What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as GnRH receptor antagonists like Relugolix, often have side effects including hot flashes, fatigue, decreased libido, and erectile dysfunction. Other hormone therapies, such as LHRH agonists (e.g., leuprolide), can cause similar side effects along with potential cardiovascular risks. Anti-androgens may lead to gynecomastia, liver toxicity, and gastrointestinal issues. Chemotherapy agents like docetaxel and cabazitaxel are associated with myelosuppression, neuropathy, and alopecia. Each treatment's side effect profile should be carefully considered in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including GnRH receptor antagonists like Relugolix. Other similar drugs include leuprolide acetate, a GnRH agonist, which has been widely used in prostate cancer therapy. Additionally, androgen receptor signaling inhibitors such as enzalutamide and abiraterone have been approved for advanced stages of the disease. These treatments aim to reduce testosterone levels or block its effects, thereby slowing the progression of prostate cancer.

What other types of research exist?

Promising alternatives to Relugolix for prostate cancer treatment in 2024 include Abarelix Depot, another GnRH antagonist shown to be effective in clinical studies, and Enzalutamide, an androgen receptor inhibitor that has demonstrated superior outcomes in combination with androgen deprivation therapy (ADT) compared to older treatments. Additionally, Degarelix, another GnRH antagonist, has shown efficacy in maintaining testosterone suppression in clinical trials.

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Hormone Therapy

Relugolix vs Leuprolide for Prostate Cancer (REPLACE-CV Trial)

Phase 3

Waitlist Available

Research Sponsored by Sumitomo Pharma Switzerland GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment until date of first confirmed mace, assessed up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include hot flashes, fatigue, diarrhea, constipation and joint pain. Both medications may also affect liver enzymes and testosterone levels which could lead to changes in mood or sexual function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment until date of first confirmed mace, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment until date of first confirmed mace, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until date of first confirmed mace, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Safety Outcomes

Secondary study objectives

Time Course of Events Related to MACE

Side effects data

From 2020 Phase 3 trial • 388 Patients • NCT03049735

11%

Hot flush

11%

Headache

Hypertension

Arthralgia

Upper respiratory tract infection

Avulsion fracture

Ankle fracture

Uterine myoma expulsion

Haematemesis

uterine leiomyoma

Menorrhagia

Pelvic pain

Rhabdomyolysis

Cough

Vitreous detachment

Hypothyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Relugolix Plus E2/NETA (Group A)

Relugolix Plus Delayed E2/NETA (Group B)

Placebo (Group C)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RelugolixExperimental Treatment1 Intervention

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

Group II: Leuprolide AcetateActive Control1 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Relugolix

2016

Completed Phase 3

~5410

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often target the androgen pathway, crucial for cancer cell growth. GnRH receptor antagonists like Relugolix directly inhibit GnRH receptors, reducing testosterone production without causing an initial surge in hormone levels, which can exacerbate symptoms. GnRH agonists, such as leuprolide, initially increase testosterone before downregulating receptors to lower hormone levels. Antiandrogens, like bicalutamide, block androgen receptors, preventing testosterone from stimulating cancer cells. Androgen receptor inhibitors, such as enzalutamide, further block androgen signaling within cancer cells. These treatments are vital as they effectively reduce androgen levels or block their action, slowing cancer progression and alleviating symptoms.