Relugolix vs Leuprolide for Prostate Cancer

(REPLACE-CV Trial)

Recruiting at 111 trial locations

Overseen By Clinical Trials at Myovant

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sumitomo Pharma Switzerland GmbH

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial compared the safety and heart-related risks of two hormone-lowering medications, relugolix and leuprolide acetate, in adults with prostate cancer. These drugs help manage cancer by reducing testosterone levels. The study was discontinued, but patients can continue their treatment for a certain period. Relugolix is the first oral medication of its kind and was approved by the FDA based on previous study results.

Eligibility Criteria

Men over 18 with prostate cancer who need androgen deprivation therapy for at least a year can join. They should have a history of cardiovascular disease or multiple risk factors like being over 55, hypertension, high cholesterol, smoking, or family history of heart disease. Excluded are those with recent significant heart issues, uncontrolled blood pressure, long-term hormone treatments for prostate cancer (>18 months), brain metastases, or other active cancers.

Inclusion Criteria

I am eligible for both treatments offered in the study.

Has voluntarily signed and dated the informed consent form prior to baseline visit

I can think clearly enough to answer questions and participate in study activities.

Exclusion Criteria

Metastases to brain per prior clinical evaluation

My doctor plans to change my hormone therapy drugs during the study.

Treatment with any investigational product within specified timeframes

Treatment Details

Interventions

• Leuprolide Acetate (Hormone Therapy)
• Relugolix (Hormone Therapy)

Trial Overview The trial is testing the safety of two prostate cancer treatments: Relugolix and Leuprolide Acetate. It focuses on their effects on major cardiovascular events in patients receiving these drugs as part of their treatment plan.

Participant Groups

Group I: Relugolix Experimental Treatment 1 Intervention

Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1

Group II: Leuprolide Acetate Active Control 1 Intervention

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)

Leuprolide Acetate is already approved in Canada, Japan for the following indications:

Approved in Canada as Lupron for:

• Prostate cancer
• Endometriosis
• Uterine fibroids
• Precocious puberty

Approved in Japan as Leuprolide Acetate for:

• Prostate cancer
• Endometriosis
• Uterine fibroids
• Precocious puberty

Who Is Running the Clinical Trial?

Sumitomo Pharma Switzerland GmbH

Lead Sponsor

Trials

19

Recruited

6,900+

Myovant Sciences GmbH

Lead Sponsor

Trials

23

Recruited

12,500+