Relugolix vs Leuprolide for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byAlicia Morgans, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Dana-Farber Cancer Institute
Must be taking: ADT
Must not be taking: Second generation AR therapies
Disqualifiers: Cardiac event, Brain metastases, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label.
The names of the study drugs involved in this study are:
* Leuprolide (type of ADT)
* Relugolix (type of ADT)
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have prior or planned treatment with certain prostate cancer drugs or be on other investigational agents. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Relugolix for prostate cancer?
Research shows that Relugolix is effective in lowering testosterone levels in men with advanced prostate cancer, maintaining these low levels for 48 weeks, and reducing the risk of major heart-related events compared to Leuprolide.
12345Is Relugolix safe for treating prostate cancer compared to Leuprolide?
Relugolix is generally well tolerated and may have a lower risk of major heart-related issues compared to Leuprolide. Both drugs can cause side effects related to testosterone suppression, and Relugolix may also affect heart rhythm and cause harm to unborn babies.
12367How does the drug Relugolix differ from Leuprolide in treating prostate cancer?
Relugolix is unique because it is an oral medication that rapidly lowers testosterone levels without causing an initial surge, unlike Leuprolide, which is given as an injection and can cause a temporary increase in testosterone. Additionally, Relugolix has been shown to reduce the risk of major heart-related side effects compared to Leuprolide.
12345Eligibility Criteria
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.Inclusion Criteria
I have another cancer, but it doesn't affect my current treatment's safety or effectiveness.
Life expectancy of greater than 12 months.
Patients must have testosterone level > 200 ng/mL prior to initiation of ADT.
+12 more
Exclusion Criteria
I am allergic to medications similar to leuprolide or relugolix.
My cancer has spread to my brain.
I do not have any uncontrolled illnesses.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Leuprolide or Relugolix for prostate cancer treatment
12 months
Surveys at baseline and at months 3, 6, 9, and 12; Follow-up visits every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Participant Groups
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.
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.
Leuprolide is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Lupron for:
- Advanced prostate cancer
- Endometriosis
- Uterine leiomyomata
- Central precocious puberty
🇪🇺 Approved in European Union as Eligard for:
- Advanced prostate cancer
- Endometriosis
- Uterine leiomyomata
- Central precocious puberty
🇨🇦 Approved in Canada as Viadur for:
- Advanced prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
Dana-Farber Cancer InstituteBoston, MA
Dana-Farber Cancer Institute at FoxboroughFoxboro, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
Prostate Cancer FoundationCollaborator
PfizerIndustry Sponsor
Myovant Sciences GmbHIndustry Sponsor
References
Phase 3 HERO Trial Finds Relugolix to Be Superior to Leuprolide in Prostate Cancer. [2021]Results from the phase 3 HERO trial(NCT03085095), presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program, indicated that relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone suppression through 48 weeks, fast testosterone recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer.
Relugolix: A Review in Advanced Prostate Cancer. [2023]Relugolix (Orgovyx®), an orally active nonpeptide gonadotropin-releasing hormone (GnRH) receptor antagonist that provides rapid testosterone suppression, is indicated in the USA for the treatment of advanced prostate cancer and in the EU for advanced hormone-sensitive prostate cancer. In the pivotal phase III HERO trial in men with advanced prostate cancer, once-daily oral relugolix (with a loading dose on day 1) led to a sustained castration rate over 48 weeks of treatment of > 90%, a rate that was non-inferior to that provided by intramuscular leuprolide depot every 3 months (with an exploratory analysis further indicating the superiority of relugolix over leuprolide). Relugolix was generally well tolerated, having an adverse event profile that is consistent with testosterone suppression. Furthermore, there is evidence that relugolix may be associated with a lower risk of major adverse cardiac events compared with leuprolide. With the ability to provide the rapid testosterone suppression (with no initial surge in testosterone upon treatment initiation) combined with the benefits of oral administration and potentially improved cardiac safety, relugolix presents a valuable treatment option for men with advanced prostate cancer where androgen deprivation therapy is indicated.
Relugolix vs. Leuprolide Effects on Castration Resistance-Free Survival from the Phase 3 HERO Study in Men with Advanced Prostate Cancer. [2023]Background: Relugolix is an oral GnRH receptor antagonist approved for men with advanced prostate cancer. Relugolix treatment has demonstrated an ability to lower testosterone to sustained castration levels in the phase 4 HERO study. Herein, we describe the results of a secondary endpoint of castration resistance-free survival (CRFS) during 48 weeks of treatment and profile patients with castration-resistant prostate cancer (CRPC). Methods: Subjects were 2:1 randomized to either relugolix 120 mg orally once daily (after a single 360 mg loading dose) or 3-monthly injections of leuprolide for 48 weeks. CRFS, defined as the time from the date of first dose to the date of confirmed prostate-specific antigen progression while castrated or death due to any reason was conducted in the metastatic disease population and the overall modified intention-to-treat (mITT) populations. Results: The CRFS analysis (mITT population) included 1074 men (relugolix: n = 717; leuprolide: n = 357) with advanced prostate cancer as well as 434 men (relugolix: n = 290; leuprolide: n = 144) with metastatic prostate cancer. In the metastatic disease populations, CRFS rates were 74.3% (95% CI: 68.6%, 79.2%) and 75.3% (95% CI: 66.7%, 81.9%) in the relugolix and leuprolide groups, respectively (hazard ratio: 1.03 [0.68, 1.57]; p = 0.84) at week 48. Results in the overall mITT population were similar to the metastatic population. No new safety findings were identified. Conclusions: In men with metastatic disease or in the overall population of the HERO study, CRFS assessed during the 48-week treatment with relugolix was not significantly different than standard-of-care leuprolide. Relugolix had similar efficacy for men with/without CRFS progression events.
Plain language summary of the HERO study comparing relugolix with leuprolide for men with advanced prostate cancer. [2022]This is a summary of a research study (known as a clinical trial) called HERO. The HERO study compared how well relugolix and leuprolide worked in lowering blood testosterone to sustained castration levels in men with advanced prostate cancer. Sustained castration is a blood testosterone level below 50 ng/dl from Day 29 through 48 weeks of treatment.
Cost-effectiveness analysis of androgen deprivation therapy with relugolix for the treatment of advanced prostate cancer. [2023]Relugolix treatment of advanced prostate cancer (APC), like other gonadotropin-releasing hormone-antagonists, results in rapid decrease in testosterone concentrations without the risk of flare, as seen in leuprolide. Despite this benefit over leuprolide, no economic evaluation assessment to ascertain the cost-effectiveness of relugolix has been conducted. Therefore, this study aims to assess the cost-effectiveness of androgen deprivation therapy (ADT) with 120 mg relugolix against 7.5 mg leuprolide for the treatment of APC.
Efficacy and safety of leuprolide acetate 6-month depot for suppression of testosterone in patients with prostate cancer. [2022]This open-label study evaluated the efficacy and safety of a new leuprolide acetate 45 mg 6-month depot formulation in 151 men with prostate cancer who received 2 intramuscular injections administered 24 weeks apart.
First Oral Hormone for Treating Prostate Cancer. [2023]Relugolix (Orgovyx) has been approved for the treatment of advanced prostate cancer. It is the first oral gonadotropin-releasing hormone receptor antagonist.As with other androgen deprivation therapy, there is a risk of prolonging the QT or QTc interval with relugolix. The drug may also cause embryo-fetal toxicity.