A study to investigate efficacy and safety of Enzalutamide in patients with hormone-naïve prostate cancer
- Conditions
- Hormone-naïve prostate cancerMedDRA version: 18.1Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-021287-16-BE
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 60
1.Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures.
2.Male aged 18 years or older.
3.Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy (ADT) is indicated (except when indicated in a neoadjuvant/adjuvant therapy).
4.Asymptomatic from prostate cancer.
5.Non-castrate level of testosterone (= 8 nmol/L (230 ng/dL)) at screening.
6.PSA = 2 ng/mL at screening.
7.Eastern Cooperative Oncology Group (ECOG) score of 0
8.A life expectancy of at least 12 months.
9.Is able to swallow the study drug and comply with the study requirements.
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 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56
1.Has had previous or is currently receiving hormonal therapy with intent to treat prostate cancer (surgical castration or other hormonal manipulation, e.g., GnRH agonists, GnRH antagonists, antiandrogens, estrogens, 5 alpha reductase inhibitors).
2.Has received systemic glucocorticoids within 6 months prior to enrollment or is expected to require systemic glucocorticoids during the study period.
3.Prior chemotherapy with the intent to treat prostate cancer.
4.Known or suspected brain or skull metastases or leptomeningal disease.
5.Use of opiate analgesics for pain from prostate cancer.
6.Has a known or suspected hypersensitivity to MDV3100 or any components of the formulation used.
7.Has concurrent disease or any clinically significant abnormality following the investigator’s review of the pre-study physical examination, ECG and clinical laboratory tests, which in the judgment of the investigator would interfere with the subject's participation in this study or evaluation of study results.
8.History of hypogonadism.
9.History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer.
10.Radiation therapy for treatment of the primary tumor within 3 months prior to enrollment.
11.Radiation therapy for the treatment of metastases.
12.Major surgery within 2 months prior to enrollment.
13.History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with anti-epileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to treatment (day 1 visit).
14.Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) within 4 weeks of enrollment.
15.Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease).
16.Clinically significant cardiovascular disease including any of the following:
•Myocardial infarction within 6 months prior to screening
•Uncontrolled angina within 3 months prior to screening
•Congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is = 45%
•History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
•History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
•Uncontrolled hypertension as indicated by a resting systolic blood pressure >170 mm Hg or diastolic blood pressure >105 mm Hg at the screening visit.
17.Absolute neutrophil count < 1,500/µL, platelet count < 100,000/µL, and hemoglobin < 5.6 mmol/L (9 g/dL) at screening; (NOTE: subjects must not have received any growth factors or blood transfusions within 7 days of the hematologic laboratory values obtained at screening).
18.Total bilirubin > 1.5 times the upper limit of normal (ULN) at screening. This will not apply to subjects with Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of MDV3100 on prostate-specific antigen (PSA);Secondary Objective: To evaluate the safety and tolerability of MDV3100 in subjects who have not previously received hormone treatment for prostate cancer.<br>To evaluate the pharmacodynamic (PD) effects of MDV3100 on circulating testosterone (T), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), androstenedione, dehydroepiandrosterone (DHEA), luteinizing hormone (LH), follicule stimulating hormone (FSH), estradiol and prolactin.<br>To evaluate the pharmacokinetics (PK) of MDV3100 and its major metabolite M2.;Primary end point(s): PSA response, defined as a decline in PSA level of 80% or greater at week 25.;Timepoint(s) of evaluation of this end point: At week 25 treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety, pharmacodynamic and pharmacokinetic assessments;Timepoint(s) of evaluation of this end point: At week 25 treatment