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Metastatic Castration-Resistant Prostate CancerPhase 4NCT02116582

A Study to Evaluate Enzalutamide After Abiraterone in Metastatic Castration-Resistant Prostate Cancer

A Phase 4 study testing Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Astellas Pharma Europe B.V. at 50 sites in 5 countries.

Completed

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

Official record
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Trial summary

The 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
50 sitesin 5 countries
Study dates
23 May 2014to 29 Sep 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • Subject 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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).

Trial locations and contacts

50 sites in 5 countries.

50 sites in 5 countries

Germany15 sites

  • Site DE49015

    Bergisch Gladbach, Northwest, 51427

  • Site DE49014

    Berlin, 10247

  • Site DE49003

    Berlin, 12200

  • Site DE49009

    Bonn, 53111

  • Site DE49010

    Dresden, 01307

  • Site DE49017

    Duisburg, North Rhine-Westphalia, 47179

  • Site DE49016

    Düsseldorf, 40225

  • Site DE49004

    Göttingen, 37075

  • Site DE49001

    Hamburg, 22081

  • Site DE49008

    Hamburg, 22399

  • Site DE49007

    Hanover, 30625

  • Site DE49002

    Heidelberg, 69120

  • Site DE49012

    Münster, 48149

  • Site DE49005

    Nürtingen, Baden-Wurttemberg, 72622

  • Site DE49006

    Tübingen, 72076

Other trials in Germany

France13 sites

  • Site FR33015

    Angers, 49055

  • Site FR33009

    Caen, 14076

  • Site FR33010

    Créteil, 94010

  • Site FR33014

    Le Mans, 72015

  • Site FR33013

    Lyon, 69003

  • Site FR33003

    Marseille, 13273

  • Site FR33008

    Nantes Saint Herblain Cedex, 44805

  • Site FR33002

    Nîmes, 30029

  • Site FR33011

    Paris, 75005

  • Site FR33001

    Paris, 75908

  • Site FR33007

    Rennes, 35042

  • Site FR33005

    Suresnes, 92151

  • Site FR33012

    Villejiuf, 94805

Other trials in France

Spain9 sites

  • Site ES34009

    Badalona, 8916

  • Site ES34011

    Barcelona, 08003

  • Site ES34006

    Barcelona, 08025

  • Site ES34008

    Barcelona, 08035

  • Site ES34001

    Madrid, 28007

  • Site ES34003

    Madrid, 28034

  • Site ES34002

    Madrid, 28040

  • Site ES34010

    Madrid, 28044

  • Site ES34004

    Santiago de Compostela, A Coruna, 15706

Other trials in Spain

United Kingdom8 sites

  • Site GB44004

    Birmingham, B15 2TT

  • Site GB44009

    Brighton, BN2 5BE

  • Site GB44002

    Glasgow, G12 0YN

  • Site GB44007

    London, SE1 9RT

  • Site GB44003

    Northwood, Middlesex, HA6 2RN

  • Site GB44010

    Plymouth, PL6 8DH

  • Site GB44001

    Sutton, Surrey, SM2 5PT

  • Site GB44006

    Withington, M204BX

Other trials in United Kingdom

Belgium5 sites

  • Site BE32001

    Brussels, Flemish Brabant, 1200

  • Site BE32004

    Ghent, 9000

  • Site BE32007

    Hasselt, 3500

  • Site BE32003

    Kortrijk, 8500

  • Site BE32002

    Liège, 4000

Other trials in Belgium

About this study

Official title: A Multi-center, Single Arm Study of Enzalutamide in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate

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.

Being tested
Enzalutamide
Keywords
MDV3100, Xtandi, Abiraterone, Metastatic Castration-Resistant Prostate Cancer, Enzalutamide

What participants receive

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

  • EnzalutamideDrug

    Also called MDV3100, Xtandi

    Participants received 160 mg of enzalutamide (soft capsules) orally once daily.

Study groups in NCT02116582
Study groupRoleWhat they receive
EnzalutamideExperimentalParticipants 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.
Receives: Drug: Enzalutamide

What is being measured

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

  1. Radiographic Progression-free Survival (rPFS)

    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.

    Measured: 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)

  1. Overall Survival (OS)

    OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discontinued study drug. OS median was estimated using the KM method. A 2-sided 95% CI was provided for this estimate using the BC method.

    Measured: From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years.

  2. Percentage of Participants With a Prostate-specific Antigen (PSA) Response

    PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution.

    Measured: 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.

  3. Time to PSA Progression

    The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progression median. A 2-sided 95% CI was provided for this estimate using the BC method.

    Measured: 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.

  4. Number of Participants With Adverse Events (AEs)

    A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).

    Measured: 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.

Timeline

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

  1. First posted17 Apr 2014 (estimated)
  2. Study start23 May 2014
  3. Primary completion8 May 2016
  4. Study completion29 Sep 2017

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02116582
Sponsor's protocol ID
9785-CL-0410
Other IDs
2013-002271-17
Status last verified
Nov 2024
First submitted
15 Apr 2014
Last updated
6 Dec 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Publications

  • 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.

    PubMed 28844372

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enzalutamide in people with Metastatic Castration-Resistant Prostate Cancer, run by Astellas Pharma Europe B.V. at 50 sites in 5 countries.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Germany, France, Spain, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Radiographic Progression-free Survival (rPFS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02116582, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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