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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

Short name HERO

NCTNCT03085095 (opens ClinicalTrials.gov in a new tab)Other idMVT-601-3201Other id2017-000160-15Other id2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,134 participants (actual)
Sponsor
Myovant Sciences GmbH · Industry
Design
Randomized · Open label (no masking)
Countries
22 countries

United States, Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom

Start
18 Apr 2017
Primary completion
25 Oct 2019
Completion
26 Nov 2021
First posted
21 Mar 2017
Last update posted
18 Jan 2022
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 3

    HERO

    NCT03085095

    18 Apr 2017 to 26 Nov 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter \[ng/dL\]) in participants with androgen-sensitive advanced prostate cancer.

Interventions

  • RelugolixDrug
  • Leuprolide AcetateDrug

Arms2

  • Experimental

    Relugolix

    Relugolix for 48 weeks

  • Active comparator

    Leuprolide Acetate

    Leuprolide acetate for 48 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Sustained Castration Rate

    Time frame · From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)

    Registry description

    Sustained castration rate defined as the cumulative probability of testosterone suppression to \< 50 nanogram (ng)/deciliter (dL). The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants. The lower bound of the 95% confidence interval (CI) for the cumulative probability of sustained testosterone suppression in the relugolix treatment group must have been ≥ 90% to meet evaluation criteria for efficacy.

Secondary outcomes(20)

  1. Castration Rate At Week 1 Day 4

    Time frame · Week 1 Day 4 (Day 4)

    Registry description

    Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

  2. Castration Rate At Week 3 Day 1

    Time frame · Week 3 Day 1 (Day 15)

    Registry description

    Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

  3. Confirmed Prostate-specific Antigen (PSA) Response Rate

    Time frame · Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)

    Registry description

    Confirmed PSA response defined as \> 50% reduction in PSA from baseline at Week 3 Day 1 followed with confirmation at Week 5 Day 1.

  4. Profound Castration Rate At Week 3 Day 1 (Day 15)

    Time frame · Week 3 Day 1 (Day 15)

    Registry description

    Castration rate defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

  5. Follicle-stimulating Hormone (FSH) Level

    Time frame · Week 25 Day 1 (Day 169)

    Registry description

    To evaluate the effect of relugolix and leuprolide acetate on FSH suppression.

  6. PSA Response Rate At Week 3 Day 1

    Time frame · Week 3 Day 1 (Day 15)

    Registry description

    PSA response defined as \> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

  7. PSA Response Rate At Week 5 Day 1

    Time frame · Week 5 Day 1 (Day 29)

    Registry description

    PSA response defined as \> 50% reduction in PSA from baseline. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

  8. Testosterone Recovery Rate

    Time frame · Day 90 follow-up

    Registry description

    The cumulative probability of testosterone recovery back to \> 280 ng/dL (lower limit of the normal range), back to ≥ 50 ng/dL (definition of castration), and back to \> 280 ng/dL or baseline at 90 days after drug discontinuation was assessed. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

  9. Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1

    Time frame · Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)

    Registry description

    Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.

  10. Profound Castration Rate At Week 1 Day 4 (Day 4)

    Time frame · At Week 1 Day 4 (Day 4)

    Registry description

    Castration rate defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated for each treatment group using the Kaplan-Meier method and reported as percentage of participants.

  11. Sustained Profound Castration Rate From Week 25 Day 1 Through Week 49 Day 1

    Time frame · Week 25 Day 1 (Day 169) through Week 49 Day 1 (Day 337)

    Registry description

    Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.

  12. Undetectable PSA Rate

    Time frame · Week 25 Day 1 (Day 169)

    Registry description

    Defined as the proportion of participants with PSA concentration \< 0.02 ng/milliliter (mL).The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.

  13. Rate Of PSA Progression-free Survival

    Time frame · Week 49 Day 1 (Day 337)

    Registry description

    PSA progression was defined as the first increase in PSA of 25% or greater and 2 ng/mL or greater above the nadir with confirmation by a second consecutive PSA measurement at least 3 weeks later. For participants without declining PSA from baseline, a PSA increase of ≥ 25% and ≥ 2 ng/mL from baseline beyond 12 weeks was considered PSA progression. The rate of progression-free survival was estimated using the Kaplan-Meier method and reported as percentage of participants.

  14. Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organisation Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30

    Time frame · Baseline, Week 49 Day 1 (Day 337)

    Registry description

    The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. The global health and quality of life domain is presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).

  15. Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30

    Time frame · Baseline, Week 49 Day 1 (Day 337)

    Registry description

    The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).

  16. Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains

    Time frame · Baseline, Week 49 Day 1 (Day 337)

    Registry description

    Subscales for assessment of hormonal treatment-related symptoms (6 items) and sexual activity and function (6 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).

  17. Change From Baseline In QoL Total Score For Urinary And Bowel Symptoms Domains As Assessed By The EORTC-QLQ-PR25

    Time frame · Baseline, Week 49 Day 1 (Day 337)

    Registry description

    Subscale assessments of urinary symptoms (9 items) and bowel symptoms (4 items) from the EORTC-QLQ-PR25 25-item prostate cancer module of the EORTC are presented. Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale. A decrease in symptom scores indicates improvement (lower level of symptoms/problems).

  18. Change From Baseline In QoL Total Score As Assessed By The European Quality Of Life 5-Dimension 5-Level Questionnaire (EuroQoL EQ-5D-5L)

    Time frame · Baseline, Week 49 Day 1 (Day 337)

    Registry description

    The EuroQoL EQ-5D-5L comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1 as numerical score), slight problems (2 as numerical score), moderate problems (3 as numerical score), severe problems (4 as numerical score), and extreme problems (5 as numerical score). The total score ranges from 0 to 100. A decrease in score indicates improvement.

  19. Percent Change From Baseline In Serum Concentrations Of Luteinizing Hormone

    Time frame · Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)

    Registry description

    Blood samples were collected from participants for hormonal measurements.

  20. Percent Change From Baseline In Serum Concentrations Of FSH

    Time frame · Week 1 Day 4 (Day 4), Week 5 Day 1 (Day 29), Week 25 Day 1 (Day 169), and Week 49 Day 1 (Day 337)

    Registry description

    Blood samples were collected from participants for hormonal measurements.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)

Sustained Castration Rate

GroupValue (percentage of participants)
Relugolix96.7
Leuprolide Acetate88.8
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 1 Day 4 (Day 4)

Castration Rate At Week 1 Day 4

GroupValue (percentage of participants)
Relugolix56.04
Leuprolide Acetate0.00
Secondary outcomeNumber· Week 3 Day 1 (Day 15)

Castration Rate At Week 3 Day 1

GroupValue (percentage of participants)
Relugolix98.71
Leuprolide Acetate12.05
Secondary outcomeNumber· Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)

Confirmed Prostate-specific Antigen (PSA) Response Rate

GroupValue (percentage of participants)
Relugolix79.4
Leuprolide Acetate19.8
Secondary outcomeNumber· Week 3 Day 1 (Day 15)

Profound Castration Rate At Week 3 Day 1 (Day 15)

GroupValue (percentage of participants)
Relugolix78.38
Leuprolide Acetate0.98
Secondary outcomeMean· Week 25 Day 1 (Day 169)

Follicle-stimulating Hormone (FSH) Level

GroupValue (IU/L)Spread
Relugolix1.721.376
Leuprolide Acetate5.953.071
Secondary outcomeNumber· Week 3 Day 1 (Day 15)

PSA Response Rate At Week 3 Day 1

GroupValue (percentage of participants)
Relugolix80.1
Leuprolide Acetate20.1
Secondary outcomeNumber· Week 5 Day 1 (Day 29)

PSA Response Rate At Week 5 Day 1

GroupValue (percentage of participants)
Relugolix94.5
Leuprolide Acetate79.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
RelugolixRelugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.7 / 62276 / 622493 / 622
Leuprolide AcetateLeuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, and Taiwan), every 3 months by subcutaneous injection.9 / 30847 / 308239 / 308

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

4 results

Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.

Shore et al. 2020The New England journal of medicinecited by 346

PMID 32469183DOI 10.1056/nejmoa2004325PUB-32469183

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer.

Shore et al. 2023Advances in therapycited by 14

PMID 37713020PMC10567896DOI 10.1007/s12325-023-02634-7PUB-37713020

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2022

Plain language summary of the HERO study comparing relugolix with leuprolide for men with advanced prostate cancer.

Shore et al. 2022Future oncology (London, England)cited by 3

PMID 35587650DOI 10.2217/fon-2022-0172PUB-35587650

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: 1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate. 2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with 1 of the following clinical disease state presentations: 1. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery; or 2. Newly diagnosed androgen-sensitive metastatic disease; or 3. Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent. 3. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles \[nmol\]/liter \[L\]). 4. Has a serum PSA concentration at the Screening visit of \> 2.0 ng/milliliter (mL) (2.0 microgram \[μg\]/L), or, when applicable, post radical prostatectomy of \> 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound \> 2.0 ng/mL (2.0 μg/L) above the post interventional nadir. 5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline. Key Exclusion Criteria: 1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy. 2. Previously received gonadotropin-releasing hormone analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for \> 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot. 3. Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen). 4. Metastases to brain per prior clinical evaluation. 5. Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months. 6. Active conduction system abnormalities. 7. Uncontrolled hypertension.

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