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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02677896




Registration number
NCT02677896
Ethics application status
Date submitted
5/02/2016
Date registered
9/02/2016
Date last updated
4/05/2021

Titles & IDs
Public title
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Scientific 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)
Secondary ID [1] 0 0
2015-003869-28
Secondary ID [2] 0 0
9785-CL-0335
Universal Trial Number (UTN)
Trial acronym
ARCHES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Hormone Sensitive Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Placebo

Experimental: Enzalutamide + Androgen Deprivation Therapy (ADT) - Participants received enzalutamide orally once daily. 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.

Placebo Comparator: Placebo + Androgen Deprivation Therapy (ADT) - Participants received matching placebo orally once daily. 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.


Treatment: Drugs: Enzalutamide
Oral

Treatment: Drugs: Placebo
Oral

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 78 months
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Up to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Up to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [7] 0 0
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 prior to the data analysis cut-off date. 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 by the time of the data cut-off point, time to SSE was censored on the last visit date or the date of randomization, whichever occurred last.
Timepoint [7] 0 0
From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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-a 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Site AU61016 - Camperdown
Recruitment hospital [2] 0 0
Site AU61007 - St Leonards
Recruitment hospital [3] 0 0
Site AU61006 - Sydney
Recruitment hospital [4] 0 0
Site AU61009 - Tweed Heads
Recruitment hospital [5] 0 0
Site AU61013 - Waratah
Recruitment hospital [6] 0 0
Site AU61001 - Woodville South
Recruitment hospital [7] 0 0
Site AU61004 - Ballarat
Recruitment hospital [8] 0 0
Site AU61015 - Clayton
Recruitment hospital [9] 0 0
Site AU61017 - Parkville
Recruitment hospital [10] 0 0
Site AU61008 - St. Albans
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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2065 - St Leonards
Recruitment postcode(s) [3] 0 0
- Sydney
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2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
5011 - Woodville South
Recruitment postcode(s) [7] 0 0
- Ballarat
Recruitment postcode(s) [8] 0 0
- Clayton
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment postcode(s) [10] 0 0
- St. Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Alaska
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Indiana
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Kansas
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Virginia
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Washington
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Buenos Aires
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Hovestaden
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Herlev
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Odense C
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Oulun Laani
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Oulu
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La Roche sur Yon
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Lille Cedex
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Nimes
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Pierre Benite
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France
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Quimper
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Saint Mande
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Germany
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Baden-Württemberg
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Germany
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Bonn
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Germany
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Hamburg
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Germany
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Heidelberg
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Israel
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HaMerkaz
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Italy
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Trentino-Alto Adige
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Italy
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Veneto
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Gunma
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Kagawa
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Japan
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Kanagawa
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Miyagi
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Yamaguchi
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Japan
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Fukuoka
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Japan
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Kyoto
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Japan
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Nagasaki
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Japan
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Niigata
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Yamagata
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Korea, Republic of
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Gyeonggi-do
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Netherlands
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Friesland
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Gelderland
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Noord-Brabant
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Netherlands
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Noord-Holland
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Overijssel
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Zuid-Holland
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New Zealand
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Bay Of Plenty
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New Zealand
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Northland
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New Zealand
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South Island
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New Zealand
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Tasman District
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New Zealand
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Hamilton
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Poland
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Dolnoslaskie
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Malopolskie
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Mazowieckie
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Pomerania
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Pomorskie
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Myslowice
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Romania
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Cluj
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Timis
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Romania
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Brasov
Country [116] 0 0
Romania
State/province [116] 0 0
Bucharest
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Ivanovo
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Moscow
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Omsk
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Penza
Country [121] 0 0
Russian Federation
State/province [121] 0 0
St. Petersburg
Country [122] 0 0
Slovakia
State/province [122] 0 0
Bratislava
Country [123] 0 0
Slovakia
State/province [123] 0 0
Kosice
Country [124] 0 0
Slovakia
State/province [124] 0 0
Michalovce
Country [125] 0 0
Slovakia
State/province [125] 0 0
Nitra
Country [126] 0 0
Slovakia
State/province [126] 0 0
Poprad
Country [127] 0 0
Slovakia
State/province [127] 0 0
Trencin
Country [128] 0 0
Slovakia
State/province [128] 0 0
Žilina
Country [129] 0 0
Spain
State/province [129] 0 0
A Coruña
Country [130] 0 0
Spain
State/province [130] 0 0
Asturias
Country [131] 0 0
Spain
State/province [131] 0 0
Barcelona
Country [132] 0 0
Spain
State/province [132] 0 0
Cataluña
Country [133] 0 0
Spain
State/province [133] 0 0
Comunidad Valenciana
Country [134] 0 0
Spain
State/province [134] 0 0
Navarra
Country [135] 0 0
Spain
State/province [135] 0 0
Avila
Country [136] 0 0
Spain
State/province [136] 0 0
Madrid
Country [137] 0 0
Sweden
State/province [137] 0 0
Orebro Län
Country [138] 0 0
Sweden
State/province [138] 0 0
Skåne Län
Country [139] 0 0
Sweden
State/province [139] 0 0
Sodermanlands Lan
Country [140] 0 0
Sweden
State/province [140] 0 0
Vasternorrlands Lan
Country [141] 0 0
Sweden
State/province [141] 0 0
Vastra Gotalands Lan
Country [142] 0 0
Taiwan
State/province [142] 0 0
Kaohsiung
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taichung
Country [144] 0 0
Taiwan
State/province [144] 0 0
Taipei
Country [145] 0 0
Taiwan
State/province [145] 0 0
Taoyuan
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Global Development, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02677896
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications