A Study to Evaluate Enzalutamide After Abiraterone in Metastatic Castration-Resistant Prostate Cancer
A Multi-center, Single Arm Study of Enzalutamide in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate
2 other identifiers
interventional
215
5 countries
50
Brief Summary
The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2014
Typical duration for phase_4
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedStudy Start
First participant enrolled
May 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 8, 2016
CompletedResults Posted
Study results publicly available
June 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2017
CompletedDecember 6, 2024
November 1, 2024
2 years
April 15, 2014
April 7, 2017
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic Progression-free Survival (rPFS)
Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer \& Crowley (BC) method.
From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.
Secondary Outcomes (4)
Overall Survival (OS)
From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years.
Percentage of Participants With a Prostate-specific Antigen (PSA) Response
From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months.
Time to PSA Progression
From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.
Number of Participants With Adverse Events (AEs)
From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.
Study Arms (1)
Enzalutamide
EXPERIMENTALParticipants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
Interventions
Participants received 160 mg of enzalutamide (soft capsules) orally once daily.
Eligibility Criteria
You may qualify if:
- Subject has histologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentiation or small cell features.
- Subject has metastatic disease documented by bone scan or by soft tissue disease observed by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) at screening, or within ≤30 days prior to Day 1.
- In the setting of castrate levels of testosterone ≤1.7 nmol/L (or ≤50 ng/dL), subject has progressive disease at study entry defined as PSA rise determined by a minimum of 2 rising PSA levels with an interval of ≥ 1 week between each assessment. The PSA value at the screening visit should be ≥ 2 ng/mL WITH or WITHOUT:
- Soft tissue disease progression defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) at screening, or within ≤30 days prior to Day 1. Measurable disease is not required for entry. Lymph nodes ≥ 2 cm are considered measurable disease (Prostate Cancer Clinical Trials Working Group (PCWG2)).
- Bone disease progression defined by at least 2 new lesions on bone scan at screening, or within ≤30 days prior to Day 1.
- Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate within its approved label indication and has discontinued use at least 4 weeks prior to start of study drug at Day 1.
- If the subject has received previous treatment with chemotherapy for prostate cancer, this must be limited to no more than one prior line of docetaxel, and must have been used prior to abiraterone acetate therapy.
- Subject receives and will continue to receive ongoing androgen deprivation with Luteinizing-hormone-releasing hormone (LHRH) analogue therapy throughout the course of the study or has had a bilateral orchiectomy.
- Subject is asymptomatic or mildly symptomatic from prostate cancer:
- The score on Brief Pain Inventory - Short Form (BPI-SF) Question #3 must be \< 4.
- No use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to screening.
You may not qualify if:
- Subject has prior use of ketoconazole for the treatment of prostate cancer.
- Subject has prior use of cabazitaxel.
- Subject has prior use of enzalutamide.
- Subject has received ANY anti-neoplastic therapy (including antiandrogens and chemotherapy) following abiraterone acetate discontinuation and prior to start of study drug at Day 1.
- Subject has a known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
- Subject has known or suspected brain metastases or active leptomeningeal disease.
- Subject has history of seizure or any condition that may predispose to seizure (e.g., prior stroke or significant brain trauma).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Site BE32001
Brussels, Flemish Brabant, 1200, Belgium
Site BE32004
Ghent, 9000, Belgium
Site BE32007
Hasselt, 3500, Belgium
Site BE32003
Kortrijk, 8500, Belgium
Site BE32002
Liège, 4000, Belgium
Site FR33015
Angers, 49055, France
Site FR33009
Caen, 14076, France
Site FR33010
Créteil, 94010, France
Site FR33014
Le Mans, 72015, France
Site FR33013
Lyon, 69003, France
Site FR33003
Marseille, 13273, France
Site FR33008
Nantes Saint Herblain Cedex, 44805, France
Site FR33002
Nîmes, 30029, France
Site FR33011
Paris, 75005, France
Site FR33001
Paris, 75908, France
Site FR33007
Rennes, 35042, France
Site FR33005
Suresnes, 92151, France
Site FR33012
Villejiuf, 94805, France
Site DE49005
Nürtingen, Baden-Wurttemberg, 72622, Germany
Site DE49017
Duisburg, North Rhine-Westphalia, 47179, Germany
Site DE49015
Bergisch Gladbach, Northwest, 51427, Germany
Site DE49014
Berlin, 10247, Germany
Site DE49003
Berlin, 12200, Germany
Site DE49009
Bonn, 53111, Germany
Site DE49010
Dresden, 01307, Germany
Site DE49016
Düsseldorf, 40225, Germany
Site DE49004
Göttingen, 37075, Germany
Site DE49001
Hamburg, 22081, Germany
Site DE49008
Hamburg, 22399, Germany
Site DE49007
Hanover, 30625, Germany
Site DE49002
Heidelberg, 69120, Germany
Site DE49012
Münster, 48149, Germany
Site DE49006
Tübingen, 72076, Germany
Site ES34004
Santiago de Compostela, A Coruna, 15706, Spain
Site ES34009
Badalona, 8916, Spain
Site ES34011
Barcelona, 08003, Spain
Site ES34006
Barcelona, 08025, Spain
Site ES34008
Barcelona, 08035, Spain
Site ES34001
Madrid, 28007, Spain
Site ES34003
Madrid, 28034, Spain
Site ES34002
Madrid, 28040, Spain
Site ES34010
Madrid, 28044, Spain
Site GB44001
Sutton, Surrey, SM2 5PT, United Kingdom
Site GB44004
Birmingham, B15 2TT, United Kingdom
Site GB44009
Brighton, BN2 5BE, United Kingdom
Site GB44002
Glasgow, G12 0YN, United Kingdom
Site GB44007
London, SE1 9RT, United Kingdom
Site GB44003
Northwood, Middlesex, HA6 2RN, United Kingdom
Site GB44010
Plymouth, PL6 8DH, United Kingdom
Site GB44006
Withington, M204BX, United Kingdom
Related Publications (1)
de Bono JS, Chowdhury S, Feyerabend S, Elliott T, Grande E, Melhem-Bertrandt A, Baron B, Hirmand M, Werbrouck P, Fizazi K. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for >/=24 weeks in Europe. Eur Urol. 2018 Jul;74(1):37-45. doi: 10.1016/j.eururo.2017.07.035. Epub 2017 Aug 23.
PMID: 28844372DERIVED
Related Links
MeSH Terms
Interventions
Limitations and Caveats
For participants on treatment after the primary analysis data cut-off point (08 May 2016), only AEs were assessed every 24 weeks until treatment discontinuation or death, this was not required for those that enrolled into 9785-CL-0123 (NCT02960022).
Results Point of Contact
- Title
- Executive Medical Director
- Organization
- Astellas Pharma Europe B.V.
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 17, 2014
Study Start
May 23, 2014
Primary Completion
May 8, 2016
Study Completion
September 29, 2017
Last Updated
December 6, 2024
Results First Posted
June 8, 2017
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/.