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New drug combo slows prostate cancer spread in large trial

NCT ID NCT02677896

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large phase 3 trial tested whether adding enzalutamide (Xtandi) to standard hormone therapy (ADT) helps men with metastatic hormone-sensitive prostate cancer. Over 1,100 participants received either enzalutamide plus ADT or a placebo plus ADT. The main goal was to see how long until the cancer worsened on scans. Results showed that the combination delayed cancer progression compared to hormone therapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enzalutamide (Xtandi)
What this could lead to
If successful, this combination could become a standard treatment to delay cancer growth and extend life for men with metastatic hormone-sensitive prostate cancer.
What could go wrong
This trial is completed and results are published, so the main risk is that benefits may not apply to all patients or that side effects (e.g., fatigue, hot flashes) may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,150 people

The number who actually took part.

Started

Mar 2016

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject is considered an adult according to local regulation at the time of signing informed consent. * Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology. * Subject has metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan (for soft tissue). Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible. * Once randomized at day 1, subject must maintain ADT with an LHRH agonist or antagonist during study treatment or have a history of bilateral orchiectomy (i.e., medical or surgical castration). * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Inclusion Criteria for Open-Label Extension: * Subject received randomized double-blind treatment in ARCHES * Subject has not met any of the discontinuation criteria in the main ARCHES protocol * Subject is willing to maintain ADT with LHRH agonist or antagonist or has had a bilateral orchiectomy. * Subject is able to swallow enzalutamide capsules whole and to comply with study requirements throughout the study * Subject and subject's female partner agree to follow contraception and sperm donation requirements in main protocol Exclusion Criteria: * Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted): * Up to 3 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1, with no radiographic evidence of disease progression or rising PSA levels prior to day 1; * Subject may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to day 1; * Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of day 1 and no evidence of disease progression during or after the completion of docetaxel therapy; * Up to 6 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to day 1; * Prior ADT given for \< 39 months in duration and \> 9 months before randomization as neoadjuvant/adjuvant therapy. * Subject had a major surgery within 4 weeks prior to day 1. * Subject received treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks prior to day 1. * Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks prior to day 1. * Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1, intended for the treatment of prostate cancer. * Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1. * Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for the treatment of prostate cancer or participation in a clinical study of an investigational agent that inhibits the AR or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201). * Subject has known or suspected brain metastasis or active leptomeningeal disease. * Subject has absolute neutrophil count \< 1500/μL, platelet count \< 100000/μL or hemoglobin \< 10 g/dL (6.2 mmol/L). * Subject has total bilirubin (TBL) ≥ 1.5 x the upper limit of normal (ULN) (except subjects with documented Gilbert's disease), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x the ULN . * Subject has creatinine \> 2 mg/dL (177 μmol/L). * Subject has albumin \< 3.0 g/dL (30 g/L). * Subject has a history of seizure or any condition that may predispose to seizure. * Subject has history of loss of consciousness or transient ischemic attack within 12 months prior to day 1. * Subject has clinically significant cardiovascular disease. * Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis Exclusion Criteria for Open-Label Extension: * Subject has taken commercially available enzalutamide (Xtandi). * Subject's disease has progressed radiographically during the double-blind period of the study and treatment with study drug was stopped prior to study-wide unblinding. (Note: Subjects who progressed radiographically while in the double-blind portion of the study and continued treatment per protocol are allowed to participate in the open label extension.) * After study-wide unblinding, subject has started any new investigational agent or anti-neoplastic therapy intended to treat prostate cancer * Subject has any clinically significant disorder or condition including excessive alcohol or drug abuse, or secondary malignancy, which may interfere with study participation * Subject has current or previously treated brain metastasis or active leptomeningeal disease * Subject has a history of seizure or any condition that may increase the risk of seizure

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone sensitive prostate cancer

Contacts and locations

Locations

  • Site AR54002

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Site AR54007

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Site AR54010

    Buenos Aires, C1180AAX, Argentina

  • Site AU61001

    Woodville South, South Australia, 5011, Australia

  • Site AU61004

    Ballarat, Victoria, Australia

  • Site AU61006

    Sydney, New South Wales, Australia

  • Site AU61007

    St Leonards, New South Wales, 2065, Australia

  • Site AU61008

    St Albans, Victoria, Australia

  • Site AU61009

    Tweed Heads, New South Wales, 2485, Australia

  • Site AU61013

    Waratah, New South Wales, 2298, Australia

  • Site AU61015

    Clayton, Victoria, Australia

  • Site AU61016

    Camperdown, New South Wales, 2050, Australia

  • Site AU61017

    Parkville, Victoria, Australia

  • Site BE32001

    Mons, Hainaut, Belgium

  • Site BE32005

    Kortrijk, West-Vlaanderen, Belgium

  • Site BE32007

    Yvoir, Belgium

  • Site BE32008

    Liège, Belgium

  • Site BE32012

    Ghent, Oost-Vlaanderen, Belgium

  • Site CA15003

    Kelowna, British Columbia, V1W 4V5, Canada

  • Site CA15004

    Montreal, Quebec, H3T1E2, Canada

  • Site CA15010

    Brampton, Ontario, L6T 4S5, Canada

  • Site CA15013

    Oakville, Ontario, L6H 3P1, Canada

  • Site CA15016

    Edmonton, Alberta, T6G 1Z2, Canada

  • Site CA15020

    Toronto, Ontario, M5G 2M9, Canada

  • Site CA15021

    Kingston, Ontario, K7L 2V7, Canada

  • Site CA15022

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Site CA15023

    Granby, Quebec, J2G 8Z9, Canada

  • Site CA15024

    Abbotsford British Columbia, British Columbia, V2S 3N6, Canada

  • Site CL56001

    Santiago, RM, Chile

  • Site CL56002

    Temuco, Araucania, Chile

  • Site CL56003

    Santiago, Chile

  • Site CL56004

    Reñaca, Viña Del Mar, Chile

  • Site CL56005

    Viña del Mar, Valparaiso, Chile

  • Site CL56007

    Providencia, Santiago Metropolitan, Chile

  • Site DE49002

    Freiburg im Breisgau, Baden-Wurttemberg, Germany

  • Site DE49004

    Nürtingen, Baden-Wurttemberg, Germany

  • Site DE49005

    Bonn, 53111, Germany

  • Site DE49013

    Heidelberg, 69120, Germany

  • Site DE49014

    Hamburg, 20246, Germany

  • Site DK45001

    Odense C, Denmark

  • Site DK45002

    Copenhagen, Hovestaden, Denmark

  • Site DK45003

    Herlev, Denmark

  • Site DK45004

    Aalborg, North Denmark, Denmark

  • Site DK45005

    Aarhus, Central Jutland, Denmark

  • Site DK45008

    Holstebro, Central Jutland, Denmark

  • Site ES34001

    Ávila, Spain

  • Site ES34004

    Madrid, Spain

  • Site ES34006

    Pamplona, Navarre, Spain

  • Site ES34007

    Barcelona, Spain

  • Site ES34010

    Sabadell, Barcelona, Spain

  • Site ES34011

    Salamanca, A Coruña, Spain

  • Site ES34012

    Barcelona, Catalonia, Spain

  • Site ES34013

    Valencia, Valencia, Spain

  • Site ES34014

    Barcelona, Catalonia, Spain

  • Site ES34019

    Madrid, Spain

  • Site ES34020

    Oviedo, Principality of Asturias, Spain

  • Site FI35801

    Tampere, Oulun Laani, Finland

  • Site FI35802

    Helsinki, Etelä-Suomen Lääni, Finland

  • Site FI35803

    Seinäjoki, Länsi-Suomen Lääni, Finland

  • Site FI35804

    Pori, Länsi-Suomen Lääni, Finland

  • Site FI35805

    Oulu, Finland

  • Site FI35806

    Jakobstad, Finland

  • Site FI35807

    Turku, Finland

  • Site FR33001

    Pierre-Bénite, France

  • Site FR33003

    Créteil, Val-de-Marne, 94010, France

  • Site FR33005

    La Roche-sur-Yon, France

  • Site FR33006

    Bordeaux, France

  • Site FR33007

    Lyon, France

  • Site FR33009

    Quimper, France

  • Site FR33010

    Angers, Maine-et-Loire, France

  • Site FR33011

    Nîmes, France

  • Site FR33012

    Lille, France

  • Site FR33013

    Saint-Mandé, France

  • Site FR33014

    Caen, 14076, France

  • Site FR33015

    Le Mans, France

  • Site GB44002

    Withington, Manchester, United Kingdom

  • Site IL97201

    Kfar Saba, Central District, Israel

  • Site IL97202

    Haifa, Israel

  • Site IL97205

    Haifa, Israel

  • Site IL97206

    Jerusalem, Israel

  • Site IL97210

    Beersheba, Israel

  • Site IL97211

    Ẕerifin, Central District, Israel

  • Site IT39003

    Milan, Lombardy, Italy

  • Site IT39004

    Cremona, Lombardy, Italy

  • Site IT39005

    Meldola, Emilia-Romagna, Italy

  • Site IT39006

    Padova, Veneto, Italy

  • Site IT39007

    Novara, Piedmont, Italy

  • Site IT39008

    Pisa, Tuscany, Italy

  • Site IT39009

    Candiolo, 10060, Italy

  • Site IT39011

    Trento, Trentino-Alto Adige, 38100, Italy

  • Site IT39012

    Milan, Lombardy, Italy

  • Site JP81001

    Maebashi, Gunma, Japan

  • Site JP81002

    Chiba, Japan

  • Site JP81003

    Sakura, Chiba, Japan

  • Site JP81004

    Koto-ku, Tokyo, Japan

  • Site JP81005

    Shinjuku-ku, Tokyo, Japan

  • Site JP81006

    Bunkyo-ku, Tokyo, Japan

  • Site JP81007

    Yokohama, Kanagawa, Japan

  • Site JP81008

    Kyoto, Japan

  • Site JP81010

    Abeno-ku, Osaka, Japan

  • Site JP81011

    Chuo-ku, Osaka, Japan

  • Site JP81012

    Sayama, Osaka, Japan

  • Site JP81013

    Kita-gun, Kagawa-ken, Japan

  • Site JP81014

    Fukuoka, Japan

  • Site JP81015

    Fukuoka, Japan

  • Site JP81016

    Sendai, Miyagi, Japan

  • Site JP81017

    Ube, Yamaguchi, Japan

  • Site JP81018

    Nagasaki, Japan

  • Site JP81019

    Yamagata, Japan

  • Site JP81020

    Niigata, Japan

  • Site KR82001

    Seoul, South Korea

  • Site KR82002

    Seoul, South Korea

  • Site KR82003

    Seoul, South Korea

  • Site KR82004

    Incheon, South Korea

  • Site KR82007

    Busan, South Korea

  • Site KR82008

    Seongnam-si, Gyeonggi-do, South Korea

  • Site NL31002

    Sneek, Provincie Friesland, Netherlands

  • Site NL31003

    Nijmegen, Gelderland, Netherlands

  • Site NL31005

    Eindhoven, North Brabant, Netherlands

  • Site NL31006

    Rotterdam, South Holland, Netherlands

  • Site NL31007

    Nijmegen, Gelderland, Netherlands

  • Site NL31008

    Amsterdam, North Holland, Netherlands

  • Site NL31009

    Zwolle, Overijssel, Netherlands

  • Site NL31010

    Alkmaar, North Holland, Netherlands

  • Site NZ64002

    Dunedin, South Island, New Zealand

  • Site NZ64003

    Tauranga, Bay of Plenty, New Zealand

  • Site NZ64004

    Hamilton, New Zealand

  • Site NZ64005

    Nelson, Tasman District, New Zealand

  • Site NZ64008

    Kensington, Northland, New Zealand

  • Site PL48001

    Mysłowice, Poland

  • Site PL48003

    Wroclaw, Lower Silesian Voivodeship, Poland

  • Site PL48005

    Gdansk, Pomeranian Voivodeship, Poland

  • Site PL48007

    Krakow, Lesser Poland Voivodeship, Poland

  • Site PL48010

    Słupsk, Pomeranian Voivodeship, Poland

  • Site PL48011

    Warsaw, Masovian Voivodeship, Poland

  • Site RO40002

    Floreşti, Cluj, Romania

  • Site RO40003

    Bucharest, Romania

  • Site RO40006

    Bucharest, Romania

  • Site RO40007

    Brasov, Romania

  • Site RO40008

    Cluj-Napoca, Cluj, Romania

  • Site RO40009

    Cluj-Napoca, Cluj, Romania

  • Site RO40011

    Timișoara, Timiș County, Romania

  • Site RU70001

    Moscow, Russia

  • Site RU70003

    Moscow, Russia

  • Site RU70005

    Penza, Russia

  • Site RU70006

    Omsk, Russia

  • Site RU70007

    Saint Petersburg, Russia

  • Site RU70008

    Saint Petersburg, Russia

  • Site RU70009

    Saint Petersburg, Russia

  • Site RU70012

    Saint Petersburg, Russia

  • Site RU70013

    Ivanovo, Russia

  • Site RU70014

    Moscow, Russia

  • Site RU70016

    Saint Petersburg, Russia

  • Site SE46001

    Malmö, Skåne County, Sweden

  • Site SE46002

    Örebro, Orebro Län, Sweden

  • Site SE46004

    Sundsvall, Västernorrland County, Sweden

  • Site SE46006

    Stockholm, Södermanland County, Sweden

  • Site SE46007

    Gothenburg, Västra Götaland County, Sweden

  • Site SK42101

    Poprad, Slovakia

  • Site SK42102

    Michalovce, Slovakia

  • Site SK42103

    Nitra, Slovakia

  • Site SK42106

    Žilina, 012 07, Slovakia

  • Site SK42107

    Trenčín, Slovakia

  • Site SK42109

    Košice, Slovakia

  • Site SK42110

    Bratislava, Slovakia

  • Site TW88601

    Kaohsiung City, 112, Taiwan

  • Site TW88605

    Taipei, Taiwan

  • Site TW88606

    Taichung, 40705, Taiwan

  • Site TW88607

    Taoyuan, 333, Taiwan

  • Site US10002

    Burien, Washington, 98166, United States

  • Site US10004

    Dallas, Texas, 75390-9110, United States

  • Site US10007

    Anchorage, Alaska, 99503, United States

  • Site US10008

    Tucson, Arizona, 85741, United States

  • Site US10009

    Concord, North Carolina, 28025, United States

  • Site US10011

    Lancaster, Pennsylvania, 17604, United States

  • Site US10012

    Myrtle Beach, South Carolina, 29572, United States

  • Site US10013

    Seattle, Washington, 98101, United States

  • Site US10014

    Durham, North Carolina, 27710, United States

  • Site US10015

    Chicago, Illinois, 60637, United States

  • Site US10016

    Homewood, Alabama, 35209, United States

  • Site US10017

    Towson, Maryland, 21204, United States

  • Site US10018

    Lawrenceville, New Jersey, 08648, United States

  • Site US10020

    West Des Moines, Iowa, 50266, United States

  • Site US10025

    Newburgh, New York, 12550, United States

  • Site US10026

    Santa Rosa, California, 95403, United States

  • Site US10028

    Wenatchee, Washington, 98801, United States

  • Site US10029

    Syracuse, New York, 13210, United States

  • Site US10034

    Fountain Valley, California, 92708, United States

  • Site US10035

    Aurora, Colorado, 80045, United States

  • Site US10036

    Omaha, Nebraska, 68114, United States

  • Site US10040

    Virginia Beach, Virginia, 23462, United States

  • Site US10043

    Springfield, Illinois, 62703, United States

  • Site US10044

    Middleburg Heights, Ohio, 44130, United States

  • Site US10045

    Jeffersonville, Indiana, 47130, United States

  • Site US10046

    Dallas, Texas, 75231, United States

  • Site US10048

    St. Petersburg, Florida, 33710, United States

  • Site US10050

    Denver, Colorado, 80220, United States

  • Site US10054

    Thomasville, Georgia, 31792, United States

  • Site US10055

    Kansas City, Kansas, 66160-7233, United States

  • Site US10056

    La Jolla, California, 92093, United States

  • Site US10059

    Nashville, Tennessee, 37208, United States

  • Site US10060

    Greenville, North Carolina, 27834, United States

  • Site US10068

    Charlotte, North Carolina, 28207, United States

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