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A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01302041
First received: February 21, 2011
Last updated: July 12, 2017
Last verified: July 2017
  Purpose
To evaluate the effect of enzalutamide on prostate specific antigen (PSA) level in men with prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: Enzalutamide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label, Single-arm, Efficacy and Safety Study of Enzalutamide (MDV3100) in Patients With Hormone-naïve Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Percentage of Participants With a Prostate-specific Antigen (PSA) Response at Week 25 [ Time Frame: Baseline and Week 25 ]

    A PSA response was defined as a decline from Baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory.

    Participants with an unknown or missing response or who discontinued prior to Week 25 for any reason were treated as non-responders.



Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 30 days after last dose. Adverse events with an onset date occurring within 2 years (i.e., before or on Day 730), as of the cut-off date of 28 December 2013, are reported. ]

    Each adverse events (AE) was assessed by the investigator for causal relationship to the study drug; those deemed possibly or probably related to study drug are reported as drug regimen related AEs (DRRAEs).

    A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:

    • Resulted in death
    • Was life-threatening
    • Resulted in persistent or significant disability/incapacity
    • Resulted in congenital anomaly or birth defect
    • Required inpatient hospitalization or led to prolongation of hospitalization
    • Other medically important events.

  • Percent Change From Baseline in PSA [ Time Frame: Baseline and Weeks 25, 49 and 97 ]
  • Percent Change From Baseline in Sex Hormone-binding Globulin (SHBG) [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Androstenedione [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Dehydroepiandrosterone (DHEA) [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Dihydrotestosterone (DHT) [ Time Frame: Baseline and Week 25 and 49 ]
  • Percent Change From Baseline in Estradiol [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Follicle-stimulating Hormone (FSH) [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Luteinizing Hormone (LH) [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Prolactin [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Total Testosterone [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Percent Change From Baseline in Free Testosterone [ Time Frame: Baseline and Weeks 25 and 49 ]
  • Plasma Concentration of Enzalutamide at Pre-dose (Ctrough) [ Time Frame: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25 ]
  • Plasma Concentration of Enzalutamide Metabolite M2 at Pre-dose (Ctrough) [ Time Frame: Pre-dose at Weeks 2, 3, 4, 5, 9, 13, 21 and 25 ]
  • Percentage of Participants With a PSA Response at Weeks 49 and 97 [ Time Frame: Baseline and Weeks 49 and 97 ]
    A PSA response was defined as a decline from baseline in PSA level of 80% or greater. Blood samples for PSA were collected and analyzed at a central laboratory. Participants with an unknown or missing response or who discontinued prior to Week 49 or Week 97 for any reason were treated as non-responders.

  • Percentage of Participants With a 90% or Greater Reduction From Baseline in PSA Level [ Time Frame: Baseline and Weeks 25, 49 and 97 ]

    Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.

    Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders.


  • Percentage of Participants With PSA ≤ 4 ng/ml [ Time Frame: Weeks 25, 49 and 97 ]

    Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.

    Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders.


  • Percentage of Participants With PSA ≤ 0.1 ng/ml [ Time Frame: Weeks 25, 49 and 97 ]

    Participants with unknown or missing PSA results at Week 25 or who discontinued prior to Week 25 were considered non-responders at Week 25.

    Participants with unknown or missing PSA results at Week 49 or Week 97 were considered non-responders.


  • Maximum Decline From Baseline in PSA [ Time Frame: Baseline to Week 25 and from Baseline up to the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929) ]
    The maximum decline from Baseline in PSA was calculated as the largest reduction from Baseline in PSA level that occurred at any point after treatment start up to Week 25 and up to and including the assessment made at the safety follow-up visit, divided by the PSA Baseline value and multiplied by 100, i.e., the maximum percent change from baseline.

  • Time to PSA Response [ Time Frame: From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days) ]
    Time to PSA response (PSA decline ≥ 80% from Baseline) is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 80% or greater was recorded. Time to response was estimated using the Kaplan-Meier method.

  • Time to PSA Decline ≥ 90% [ Time Frame: From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days) ]
    Time to PSA decline ≥ 90% is defined as the time interval from the first study drug dose to the first date a decline from Baseline in PSA level of 90% or greater was recorded. Time to PSA decline ≥ 90% was estimated using the Kaplan-Meier method.

  • Time to PSA ≤ 4 ng/ml [ Time Frame: From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days). ]
    Time to PSA ≤ 4 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 4 ng/ml or below was recorded. Time to PSA ≤ 4 ng/ml was estimated using the Kaplan-Meier method.

  • Time to PSA ≤ 0.1 ng/ml [ Time Frame: From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days). ]

    Time to PSA ≤ 0.1 ng/ml is defined as the time interval from the first study drug dose to the first date a decline in PSA to a result of 0.1 ng/ml or below was recorded.

    Time to PSA ≤ 0.1 ng/ml was estimated using the Kaplan-Meier method.


  • Time to PSA Progression [ Time Frame: From first dose until the data cut-off date of 28 December 2013; median duration of treatment was 754.0 days (range of 52-929 days). ]
    Time to PSA progression is defined as the time interval from the first study drug dose to the first date of PSA progression. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir unless the PSA next measurement(s), if available, does not confirm the PSA progression.

  • PSA Doubling Time [ Time Frame: From Baseline to Week 25 ]
    PSA doubling time was to be calculated from the slope estimated from a linear regression of the natural log of PSA fitted on time, if the slope was positive. Since the slope was negative for all participants, PSA doubling time could not be calculated.


Enrollment: 67
Actual Study Start Date: May 6, 2011
Study Completion Date: April 27, 2017
Primary Completion Date: July 29, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
Drug: Enzalutamide
Oral
Other Names:
  • Xtandi
  • MDV3100

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
  • Asymptomatic from prostate cancer
  • Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
  • PSA ≥ 2 ng/mL at screening

Exclusion Criteria:

Has previously or is currently receiving:

  • Hormonal therapy with intent to treat prostate cancer
  • Systemic glucocorticoids
  • Chemotherapy with the intent to treat prostate cancer
  • Opiate analgesics for pain from prostate cancer
  • Radiation therapy for treatment of the primary tumor or metastases
  • Has history of known or suspected brain or skull metastases or leptomeningeal disease
  • Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
  • Clinically significant cardiovascular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302041

Locations
Belgium
Site BE1003
Brussels, Belgium, 1090
Site BE1001
Brussels, Belgium, 1200
Site BE1002
Kortrijk, Belgium, 8500
Site BE1005
Leuven, Belgium, 3000
Czechia
Site CZ3006
Olomouc, Czechia, 77520
Site CZ3002
Praha 6, Czechia, 16000
Denmark
Site DK4001
Aarhus N, Denmark, 8200
Site DK4004
Copenhagen, Denmark, DK-2100
Site DK4002
Herlev, Denmark, 2730
Germany
Site DE5005
Aachen, Germany, 51074
Site DE5007
Bonn, Germany, 53111
Site DE5003
Hannover, Germany, 30625
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Trump D. Commentary on: "Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study." Tombal B, Borre M, Rathenborg P, Werbrouck P, Van Poppel H, Heidenreich A, Iversen P, Braeckman J, Heracek J, Baskin-Bey E, Ouatas T, Perabo F, Phung D, Hirmand M, Smith MR. Institut de Recherche Clinique, Université Catholique de Louvain, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be. Aarhus University Hospital, Aarhus, Denmark. Herlev Hospital, Herlev, Denmark. AZ Groeninge Kortrijk, Kortrijk, Belgium. UZ Leuven, Leuven, Belgium. Klinik und Poliklinik für Urologie, RWTH University Aachen, Aachen, Germany. Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. UZ Brussel, Brussels, Belgium. Univerzita Karlova v Praze, Prague, Czech Republic. Astellas Pharma Global Development, Leiden, Netherlands. Astellas Pharma Global Development, Northbrook, IL, USA. Medivation Inc, San Francisco, CA, USA. Massachusetts General Hospital Cancer Center, Boston, MA, USA: Lancet Oncol. 2014 May;15(6):592-600; doi: 10.1016/S1470-2045(14)70129-9. [Epub 2014 Apr 14]. Urol Oncol. 2016 May;34(5):248-9. doi: 10.1016/j.urolonc.2015.03.012. Epub 2015 Apr 30.

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01302041     History of Changes
Other Study ID Numbers: 9785-CL-0321
2010-021287-16 ( EudraCT Number )
Study First Received: February 21, 2011
Results First Received: February 16, 2016
Last Updated: July 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
bone turnover
hormone-naïve
prostate specific antigen
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017