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

October 22, 2025 updated by: Astellas Pharma Global Development, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1180AAX
        • Site AR54010
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Site AR54002
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Site AR54007
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Site AU61016
      • St Leonards, New South Wales, Australia, 2065
        • Site AU61007
      • Sydney, New South Wales, Australia
        • Site AU61006
      • Tweed Heads, New South Wales, Australia, 2485
        • Site AU61009
      • Waratah, New South Wales, Australia, 2298
        • Site AU61013
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Site AU61001
    • Victoria
      • Ballarat, Victoria, Australia
        • Site AU61004
      • Clayton, Victoria, Australia
        • Site AU61015
      • Parkville, Victoria, Australia
        • Site AU61017
      • St Albans, Victoria, Australia
        • Site AU61008
  • Belgium
      • Liège, Belgium
        • Site BE32008
      • Yvoir, Belgium
        • Site BE32007
    • Hainaut
      • Mons, Hainaut, Belgium
        • Site BE32001
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium
        • Site BE32012
    • West-Vlaanderen
      • Kortrijk, West-Vlaanderen, Belgium
        • Site BE32005
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Site CA15016
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N6
        • Site CA15024
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Site CA15003
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Site CA15022
    • Ontario
      • Brampton, Ontario, Canada, L6T 4S5
        • Site CA15010
      • Kingston, Ontario, Canada, K7L 2V7
        • Site CA15021
      • Oakville, Ontario, Canada, L6H 3P1
        • Site CA15013
      • Toronto, Ontario, Canada, M5G 2M9
        • Site CA15020
    • Quebec
      • Granby, Quebec, Canada, J2G 8Z9
        • Site CA15023
      • Montreal, Quebec, Canada, H3T1E2
        • Site CA15004
  • Chile
      • Santiago, Chile
        • Site CL56003
    • RM
      • Santiago, RM, Chile
        • Site CL56001
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile
        • Site CL56005
    • Región de la Araucanía
      • Temuco, Región de la Araucanía, Chile
        • Site CL56002
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile
        • Site CL56007
    • Viña Del Mar
      • Reñaca, Viña Del Mar, Chile
        • Site CL56004
  • Denmark
      • Herlev, Denmark
        • Site DK45003
      • Odense C, Denmark
        • Site DK45001
    • Central Jutland
      • Aarhus, Central Jutland, Denmark
        • Site DK45005
      • Holstebro, Central Jutland, Denmark
        • Site DK45008
    • Hovestaden
      • Copenhagen, Hovestaden, Denmark
        • Site DK45002
    • North Denmark
      • Aalborg, North Denmark, Denmark
        • Site DK45004
  • Finland
      • Jakobstad, Finland
        • Site FI35806
      • Oulu, Finland
        • Site FI35805
      • Turku, Finland
        • Site FI35807
    • Etelä-Suomen Lääni
      • Helsinki, Etelä-Suomen Lääni, Finland
        • Site FI35802
    • Länsi-Suomen Lääni
      • Pori, Länsi-Suomen Lääni, Finland
        • Site FI35804
      • Seinäjoki, Länsi-Suomen Lääni, Finland
        • Site FI35803
    • Oulun Laani
      • Tampere, Oulun Laani, Finland
        • Site FI35801
  • France
      • Bordeaux, France
        • Site FR33006
      • Caen, France, 14076
        • Site FR33014
      • La Roche-sur-Yon, France
        • Site FR33005
      • Le Mans, France
        • Site FR33015
      • Lille, France
        • Site FR33012
      • Lyon, France
        • Site FR33007
      • Nîmes, France
        • Site FR33011
      • Pierre-Bénite, France
        • Site FR33001
      • Quimper, France
        • Site FR33009
      • Saint-Mandé, France
        • Site FR33013
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France
        • Site FR33010
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Site FR33003
  • Germany
      • Bonn, Germany, 53111
        • Site DE49005
      • Hamburg, Germany, 20246
        • Site DE49014
      • Heidelberg, Germany, 69120
        • Site DE49013
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany
        • Site DE49002
      • Nürtingen, Baden-Wurttemberg, Germany
        • Site DE49004
  • Israel
      • Beersheba, Israel
        • Site IL97210
      • Haifa, Israel
        • Site IL97202
      • Haifa, Israel
        • Site IL97205
      • Jerusalem, Israel
        • Site IL97206
    • Central District
      • Kfar Saba, Central District, Israel
        • Site IL97201
      • Ẕerifin, Central District, Israel
        • Site IL97211
  • Italy
      • Candiolo, Italy, 10060
        • Site IT39009
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy
        • Site IT39005
    • Lombardy
      • Cremona, Lombardy, Italy
        • Site IT39004
      • Milan, Lombardy, Italy
        • Site IT39003
      • Milan, Lombardy, Italy
        • Site IT39012
    • Piedmont
      • Novara, Piedmont, Italy
        • Site IT39007
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Italy, 38100
        • Site IT39011
    • Tuscany
      • Pisa, Tuscany, Italy
        • Site IT39008
    • Veneto
      • Padua, Veneto, Italy
        • Site IT39006
  • Japan
      • Chiba, Japan
        • Site JP81002
      • Fukuoka, Japan
        • Site JP81014
      • Fukuoka, Japan
        • Site JP81015
      • Kyoto, Japan
        • Site JP81008
      • Nagasaki, Japan
        • Site JP81018
      • Niigata, Japan
        • Site JP81020
      • Yamagata, Japan
        • Site JP81019
    • Chiba
      • Sakura, Chiba, Japan
        • Site JP81003
    • Gunma
      • Maebashi, Gunma, Japan
        • Site JP81001
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan
        • Site JP81013
    • Kanagawa
      • Yokohama, Kanagawa, Japan
        • Site JP81007
    • Miyagi
      • Sendai, Miyagi, Japan
        • Site JP81016
    • Osaka
      • Abeno-ku, Osaka, Japan
        • Site JP81010
      • Chuo-ku, Osaka, Japan
        • Site JP81011
      • Sayama, Osaka, Japan
        • Site JP81012
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Site JP81006
      • Koto-ku, Tokyo, Japan
        • Site JP81004
      • Shinjuku-ku, Tokyo, Japan
        • Site JP81005
    • Yamaguchi
      • Ube, Yamaguchi, Japan
        • Site JP81017
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Site NL31003
      • Nijmegen, Gelderland, Netherlands
        • Site NL31007
    • North Brabant
      • Eindhoven, North Brabant, Netherlands
        • Site NL31005
    • North Holland
      • Alkmaar, North Holland, Netherlands
        • Site NL31010
      • Amsterdam, North Holland, Netherlands
        • Site NL31008
    • Overijssel
      • Zwolle, Overijssel, Netherlands
        • Site NL31009
    • Provincie Friesland
      • Sneek, Provincie Friesland, Netherlands
        • Site NL31002
    • South Holland
      • Rotterdam, South Holland, Netherlands
        • Site NL31006
  • New Zealand
      • Hamilton, New Zealand
        • Site NZ64004
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand
        • Site NZ64003
    • Northland
      • Kensington, Northland, New Zealand
        • Site NZ64008
    • South Island
      • Dunedin, South Island, New Zealand
        • Site NZ64002
    • Tasman District
      • Nelson, Tasman District, New Zealand
        • Site NZ64005
  • Poland
      • Mysłowice, Poland
        • Site PL48001
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland
        • Site PL48007
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland
        • Site PL48003
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland
        • Site PL48011
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland
        • Site PL48005
      • Słupsk, Pomeranian Voivodeship, Poland
        • Site PL48010
  • Romania
      • Brasov, Romania
        • Site RO40007
      • Bucharest, Romania
        • Site RO40003
      • Bucharest, Romania
        • Site RO40006
    • Cluj
      • Cluj-Napoca, Cluj, Romania
        • Site RO40008
      • Cluj-Napoca, Cluj, Romania
        • Site RO40009
      • Floreşti, Cluj, Romania
        • Site RO40002
    • Timiș County
      • Timișoara, Timiș County, Romania
        • Site RO40011
  • Russia
      • Ivanovo, Russia
        • Site RU70013
      • Moscow, Russia
        • Site RU70001
      • Moscow, Russia
        • Site RU70003
      • Moscow, Russia
        • Site RU70014
      • Omsk, Russia
        • Site RU70006
      • Penza, Russia
        • Site RU70005
      • Saint Petersburg, Russia
        • Site RU70007
      • Saint Petersburg, Russia
        • Site RU70008
      • Saint Petersburg, Russia
        • Site RU70009
      • Saint Petersburg, Russia
        • Site RU70012
      • Saint Petersburg, Russia
        • Site RU70016
  • Slovakia
      • Bratislava, Slovakia
        • Site SK42110
      • Košice, Slovakia
        • Site SK42109
      • Michalovce, Slovakia
        • Site SK42102
      • Nitra, Slovakia
        • Site SK42103
      • Poprad, Slovakia
        • Site SK42101
      • Trenčín, Slovakia
        • Site SK42107
      • Žilina, Slovakia, 012 07
        • Site SK42106
  • South Korea
      • Busan, South Korea
        • Site KR82007
      • Incheon, South Korea
        • Site KR82004
      • Seoul, South Korea
        • Site KR82001
      • Seoul, South Korea
        • Site KR82003
      • Seoul, South Korea
        • Site KR82002
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea
        • Site KR82008
  • Spain
      • Barcelona, Spain
        • Site ES34007
      • Madrid, Spain
        • Site ES34004
      • Madrid, Spain
        • Site ES34019
      • Ávila, Spain
        • Site ES34001
    • A Coruña
      • Salamanca, A Coruña, Spain
        • Site ES34011
    • Barcelona
      • Sabadell, Barcelona, Spain
        • Site ES34010
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Site ES34012
      • Barcelona, Catalonia, Spain
        • Site ES34014
    • Navarre
      • Pamplona, Navarre, Spain
        • Site ES34006
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain
        • Site ES34020
    • Valencia
      • Valencia, Valencia, Spain
        • Site ES34013
  • Sweden
    • Orebro Län
      • Örebro, Orebro Län, Sweden
        • Site SE46002
    • Skåne County
      • Malmo, Skåne County, Sweden
        • Site SE46001
    • Södermanland County
      • Stockholm, Södermanland County, Sweden
        • Site SE46006
    • Västernorrland County
      • Sundsvall, Västernorrland County, Sweden
        • Site SE46004
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden
        • Site SE46007
  • Taiwan
      • Kaohsiung City, Taiwan, 112
        • Site TW88601
      • Taichung, Taiwan, 40705
        • Site TW88606
      • Taipei, Taiwan
        • Site TW88605
      • Taoyuan District, Taiwan, 333
        • Site TW88607
  • United Kingdom
    • Manchester
      • Withington, Manchester, United Kingdom
        • Site GB44002
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Site US10016
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Site US10007
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Site US10008
    • California
      • Fountain Valley, California, United States, 92708
        • Site US10034
      • La Jolla, California, United States, 92093
        • Site US10056
      • Santa Rosa, California, United States, 95403
        • Site US10026
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site US10035
      • Denver, Colorado, United States, 80220
        • Site US10050
    • Florida
      • St. Petersburg, Florida, United States, 33710
        • Site US10048
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • Site US10054
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Site US10015
      • Springfield, Illinois, United States, 62703
        • Site US10043
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Site US10045
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Site US10020
    • Kansas
      • Kansas City, Kansas, United States, 66160-7233
        • Site US10055
    • Maryland
      • Towson, Maryland, United States, 21204
        • Site US10017
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Site US10036
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Site US10018
    • New York
      • Newburgh, New York, United States, 12550
        • Site US10025
      • Syracuse, New York, United States, 13210
        • Site US10029
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Site US10068
      • Concord, North Carolina, United States, 28025
        • Site US10009
      • Durham, North Carolina, United States, 27710
        • Site US10014
      • Greenville, North Carolina, United States, 27834
        • Site US10060
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Site US10044
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Site US10011
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Site US10012
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Site US10059
    • Texas
      • Dallas, Texas, United States, 75231
        • Site US10046
      • Dallas, Texas, United States, 75390-9110
        • Site US10004
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Site US10040
    • Washington
      • Burien, Washington, United States, 98166
        • Site US10002
      • Seattle, Washington, United States, 98101
        • Site US10013
      • Wenatchee, Washington, United States, 98801
        • Site US10028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enzalutamide + Androgen Deprivation Therapy (ADT)
Participants 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.
Drug: Enzalutamide
Oral
Other Names:
  • Xtandi
Placebo Comparator: Placebo + Androgen Deprivation Therapy (ADT)
Participants 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.
Drug: Placebo
Oral
Experimental: Placebo followed by Enzalutamide
Eligible 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.
Drug: Enzalutamide
Oral
Other Names:
  • Xtandi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)
rPFS Based on ICR of Bone Scan According to Protocol Assessment 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)
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.
From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization to death due to any cause (maximum duration was 58.6 months)
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.
From randomization to death due to any cause (maximum duration was 58.6 months)
Time to Prostate Specific Antigen (PSA) Progression
Time Frame: From the date of randomization to the first observation of PSA progression (maximum duration was 26.6 months)
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).
From the date of randomization to the first observation of PSA progression (maximum duration was 26.6 months)
Time to Start of New Antineoplastic Therapy
Time Frame: From randomization to the date of the first dose administration of the first antineoplastic therapy (maximum duration was 58.6 months)
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.
From randomization to the date of the first dose administration of the first antineoplastic therapy (maximum duration was 58.6 months)
PSA Undetectable Rate
Time Frame: From baseline to detectable PSA values (maximum duration was 26.6 months)
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.
From baseline to detectable PSA values (maximum duration was 26.6 months)
Objective Response Rate (ORR)
Time Frame: From date of randomization up to 26.6 months
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.
From date of randomization up to 26.6 months
Time to Deterioration in Urinary Symptoms
Time Frame: From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)
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.
From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)
Time to First Symptomatic Skeletal Event (SSE)
Time Frame: From randomization to the occurrence of the first SSE (maximum duration was 26.6 months)
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.
From randomization to the occurrence of the first SSE (maximum duration was 26.6 months)
Time to Castration Resistance
Time Frame: From randomization to the first castration-resistant event (maximum duration was 26.6 months)
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.
From randomization to the first castration-resistant event (maximum duration was 26.6 months)
Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time Frame: 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)
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.
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)
Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)
Time Frame: From randomization to the first pain progression event (maximum duration was 26.6 months)
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.
From randomization to the first pain progression event (maximum duration was 26.6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Global Development, Inc.

Collaborators

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Investigators

  • Study Director: Medical Director, Astellas Pharma Global Development, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2016

Primary Completion (Actual)

October 14, 2018

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimated)

February 9, 2016

Study Record Updates

Last Update Posted (Estimated)

October 24, 2025

Last Update Submitted That Met QC Criteria

October 22, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9785-CL-0335
  • 2015-003869-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Hormone Sensitive Prostate Cancer

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe