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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02677896
Ethics application status
Date submitted
5/02/2016
Date registered
9/02/2016

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 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.

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.

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.


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
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
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)
Timepoint [1] 0 0
From date of randomization to OS final analysis (28 May 2021); Maximum treatment duration was 58.6 months
Secondary outcome [2] 0 0
Time to Prostate Specific Antigen (PSA) Progression
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
Timepoint [3] 0 0
From date of randomization to data cut-off date (28 May 2021); Maximum treatment duration was 58.6 months
Secondary outcome [4] 0 0
PSA Undetectable Rate
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)
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
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)
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
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)
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)
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2024
Sample size
Target
Accrual to date
Final
1150
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
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
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
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United States of America
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Alabama
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United States of America
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Alaska
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Ohio
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Tennessee
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Texas
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Washington
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Lyon Cedex 3
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Nimes
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Pierre Benite
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Quimper
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Saint Mande
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Bonn
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Hamburg
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Heidelberg
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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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Jerusalem
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Russian Federation
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Russian Federation
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Russian Federation
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Penza
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Russian Federation
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St. Petersburg
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Michalovce
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Slovakia
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Nitra
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Slovakia
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Poprad
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Slovakia
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Trencin
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Slovakia
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Žilina
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Spain
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A Coruña
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Cataluña
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Spain
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Comunidad Valenciana
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Spain
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Navarra
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Spain
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Avila
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Spain
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Madrid
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Sweden
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Orebro Län
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Sweden
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Skåne Län
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Sweden
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Sodermanlands Lan
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Sweden
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Vasternorrlands Lan
Country [141] 0 0
Sweden
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeie... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02677896