AzTrials
AzTrials

Metastatic Hormone Sensitive Prostate CancerPhase 3ARCHESNCT02677896

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

A Phase 3 study testing Enzalutamide in people with Metastatic Hormone Sensitive Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 203 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,150 participants
Where
203 sitesin 24 countries
Study dates
9 Mar 2016to 31 Jul 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Subject received randomized double-blind treatment in ARCHES
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  • 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

Who cannot join

  • 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.
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  • 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
  • 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

Trial locations and contacts

203 sites in 24 countries.

203 sites in 24 countries

United States34 sites

  • Site US10007

    Anchorage, Alaska, 99503

  • Site US10035

    Aurora, Colorado, 80045

  • Site US10002

    Burien, Washington, 98166

  • Site US10068

    Charlotte, North Carolina, 28207

  • Site US10015

    Chicago, Illinois, 60637

  • Site US10009

    Concord, North Carolina, 28025

  • Site US10046

    Dallas, Texas, 75231

  • Site US10004

    Dallas, Texas, 75390-9110

  • Site US10050

    Denver, Colorado, 80220

  • Site US10014

    Durham, North Carolina, 27710

  • Site US10034

    Fountain Valley, California, 92708

  • Site US10060

    Greenville, North Carolina, 27834

  • Site US10016

    Homewood, Alabama, 35209

  • Site US10045

    Jeffersonville, Indiana, 47130

  • Site US10055

    Kansas City, Kansas, 66160-7233

  • Site US10056

    La Jolla, California, 92093

  • Site US10011

    Lancaster, Pennsylvania, 17604

  • Site US10018

    Lawrenceville, New Jersey, 08648

  • Site US10044

    Middleburg Heights, Ohio, 44130

  • Site US10012

    Myrtle Beach, South Carolina, 29572

  • Site US10059

    Nashville, Tennessee, 37208

  • Site US10025

    Newburgh, New York, 12550

  • Site US10036

    Omaha, Nebraska, 68114

  • Site US10026

    Santa Rosa, California, 95403

  • Site US10013

    Seattle, Washington, 98101

  • Site US10043

    Springfield, Illinois, 62703

  • Site US10048

    St. Petersburg, Florida, 33710

  • Site US10029

    Syracuse, New York, 13210

  • Site US10054

    Thomasville, Georgia, 31792

  • Site US10017

    Towson, Maryland, 21204

  • Site US10008

    Tucson, Arizona, 85741

  • Site US10040

    Virginia Beach, Virginia, 23462

  • Site US10028

    Wenatchee, Washington, 98801

  • Site US10020

    West Des Moines, Iowa, 50266

Other trials in United States

Japan19 sites

  • Site JP81010

    Abeno-ku, Osaka

  • Site JP81006

    Bunkyo-ku, Tokyo

  • Site JP81002

    Chiba

  • Site JP81011

    Chuo-ku, Osaka

  • Site JP81014

    Fukuoka

  • Site JP81015

    Fukuoka

  • Site JP81013

    Kita-gun, Kagawa-ken

  • Site JP81004

    Koto-ku, Tokyo

  • Site JP81008

    Kyoto

  • Site JP81001

    Maebashi, Gunma

  • Site JP81018

    Nagasaki

  • Site JP81020

    Niigata

  • Site JP81003

    Sakura, Chiba

  • Site JP81012

    Sayama, Osaka

  • Site JP81016

    Sendai, Miyagi

  • Site JP81005

    Shinjuku-ku, Tokyo

  • Site JP81017

    Ube, Yamaguchi

  • Site JP81019

    Yamagata

  • Site JP81007

    Yokohama, Kanagawa

Other trials in Japan

France12 sites

  • Site FR33010

    Angers, Maine-et-Loire

  • Site FR33006

    Bordeaux

  • Site FR33014

    Caen, 14076

  • Site FR33003

    Créteil, Val-de-Marne, 94010

  • Site FR33005

    La Roche-sur-Yon

  • Site FR33015

    Le Mans

  • Site FR33012

    Lille

  • Site FR33007

    Lyon

  • Site FR33011

    Nîmes

  • Site FR33001

    Pierre-Bénite

  • Site FR33009

    Quimper

  • Site FR33013

    Saint-Mandé

Other trials in France

Russia11 sites

  • Site RU70013

    Ivanovo

  • Site RU70001

    Moscow

  • Site RU70003

    Moscow

  • Site RU70014

    Moscow

  • Site RU70006

    Omsk

  • Site RU70005

    Penza

  • Site RU70007

    Saint Petersburg

  • Site RU70008

    Saint Petersburg

  • Site RU70009

    Saint Petersburg

  • Site RU70012

    Saint Petersburg

  • Site RU70016

    Saint Petersburg

Other trials in Russia

Spain11 sites

  • Site ES34001

    Ávila

  • Site ES34012

    Barcelona, Catalonia

  • Site ES34014

    Barcelona, Catalonia

  • Site ES34007

    Barcelona

  • Site ES34004

    Madrid

  • Site ES34019

    Madrid

  • Site ES34020

    Oviedo, Principality of Asturias

  • Site ES34006

    Pamplona, Navarre

  • Site ES34010

    Sabadell, Barcelona

  • Site ES34011

    Salamanca, A Coruña

  • Site ES34013

    Valencia, Valencia

Other trials in Spain

Australia10 sites

  • Site AU61004

    Ballarat, Victoria

  • Site AU61016

    Camperdown, New South Wales, 2050

  • Site AU61015

    Clayton, Victoria

  • Site AU61017

    Parkville, Victoria

  • Site AU61008

    St Albans, Victoria

  • Site AU61007

    St Leonards, New South Wales, 2065

  • Site AU61006

    Sydney, New South Wales

  • Site AU61009

    Tweed Heads, New South Wales, 2485

  • Site AU61013

    Waratah, New South Wales, 2298

  • Site AU61001

    Woodville South, South Australia, 5011

Other trials in Australia

Canada10 sites

  • Site CA15024

    Abbotsford British Columbia, British Columbia, V2S 3N6

  • Site CA15010

    Brampton, Ontario, L6T 4S5

  • Site CA15016

    Edmonton, Alberta, T6G 1Z2

  • Site CA15023

    Granby, Quebec, J2G 8Z9

  • Site CA15003

    Kelowna, British Columbia, V1W 4V5

  • Site CA15022

    Kelowna, British Columbia, V1Y 5L3

  • Site CA15021

    Kingston, Ontario, K7L 2V7

  • Site CA15004

    Montreal, Quebec, H3T1E2

  • Site CA15013

    Oakville, Ontario, L6H 3P1

  • Site CA15020

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy9 sites

  • Site IT39009

    Candiolo, 10060

  • Site IT39004

    Cremona, Lombardy

  • Site IT39005

    Meldola, Emilia-Romagna

  • Site IT39003

    Milan, Lombardy

  • Site IT39012

    Milan, Lombardy

  • Site IT39007

    Novara, Piedmont

  • Site IT39006

    Padova, Veneto

  • Site IT39008

    Pisa, Tuscany

  • Site IT39011

    Trento, Trentino-Alto Adige, 38100

Other trials in Italy

Netherlands8 sites

  • Site NL31010

    Alkmaar, North Holland

  • Site NL31008

    Amsterdam, North Holland

  • Site NL31005

    Eindhoven, North Brabant

  • Site NL31003

    Nijmegen, Gelderland

  • Site NL31007

    Nijmegen, Gelderland

  • Site NL31006

    Rotterdam, South Holland

  • Site NL31002

    Sneek, Provincie Friesland

  • Site NL31009

    Zwolle, Overijssel

Other trials in Netherlands

Finland7 sites

  • Site FI35802

    Helsinki, Etelä-Suomen Lääni

  • Site FI35806

    Jakobstad

  • Site FI35805

    Oulu

  • Site FI35804

    Pori, Länsi-Suomen Lääni

  • Site FI35803

    Seinäjoki, Länsi-Suomen Lääni

  • Site FI35801

    Tampere, Oulun Laani

  • Site FI35807

    Turku

Other trials in Finland

Romania7 sites

  • Site RO40007

    Brasov

  • Site RO40003

    Bucharest

  • Site RO40006

    Bucharest

  • Site RO40008

    Cluj-Napoca, Cluj

  • Site RO40009

    Cluj-Napoca, Cluj

  • Site RO40002

    Floreşti, Cluj

  • Site RO40011

    Timișoara, Timiș County

Other trials in Romania

Slovakia7 sites

  • Site SK42110

    Bratislava

  • Site SK42109

    Košice

  • Site SK42102

    Michalovce

  • Site SK42103

    Nitra

  • Site SK42101

    Poprad

  • Site SK42107

    Trenčín

  • Site SK42106

    Žilina, 012 07

Other trials in Slovakia

Chile6 sites

  • Site CL56007

    Providencia, Santiago Metropolitan

  • Site CL56004

    Reñaca, Viña Del Mar

  • Site CL56001

    Santiago, RM

  • Site CL56003

    Santiago

  • Site CL56002

    Temuco, Araucania

  • Site CL56005

    Viña del Mar, Valparaiso

Other trials in Chile

Denmark6 sites

  • Site DK45004

    Aalborg, North Denmark

  • Site DK45005

    Aarhus, Central Jutland

  • Site DK45002

    Copenhagen, Hovestaden

  • Site DK45003

    Herlev

  • Site DK45008

    Holstebro, Central Jutland

  • Site DK45001

    Odense C

Other trials in Denmark

Israel6 sites

  • Site IL97210

    Beersheba

  • Site IL97202

    Haifa

  • Site IL97205

    Haifa

  • Site IL97206

    Jerusalem

  • Site IL97201

    Kfar Saba, Central District

  • Site IL97211

    Tsrifin, Central District

Other trials in Israel

Poland6 sites

  • Site PL48005

    Gdansk, Pomeranian Voivodeship

  • Site PL48007

    Krakow, Lesser Poland Voivodeship

  • Site PL48001

    Mysłowice

  • Site PL48010

    Słupsk, Pomeranian Voivodeship

  • Site PL48011

    Warsaw, Masovian Voivodeship

  • Site PL48003

    Wroclaw, Lower Silesian Voivodeship

Other trials in Poland

South Korea6 sites

  • Site KR82007

    Busan

  • Site KR82004

    Incheon

  • Site KR82008

    Seongnam-si, Gyeonggi-do

  • Site KR82001

    Seoul

  • Site KR82002

    Seoul

  • Site KR82003

    Seoul

Other trials in South Korea

Belgium5 sites

  • Site BE32012

    Ghent, Oost-Vlaanderen

  • Site BE32005

    Kortrijk, West-Vlaanderen

  • Site BE32008

    Liège

  • Site BE32001

    Mons, Hainaut

  • Site BE32007

    Yvoir

Other trials in Belgium

Germany5 sites

  • Site DE49005

    Bonn, 53111

  • Site DE49002

    Freiburg im Breisgau, Baden-Wurttemberg

  • Site DE49014

    Hamburg, 20246

  • Site DE49013

    Heidelberg, 69120

  • Site DE49004

    Nürtingen, Baden-Wurttemberg

Other trials in Germany

New Zealand5 sites

  • Site NZ64002

    Dunedin, South Island

  • Site NZ64004

    Hamilton

  • Site NZ64008

    Kensington, Northland

  • Site NZ64005

    Nelson, Tasman District

  • Site NZ64003

    Tauranga, Bay of Plenty

Other trials in New Zealand

Sweden5 sites

  • Site SE46007

    Gothenburg, Västra Götaland County

  • Site SE46001

    Malmö, Skåne County

  • Site SE46002

    Örebro, Orebro Län

  • Site SE46006

    Stockholm, Södermanland County

  • Site SE46004

    Sundsvall, Västernorrland County

Other trials in Sweden

Taiwan4 sites

  • Site TW88601

    Kaohsiung City, 112

  • Site TW88606

    Taichung, 40705

  • Site TW88605

    Taipei

  • Site TW88607

    Taoyuan, 333

Other trials in Taiwan

Argentina3 sites

  • Site AR54010

    Buenos Aires, C1180AAX

  • Site AR54002

    Rosario, Santa Fe Province, S2000DSV

  • Site AR54007

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

United Kingdom1 site

  • Site GB44002

    Withington, Manchester

Other trials in United Kingdom

About this study

Official title: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

Read the detailed description

Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over placebo when added to ADT as assessed by the primary endpoint of rPFS, subjects were eligible to transition to an open-label portion of the study.

Being tested
Enzalutamide, Placebo
Keywords
Androgen Deprivation Therapy (ADT), Metastatic hormone sensitive prostate cancer, Xtandi, Enzalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02677896
Study groupRoleWhat they receive
Enzalutamide + Androgen Deprivation Therapy (ADT)ExperimentalParticipants received 160 mg enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Receives: Drug: Enzalutamide
Placebo + Androgen Deprivation Therapy (ADT)Placebo comparatorParticipants received matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Receives: Drug: Placebo
Placebo followed by EnzalutamideExperimentalEligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
Receives: Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria

    rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.

    Measured: From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)

  2. rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria

    rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as "not evaluable (NE)," rPFS was censored on the date of randomization.

    Measured: From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)

Secondary outcomes (10)

  1. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive. OS was analyzed using Kaplan-Meier estimates.

    Measured: From randomization to death due to any cause (maximum duration was 58.6 months)

  2. Time to Prostate Specific Antigen (PSA) Progression

    Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).

    Measured: From the date of randomization to the first observation of PSA progression (maximum duration was 26.6 months)

  3. Time to Start of New Antineoplastic Therapy

    In participants with a new antineoplastic therapy initiated for prostate cancer after randomization, time to start of a new antineoplastic therapy was defined as the time interval from randomization to the date of the first dose administration of the first antineoplastic therapy. In participants with no new antineoplastic therapy initiated for prostate cancer after randomization, time to start of new antineoplastic therapy was censored on the last visit date or the date of randomization, whichever occurred last. Time to start of new antineoplastic therapy was analyzed using Kaplan-Meier estimates.

    Measured: From randomization to the date of the first dose administration of the first antineoplastic therapy (maximum duration was 58.6 months)

  4. PSA Undetectable Rate

    The PSA undetectable rate was defined as the percentage of participants with undetectable (< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.

    Measured: From baseline to detectable PSA values (maximum duration was 26.6 months)

  5. Objective Response Rate (ORR)

    The ORR was calculated as the percentage of participants who achieved a completed response (CR) or a partial response (PR) (unconfirmed responses) in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by ICR.

    Measured: From date of randomization up to 26.6 months

  6. Time to Deterioration in Urinary Symptoms

    In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.

    Measured: From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)

  7. Time to First Symptomatic Skeletal Event (SSE)

    Time to first SSE was calculated as the time from randomization to the occurrence of the first SSE. An SSE was defined as radiation to bone, surgery to bone, clinically apparent pathological bone fracture, or spinal cord compression. In participants with no SSE, time to SSE was censored on the last visit date or the date of randomization, whichever occurred last.

    Measured: From randomization to the occurrence of the first SSE (maximum duration was 26.6 months)

  8. Time to Castration Resistance

    Time to castration resistance was calculated as the time from randomization to the first castration-resistant event. A castration resistance event was defined as any of the following in the presence of castrate levels of testosterone (< 50 ng/dL): radiographic disease progression, PSA progression or SSE, whichever occurred first. In participants with no documented castration resistance event, the time to castration resistance was censored on the latest date from: the date of last radiologic assessment, the last PSA sample taken prior to the start of any new prostate cancer therapy and prior to 2 or more consecutive missed PSA assessments (if applicable), and the last visit date performed.

    Measured: From randomization to the first castration-resistant event (maximum duration was 26.6 months)

  9. Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Time to deterioration of QoL was calculated as the time interval from the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score was recorded. The FACT-P consists of 27 core items that assess participant function in 4 domains and 12 prostate cancer-related items grouped into 5 subscales as follows: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and prostate cancer subscale. Each item is rated on a 0 to 4 Likert-type scale. The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0 to 156), where high score represent better quality of life. In participants without FACT-P progression, the time to deterioration of QoL was censored on the date of the last FACT-P total score was calculable.

    Measured: From the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score (maximum duration was 26.6 months)

  10. Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)

    Time to pain progression was defined as time from randomization to the first pain progression event. Pain progression was defined as an increase of ≥ 30% from baseline in the average BPI-SF pain severity score. BPI-SF contains 9 questions with rating scales from 0 (no pain/no interference) to 10 (worst pain/interferes completely). Total score was calculated as the average of each question. Higher scores represent a higher level of pain or interference. In participants with no pain progression event, time to pain progression was censored on the last visit date where BPI-SF was collected.

    Measured: From randomization to the first pain progression event (maximum duration was 26.6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2016 (estimated)
  2. Study start9 Mar 2016
  3. Primary completion14 Oct 2018
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02677896
Sponsor's protocol ID
9785-CL-0335
Other IDs
2015-003869-28, 2015
Acronym
ARCHES
Status last verified
Oct 2025
First submitted
5 Feb 2016
Last updated
24 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986. doi: 10.1200/JCO.19.00799. Epub 2019 Jul 22.

    PubMed 31329516

  • Armstrong AJ, Azad AA, Iguchi T, Stenzl A, Mottet N, Russell D, Rosales M, Haas GP, Saad F, Hussain M, Sternberg CN. Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide. J Clin Oncol. 2026 May 10;44(14):1309-1322. doi: 10.1200/JCO-24-02829. Epub 2026 Mar 27.

    PubMed 41894648

  • Azad AA, Petrylak DP, Iguchi T, Shore ND, Villers A, Gomez-Veiga F, Alcaraz A, Alekseev B, Szmulewitz RZ, Holzbeierlein J, Rosbrook B, Ma J, Zohren F, El-Chaar NN, Haas GP, Stenzl A, Armstrong AJ. Enzalutamide and Prostate-Specific Antigen Levels in Metastatic Prostate Cancer: A Secondary Analysis of the ARCHES Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258751. doi: 10.1001/jamanetworkopen.2025.8751.

    PubMed 40332939

  • Armstrong AJ, Azad AA, Conduit C, Haas GP, Bland C, Davis ID. Enzalutamide in metastatic hormone-sensitive prostate cancer: A plain language summary of the ARCHES and ENZAMET follow-up studies. Future Oncol. 2025 Jan;21(1):15-24. doi: 10.1080/14796694.2024.2408101. Epub 2024 Oct 15.

    PubMed 39404227

  • Armstrong AJ, Iguchi T, Azad AA, Villers A, Alekseev B, Petrylak DP, Szmulewitz RZ, Alcaraz A, Shore ND, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas GP, Gourgiotti G, El-Chaar N, Stenzl A. The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES. Eur Urol. 2023 Aug;84(2):229-241. doi: 10.1016/j.eururo.2023.04.002. Epub 2023 May 12.

    PubMed 37179240

  • Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

    PubMed 35731340

  • Armstrong AJ, Azad AA, Iguchi T, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore ND, Gomez-Veiga F, Rosbrook B, Zohren F, Yamada S, Haas GP, Stenzl A. Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2022 May 20;40(15):1616-1622. doi: 10.1200/JCO.22.00193. Epub 2022 Apr 14.

    PubMed 35420921

  • Stenzl A, Dunshee C, De Giorgi U, Alekseev B, Iguchi T, Szmulewitz RZ, Flaig TW, Tombal B, Morlock R, Ivanescu C, Ramaswamy K, Saad F, Armstrong AJ. Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. Eur Urol. 2020 Oct;78(4):603-614. doi: 10.1016/j.eururo.2020.03.019. Epub 2020 Apr 23.

    PubMed 32336645

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enzalutamide in people with Metastatic Hormone Sensitive Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 203 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 203 sites in United States, Japan, France, Russia, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria (time frame: From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02677896, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.

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