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GnRH Agonist

Relugolix vs Leuprolide for Prostate Cancer

Phase 2

Recruiting

Led By Alicia Morgans, MD

Research Sponsored by Dana-Farber Cancer Institute

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 at 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how the standard prostate cancer treatments, Leuprolide & Relugolix, affect quality of life, blood levels, cholesterol, & blood sugar.

Who is the study for?

Men over 18 with prostate cancer who need androgen deprivation therapy (ADT) but haven't had it before. They must be able to sign consent, have a testosterone level >200 ng/mL, good organ function, no prior GnRH treatments, and agree to use contraception. Excludes those with allergic reactions to similar drugs or recent major heart events.

What is being tested?

The trial compares the effects of two ADT medications for prostate cancer—Relugolix and Leuprolide—on quality of life, blood levels, cholesterol, and blood sugar. Participants will receive one of these standard treatments as per their labeling instructions.

What are the potential side effects?

Possible side effects include hot flashes, fatigue, sexual dysfunction, bone density loss which could lead to fractures or osteoporosis; changes in mood or memory; injection site pain for Leuprolide; increased risk for heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

9-month Quality of Life (QOL) Score

Secondary study objectives

12-month Hot flash related daily interference scale (HFRDIS)

12-month Quality of Life (QOL) Score

9-month EPIC-26 Sexual Function Summary Score

+3 more

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

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: Arm A: RelugolixExperimental Treatment1 Intervention

55 participants will be randomized in a 1:1 fashion to Relugolix and stratified by intent to treat with radiation and will complete study procedures as outlined: * Surveys at baseline and at months 3, 6, 9, and 12. * Medication diary entries. * Cycles 1 - 6: --Days 1 - 28 of 28 day cycle: Predetermined dose of Relugolix. Participant will self-administer at home. * Follow up visits every 3 months for 12 months.

Group II: Arm B: LeuprolideActive Control1 Intervention

55 participants will be randomized in a 1:1 fashion to Leuprolide and stratified by intent to treat with radiation and will complete study procedures as outlined: * Surveys at baseline and at months 3, 6, 9, and 12. * Cycle 1 and Cycle 4: --Day 1 of 28 day cycle: Predetermined dose of Leuprolide. Injection will be administered in clinic. * Follow up visits every 3 months for 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Relugolix

2016

Completed Phase 3

~5360

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