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

NCT03085095 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MVT-601-32012017-000160-15
• Study Type: interventional
• Target: 1,134
• Locations: 21 countries
• Sites: 157

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Sustained Castration Rate

  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.

  From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)

Secondary Outcomes (25)

• Castration Rate At Week 1 Day 4

  Week 1 Day 4 (Day 4)

• Castration Rate At Week 3 Day 1

  Week 3 Day 1 (Day 15)

• Confirmed Prostate-specific Antigen (PSA) Response Rate

  Week 3 Day 1 (Day 15) and Week 5 Day 1 (Day 29)

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

  Week 3 Day 1 (Day 15)

• Follicle-stimulating Hormone (FSH) Level

  Week 25 Day 1 (Day 169)

Other Outcomes (1)

• Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)

  From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)

Study Arms (2)

Relugolix

EXPERIMENTAL

Relugolix for 48 weeks

Drug: Relugolix

Leuprolide Acetate

ACTIVE COMPARATOR

Leuprolide acetate for 48 weeks

Drug: Leuprolide Acetate

Interventions

Relugolix DRUG

Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1

Also known as: TAK-385, MVT-601, RVT-601, T-1331285

Relugolix

Leuprolide Acetate DRUG

Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection

Also known as: Leuprolide

Leuprolide Acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
• 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:
• 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
• Newly diagnosed androgen-sensitive metastatic disease; or
• Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent.
• Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles \[nmol\]/liter \[L\]).
• 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.
• Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.

You may not qualify if:

• 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.
• 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.
• Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen).
• Metastases to brain per prior clinical evaluation.
• Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months.
• Active conduction system abnormalities.
• Uncontrolled hypertension.

Sponsors & Collaborators

• Myovant Sciences GmbH: lead

Study Sites (162)

Tucson

Tucson, Arizona, 85741, United States

Location

Orange

Orange, California, 92868, United States

Location

Denver

Denver, Colorado, 80211, United States

Location

Pompano Beach

Pompano Beach, Florida, 33060, United States

Location

Jeffersonville

Jeffersonville, Indiana, 47130, United States

Location

Des Moines

Des Moines, Iowa, 50266, United States

Location

Wichita

Wichita, Kansas, 67226, United States

Location

Baltimore

Baltimore, Maryland, 21204, United States

Location

Troy

Troy, Michigan, 48084, United States

Location

Omaha

Omaha, Nebraska, 68130, United States

Location

Las Vegas

Las Vegas, Nevada, 89135, United States

Location

Brick

Brick, New Jersey, 08724, United States

Location

Albuquerque

Albuquerque, New Mexico, 87109, United States

Location

Albany

Albany, New York, 12208, United States

Location

Garden City

Garden City, New York, 11530, United States

Location

Plainview

Plainview, New York, 11803, United States

Location

Poughkeepsie

Poughkeepsie, New York, 12601, United States

Location

Syracuse

Syracuse, New York, 13210, United States

Location

Durham

Durham, North Carolina, 27710, United States

Location

Greensboro

Greensboro, North Carolina, 27403, United States

Location

Cincinnati

Cincinnati, Ohio, 45212, United States

Location

Middleburg Heights

Middleburg Heights, Ohio, 44130, United States

Location

Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Lancaster

Lancaster, Pennsylvania, 17604, United States

Location

Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States

Location

Nashville

Nashville, Tennessee, 37209, United States

Location

San Antonio

San Antonio, Texas, 78258, United States

Location

Camperdown

Camperdown, New South Wales, 2050, Australia

Location

Tweed Heads

Tweed Heads, New South Wales, 2485, Australia

Location

Wahroonga

Wahroonga, New South Wales, 2076, Australia

Location

Redcliffe

Redcliffe, Queensland, 4020, Australia

Location

Southport

Southport, Queensland, 4215, Australia

Location

Linz

Linz, 402, Austria

Location

Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Brussels

Brussels, 1200, Belgium

Location

Kortrijk

Kortrijk, 8500, Belgium

Location

Itabuna

Itabuna, Estado de Bahia, 45602-650, Brazil

Location

Salvador

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Salvador

Salvador, Estado de Bahia, 41820-021, Brazil

Location

Teresina

Teresina, Piauí, 64001-280, Brazil

Location

Natal

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

Ijuí

Ijuí, Rio Grande do Sul, 98700, Brazil

Location

Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

Porto Alegre

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Porto Alegre

Porto Alegre, Rio Grande do Sul, 90430-090, Brazil

Location

Joinville

Joinville, Santa Catarina, 89201-260, Brazil

Location

São José Do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Curitiba

Curitiba, 81520-060, Brazil

Location

Calgary

Calgary, Alberta, T2V4R6, Canada

Location

Vancouver

Vancouver, British Columbia, V5Z1M9, Canada

Location

Halifax

Halifax, Nova Scotia, B3H2Y9, Canada

Location

Hamilton

Hamilton, Ontario, L8N4A6, Canada

Location

London

London, Ontario, N6A4G5, Canada

Location

Montreal

Montreal, Quebec, H2X0A9, Canada

Location

Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

Quebec

Québec, G1R 3S3, Canada

Location

Nanjing

Nanjing, Jiangsu, 210008, China

Location

Changchun

Changchun, Jilin, 130021, China

Location

Shanghai

Shanghai, Shanghai Municipality, 020043, China

Location

Taiyuan

Taiyuan, Shanxi, 030001, China

Location

Beijing

Beijing, 100041, China

Location

Beijing

Beijing, 100050, China

Location

Beijing Shi

Beijing, 100730, China

Location

Chongqing

Chongqing, 400030, China

Location

Hangzhou

Hangzhou, 310003, China

Location

Lanzhou

Lanzhou, 730030, China

Location

Nanchang

Nanchang, 330006, China

Location

Shanghai

Shanghai, 200040, China

Location

Suzhou

Suzhou, 215004, China

Location

Alborg

Aalborg, DK-9000, Denmark

Location

Aarhus

Aarhus, 8200, Denmark

Location

Herlev

Herlev, 2730, Denmark

Location

Vejle

Vejle, DK-7100, Denmark

Location

Helsinki

Helsinki, FI-00029, Finland

Location

Seinajoki

Seinäjoki, FI-60220, Finland

Location

Tampere

Tampere, FI-33520, Finland

Location

Turku

Turku, FI-20520, Finland

Location

Strasbourg

Strasbourg, Bas-Rhin, 67091, France

Location

Pierre Benite

Pierre-Bénite, Rhone, 69495, France

Location

Creteil

Créteil, Val-de-Marne, 94010, France

Location

Lyon

Lyon, 69437, France

Location

Emmendingen

Emmendingen, Baden-Wurttemberg, 79312, Germany

Location

Planegg

Planegg, Bavaria, 82152, Germany

Location

Braunschweig

Braunschweig, Lower Saxony, 38100, Germany

Location

Dresden

Dresden, 01307, Germany

Location

Lubeck

Lübeck, 23538, Germany

Location

Munster

Münster, 48149, Germany

Location

Meldola

Meldola, Emilia-Romagna, 47014, Italy

Location

Rome

Rome, Lazio, 00152, Italy

Location

Cremona

Cremona, Lombardy, 26100, Italy

Location

Candiolo

Candiolo, Piedmont, 10060, Italy

Location

Orbassano

Orbassano, Piedmont, 10043, Italy

Location

Arezzo

Arezzo, Tuscany, 52100, Italy

Location

Milano

Milan, 20162, Italy

Location

Kanazawa-shi

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Yokohama

Yokohama, Kanagawa, 232-0024, Japan

Location

Sendai

Sendai, Miyagi, 9808574, Japan

Location

Sendai

Sendai, Miyagi, 9818563, Japan

Location

Osaka-sayama

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Suita

Suita, Osaka, 565-0871, Japan

Location

Bunkyō-Ku

Bunkyō-Ku, Tokyo, 113-8655, Japan

Location

Nakano-ku

Nakano-ku, Tokyo, 164-8541, Japan

Location

Sumida-ku

Sumida-ku, Tokyo, 130-8587, Japan

Location

Chiba

Chiba, 260-0801, Japan

Location

Fukuoka

Fukuoka, 812-0033, Japan

Location

Hiroshima

Hiroshima, 730-8518, Japan

Location

Kita-gun

Kita-ku, 761-0793, Japan

Location

Kyoto

Kyoto, 606-8507, Japan

Location

Maebashi

Maebashi, 371-8511, Japan

Location

Nagasaki

Nagasaki, 852-8501, Japan

Location

Osaka

Osaka, 541-8567, Japan

Location

Sapporo

Sapporo, 003-0804, Japan

Location

Tokyo

Tokyo, 285-8741, Japan

Location

Ube

Ube, 7558505, Japan

Location

Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

Location

Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Sneek

Sneek, 8601 ZK, Netherlands

Location

Christchurch

Christchurch, 8013, New Zealand

Location

Dunedin

Dunedin, 9016, New Zealand

Location

Hamilton

Hamilton, 3204, New Zealand

Location

Tauranga

Tauranga, 3112, New Zealand

Location

Lublin

Lublin, Lublin Voivodeship, 20-582, Poland

Location

Siedlce

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

Warszawa

Warsaw, Masovian Voivodeship, 02-797, Poland

Location

Gdynia

Gdynia, Pomeranian Voivodeship, 81-519, Poland

Location

Katowice

Katowice, 40611, Poland

Location

Bratislava

Bratislava, 851 05, Slovakia

Location

Kosice

Košice, 040 01, Slovakia

Location

Kosice

Košice, 041 91, Slovakia

Location

Martin

Martin, 036 59, Slovakia

Location

Nitra

Nitra, 949 01, Slovakia

Location

Poprad

Poprad, 058 45, Slovakia

Location

Presov

Prešov, 080 01, Slovakia

Location

Sala

Šaľa, 927 01, Slovakia

Location

Trencin

Trenčín, 911 01, Slovakia

Location

Goyang-Si

Goyang-si, Gyeonggido, 10408, South Korea

Location

Busan

Busan, 49241, South Korea

Location

Daegu

Daegu, 41404, South Korea

Location

Hwasun

Hwasun, 58128, South Korea

Location

Seoul

Seoul, 03080, South Korea

Location

Seoul

Seoul, 05505, South Korea

Location

Seoul

Seoul, 06273, South Korea

Location

Seoul

Seoul, 06351, South Korea

Location

A Coruna

A Coruña, A Coruna, 15706, Spain

Location

Oviedo

Oviedo, Principality of Asturias, 33011, Spain

Location

Barcelona

Barcelona, 08036, Spain

Location

Madrid

Madrid, 28007, Spain

Location

Madrid

Madrid, 28041, Spain

Location

Salamanca

Salamanca, 37007, Spain

Location

Valencia

Valencia, 46009, Spain

Location

Orebro

Örebro, Orebro Ian, SE-70185, Sweden

Location

Stockholm

Stockholm, Sodermandlands Ian, SE-17176, Sweden

Location

Uppsala

Uppsala, Uppsala County, SE-751-85, Sweden

Location

Malmo

Malmo, SE-20502, Sweden

Location

Kaohsiung City

Kaohsiung City, 807, Taiwan

Location

Taipei

Taipei, 100, Taiwan

Location

Taipei

Taipei, 111, Taiwan

Location

Taipei

Taipei, 11490, Taiwan

Location

Exeter

Exeter, Devon, EX2 5DW, United Kingdom

Location

Scunthorpe

Scunthorpe, North Lincolnshire, DN157BH, United Kingdom

Location

Nottingham

Nottingham, NG5 1PB, United Kingdom

Location

Rhyl

Rhyl, LL18 5UJ, United Kingdom

Location

Related Publications (3)

• Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B; HERO Study Investigators. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187-2196. doi: 10.1056/NEJMoa2004325. Epub 2020 May 29.

  PMID: 32469183 BACKGROUND

• Shore ND, Mehlhaff BA, Cookson MS, Saltzstein DR, Tutrone R, Brown B, Lu S, Fallick M, Hanson S, Saad F. Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer. Adv Ther. 2023 Nov;40(11):4919-4927. doi: 10.1007/s12325-023-02634-7. Epub 2023 Sep 15.

  PMID: 37713020 DERIVED

• Shore ND, Sutton J. Plain language summary of the HERO study comparing relugolix with leuprolide for men with advanced prostate cancer. Future Oncol. 2022 Jul;18(21):2575-2584. doi: 10.2217/fon-2022-0172. Epub 2022 May 19.

  PMID: 35587650 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Clinical Trials at Myovant
• Organization: Myovant Sciences GmbH

ClinicalTrials@Myovant.com

650-278-8743

Study Officials

• Myovant Medical Monitor

  Myovant Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 21, 2017
• Study Start: April 18, 2017
• Primary Completion: October 25, 2019
• Study Completion: November 26, 2021
• Last Updated: January 18, 2022
• Results First Posted: March 25, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); SL (9); FI (4); JP (20); BE (3); FR (4); IT (7); KR (8); DE (6); SE (4); NZ (4); ES (7); CN (13); US (27); PL (5); DK (4); BR (12); NL (3); CA (8); GB (4); TW (4)