
• Leuprolide Acetate — DRUG
  Leuprolide acetate injection

Study Details

This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.

Key Dates

Start date

Jan 25, 2023

Status verified

Aug 2025

Primary completion

Jan 2, 2025

Completion

Jan 2, 2025

Study Design

Enrollment

387 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Relugolix
  Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
• Active Comparator: Leuprolide Acetate
  Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)

Primary Outcome Measure

Incidence of Safety Outcomes [ Time Frame: Screening; Day 1; 3, 6, 9, and 12 months; and every 3 months thereafter ]

Locations (108)

Find similar trials in Mobile, AL

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