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)


Condition: Metastatic Hormone Sensitive Prostate Cancer

Intervention:

  • Drug: Enzalutamide
  • Drug: Placebo

Purpose: The purpose of this study is to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study will also evaluate the safety of enzalutamide plus ADT in mHSPC.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02677896

Sponsor: Astellas Pharma Global Development, Inc.

Primary Outcome Measures:

  • Measure: Radiographic progression-free survival (rPFS)
  • Time Frame: Up to 4 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: Up to 7 years
  • Safety Issue:
  • Measure: Time to first symptomatic skeletal event (SSE)
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Time to castration resistance
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Time to deterioration of quality of life (QoL)
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Time to initiation of a new antineoplastic therapy
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Time to PSA progression
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: PSA undetectable rate
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Objective response rate
  • Time Frame: Up to 4 years
  • Safety Issue:
  • Measure: Time to pain progression
  • Time Frame: Up to 4 years
  • Safety Issue:

Estimated Enrollment: 1100

Study Start Date: March 7, 2016

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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 or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan. 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.

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-α 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.
  • 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

Contact:

  • Astellas Pharma Global Development
  • 800-888-7704 Ext. 5473

Locations:

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  • Site JP81011
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  • Bucharest Romania
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  • Site RU70001
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  • Site RU70003
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  • Omsk Russian Federation
  • Site RU70005
  • Penza Russian Federation
  • Site RU70007
  • St. Petersburg Russian Federation
  • Site RU70008
  • St. Petersburg Russian Federation
  • Site RU70009
  • St. Petersburg Russian Federation
  • Site RU70012
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  • Site RU70016
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  • Site SK42110
  • Bratislava Slovakia
  • Site SK42109
  • Kosice Slovakia
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  • Nitra Slovakia
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  • Site ES34006
  • Pamplona Navarra Spain
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  • Site ES34007
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  • Madrid Spain
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  • Madrid Spain
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  • Örebro Orebro Län Sweden
  • Site SE46001
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  • Site SE46006
  • Stockholm Sodermanlands Lan Sweden
  • Site SE46004
  • Sundsvall Vasternorrlands Lan Sweden
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  • Goteborg Vastra Gotalands Lan Sweden
  • Site TW88601
  • Kaohsiung 112 Taiwan
  • Site TW88606
  • Taichung 40705 Taiwan
  • Site TW88602
  • Taipei Taiwan
  • Site TW88605
  • Taipei Taiwan
  • Site TW88607
  • Taoyuan 333 Taiwan
  • Site GB44002
  • Withington Manchester United Kingdom

View trial on ClinicalTrials.gov


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