A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

NCT02288247

Last updated date
Study Location
Site AT43004
Linz, , 4010, Austria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Castration Resistant Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;

- Ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of investigational medicinal product (IMP), or bilateral orchiectomy (i.e., surgical or medical castration);

- Metastatic disease documented by at least 2 bone lesions on bone scan, or soft tissue disease documented by computed tomography (CT)/magnetic resonance imaging (MRI);

- Progressive disease at study entry defined as the following occurring in the setting of castrate levels of testosterone: Prostate specific antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination.

- Asymptomatic or minimally symptomatic prostate cancer (Brief Pain Inventory - Short Form (BPI-SF) question 3 score of < 4);

- Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;

- Estimated life expectancy of ≥ 12 months;

- Be suitable and willing to receive chemotherapy as part of the trial;

- Able to swallow the IMP and comply with study requirements;

- Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment with the following agents for the treatment of prostate cancer:
Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a
clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory
therapies; Cytotoxic chemotherapy; Participation in a clinical trial of an
investigational agent that inhibits the AR or androgen synthesis unless the treatment
was placebo;


- Current or prior treatment within 4 weeks prior to initiation of IMP with the
following agents for the treatment of prostate cancer: Antiandrogens; 5-α reductase
inhibitors; Estrogens; Anabolic steroids; Drugs with antiandrogenic properties;
Progestational agents;


- Subject has received investigational therapy within 28 days or 5 half-lives whichever
is longer, prior to initiation of IMP;


- Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to
initiation of IMP;


- Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation
of IMP;


- Major surgery within 4 weeks prior to initiation of IMP;


- History of seizure or any condition that may predispose to seizures at any time in the
past. History of loss of consciousness or transient ischemic attack within 12 months
prior to Screening;


- Known or suspected brain metastasis or active leptomeningeal disease;


- History of another malignancy within the previous 5 years other than non-melanoma skin
cancer;


- Clinically significant cardiovascular disease;


- Gastrointestinal disorders affecting absorption;


- Medical contraindications to the use of prednisolone or docetaxel;


- Allergies to any of the active ingredients or excipients in the study drugs

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Metastatic Castration Resistant Prostate CancerA Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone
NCT02288247
  1. Linz,
  2. Vienna,
  3. Bonheiden,
  4. Liege,
  5. Ottignies,
  6. Brno,
  7. Olomouc,
  8. Plzeň -Lochotín,
  9. Praha 2,
  10. Albi,
  11. Montpellier,
  12. Nîmes,
  13. Paris,
  14. Paris,
  15. Plerin,
  16. Quimper,
  17. Reims,
  18. Suresnes,
  19. Nürtingen, Baden-Württemberg
  20. Aachen,
  21. Bergisch Gladbach,
  22. Hannover,
  23. Heidelberg,
  24. Mannheim,
  25. Munster,
  26. Tübingen,
  27. Ulm,
  28. Wuppertal,
  29. Heraklion, Crete
  30. Heraklion, Crete
  31. Athens,
  32. Athens,
  33. Thessaloniki,
  34. Arezzo,
  35. Brescia,
  36. Milano,
  37. Naples,
  38. Pavia,
  39. Roma,
  40. Rome,
  41. Terni,
  42. Amsterdam,
  43. Blaricum,
  44. Hoofddorp,
  45. Nieuwegein,
  46. Rotterdam,
  47. Drammen,
  48. Kristiansand,
  49. Stavanger,
  50. Gdańsk,
  51. Krakow,
  52. Lodz,
  53. Warszawa,
  54. Warszawa,
  55. Obninsk, Kaluga
  56. Moscow,
  57. Moscow,
  58. Moscow,
  59. St. Petersburg,
  60. St. Petersburg,
  61. Lugo,
  62. Madrid,
  63. Madrid,
  64. Madrid,
  65. Madrid,
  66. Malaga,
  67. Murcia,
  68. Santander,
  69. Sevilla,
  70. Valencia,
  71. Göteborg,
  72. Kalmar,
  73. Solna,
  74. Uppsala,
  75. Locarno, Tessin
  76. Zurich,
  77. Ankara,
  78. Istanbul,
  79. Izmir,
  80. Aberdeen,
  81. Cambridge,
  82. Cardiff,
  83. Exeter,
  84. London,
  85. Northwood,
  86. Norwich,
  87. Nottingham,
  88. Swansea,
  89. Wirral,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone
Official Title  ICMJE A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated With Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone
Brief Summary The purpose of the study is to understand if there is benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer has gotten worse when treated with enzalutamide alone.
Detailed Description

The study will be conducted in consecutive periods of open label treatment with enzalutamide followed by randomized double-blind treatment with continued enzalutamide or placebo, in combination with docetaxel and prednisolone.

Open Label (Period 1)

Participants will receive open label treatment with enzalutamide. At week 13, all participants will be assessed by prostate-specific antigen (PSA) and imaging. Participants with no confirmed PSA response or evidence of radiographic progression will be ineligible for participation in Period 2 and will typically have safety follow up; however, Period 1 treatment may continue for some participants as long as the investigator considers it to be of clinical benefit (stopping on initiation of any new antineoplastic therapy). Participants with confirmed PSA response will continue Period 1 until disease progression.

Enrollment to Period 2 will cease after approximately 274 participants have been enrolled or 182 primary endpoint events have been reached, whichever occurs first. Participants who are not randomized into period 2 at this time may continue receiving open label treatment in an extension period.

Randomization (Double Blind) (Period 2)

Participants with confirmed disease progression on enzalutamide alone who continue to meet all eligibility criteria may proceed to randomization. Treatment allocation will be in a 1:1 ratio, stratified by disease progression in Period 1 to the following treatments:

  • Enzalutamide with docetaxel and prednisolone
  • Placebo with docetaxel and prednisolone

Any ongoing participants in Period 2 at the point of unblinding in the enzalutamide+docetaxel arm that are still receiving and benefitting from enzalutamide treatment , will have the option to continue treatment via an extension period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castration Resistant Prostate Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    Oral
    Other Names:
    • Xtandi
    • ASP9785
  • Drug: Docetaxel
    intravenous infusion
  • Drug: Prednisolone
    Oral
  • Drug: Placebo
    Oral
Study Arms  ICMJE
  • Experimental: Enzalutamide with docetaxel + prednisolone
    Continued treatment with enzalutamide after adding docetaxel and prednisolone
    Interventions:
    • Drug: Enzalutamide
    • Drug: Docetaxel
    • Drug: Prednisolone
  • Placebo Comparator: Placebo with docetaxel + prednisolone
    Treatment with placebo after adding docetaxel and prednisolone
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisolone
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 15, 2017)
690
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2014)
650
Estimated Study Completion Date  ICMJE September 2021
Actual Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
  • Ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of initiation of investigational medicinal product (IMP), or bilateral orchiectomy (i.e., surgical or medical castration);
  • Metastatic disease documented by at least 2 bone lesions on bone scan, or soft tissue disease documented by computed tomography (CT)/magnetic resonance imaging (MRI);
  • Progressive disease at study entry defined as the following occurring in the setting of castrate levels of testosterone: Prostate specific antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ? 1 week between each determination.
  • Asymptomatic or minimally symptomatic prostate cancer (Brief Pain Inventory - Short Form (BPI-SF) question 3 score of < 4);
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1;
  • Estimated life expectancy of ? 12 months;
  • Be suitable and willing to receive chemotherapy as part of the trial;
  • Able to swallow the IMP and comply with study requirements;
  • Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

  • Prior treatment with the following agents for the treatment of prostate cancer: Aminoglutethimide; Ketoconazole; Abiraterone; Enzalutamide or participation in a clinical trial of enzalutamide; 223Ra, 89Sr, 153Sm, 186Re/188Re; Immunomodulatory therapies; Cytotoxic chemotherapy; Participation in a clinical trial of an investigational agent that inhibits the AR or androgen synthesis unless the treatment was placebo;
  • Current or prior treatment within 4 weeks prior to initiation of IMP with the following agents for the treatment of prostate cancer: Antiandrogens; 5-? reductase inhibitors; Estrogens; Anabolic steroids; Drugs with antiandrogenic properties; Progestational agents;
  • Subject has received investigational therapy within 28 days or 5 half-lives whichever is longer, prior to initiation of IMP;
  • Use of opiate analgesia for pain from prostate cancer within 4 weeks prior to initiation of IMP;
  • Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to initiation of IMP;
  • Major surgery within 4 weeks prior to initiation of IMP;
  • History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months prior to Screening;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another malignancy within the previous 5 years other than non-melanoma skin cancer;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorders affecting absorption;
  • Medical contraindications to the use of prednisolone or docetaxel;
  • Allergies to any of the active ingredients or excipients in the study drugs
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czechia,   France,   Germany,   Greece,   Italy,   Netherlands,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02288247
Other Study ID Numbers  ICMJE 9785-MA-1001
2013-004711-50 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Clinical Study Report (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.
URL:https://www.clinicalstudydatarequest.com
Responsible Party Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
Study Sponsor  ICMJE Astellas Pharma Europe Ltd.
Collaborators  ICMJE Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Medical DirectorAstellas Pharma Europe Ltd.
PRS Account Astellas Pharma Inc
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP