Metastatic Hormone Sensitive Prostate Cancer (mHSPC) MedDRA version: 19.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: XTANDI
Product Name: Enzalutamide
Product Code: MDV3100
Pharmaceutical Form: Tablet
INN or Proposed INN: ENZALUTAMIDE
CAS Number: 915087-33-1
Current Sponsor code: MDV3100
Concentration un
Sponsors
Astellas Pharma Global Development, Inc (APGD)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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 CT or 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 at screening. - Subject has an estimated life expectancy of = 12 months as assessed by the Investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 550
Exclusion criteria
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 luteinizing hormone-releasing hormone (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 9 months before randomization as neoadjuvant/adjuvant therapy. - Subject received treatment with 5-a 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 androgen receptor or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central review;Secondary Objective: To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as - assessed by overall survival (OS) - assessed by time to first Symptomatic Skeletal Event (SSE) - assessed by time to castration resistance - assessed by Quality of Life (QoL) (as measured by Quality of Life Prostate-specific Questionnaire [QLQ-PR25] / Functional Assessment of Cancer Therapy-Prostate [FACT-P] and EuroQol Group-5 Dimension-5 Level Instrument [EQ-5D-5L]) - assessed by time to start of new antineoplastic therapy - assessed by time to prostate-specific antigen (PSA) progression - assessed by PSA undetectable rate (< 0.2 ng/mL) - assessed by objective response rate (ORR) - assessed by worsening of pain (as measured by Brief Pain Inventory-Short Form [BPI-SF]);Primary end point(s): rPFS: Defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review or death (defined as death from any cause within 24 weeks from study drug discontinuation), whichever occurs first.;Timepoint(s) of evaluation of this end point: ITT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - OS - Time to first SSE - Time to castration resistance - Time to deterioration of QoL - Time to initiation of new antineoplastic therapy - Time to PSA progression (= 2 ng/mL) (Prostate Cancer Clinical Trials Working Group 2 criteria) - PSA undetectable rate (< 0.2 ng/mL) - ORR - Time to pain progression;Timepoint(s) of evaluation of this end point: ITT | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Chile, China, Denmark, Finland, France, Germany, Israel, Italy, Japan, Korea, Republic of, Lithuania, Netherlands, New Zealand, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactService Desk - Global Clinical Dev.
Astellas Pharma Europe B.V.
Outcome results
None listed