A Multinational, Randomized, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naive Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0000302
- Lead Sponsor
- ovotech Asia Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 1680
1. Age 18 or older and willing and able to provide informed consent;
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
3. Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e., surgical or medical castration);
4. Patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
5. Serum testosterone level = 1.73 nmol/L (50 ng/dL) at the Screening visit;
6. Patients receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks;
7. Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy as defined in eligibility criterion #3:
- PSA progression defined by a minimum of two rising PSA levels with an interval of = 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (= 4 weeks since last flutamide or = 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be = 2 µg/L (2 ng/mL);
- Soft tissue disease progression defined by RECIST 1.1;
- Bone disease progression defined by PCWG2 with two or more new lesions on bone scan;
8. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT/MRI. Patients whose disease spread is limited to regional pelvic lymph nodes are not eligible;
9. No prior cytotoxic chemotherapy for prostate cancer;
10. Asymptomatic or mildly symptomatic from prostate cancer (i.e., the score on the Brief Pain Inventory - Short Form (APPENDIX C) Question #3 must be < 4);
11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
12. Estimated life expectancy of = 6 months;
13. Able to swallow the study drug and comply with study requirements.
1.Severe concurrent disease,infection,or co-morbidity that,in the judgment of the Investigator,would make the patient inappropriate for enrollment
2.Known or suspected brain metastasis or active leptomeningeal disease,or visceral metastatic disease in patients who are candidates for initiation of cytotoxic chemotherapy
3.History of another malignancy within the previous 5years other than curatively treated non melanomatous skin cancer
4.Absolute neutrophil count<1,500/µL,or platelet count<100,000/µL,or hemoglobin<5.6 mmol/L(9g/dL)at the Screening visit.(NOTE:patients may not have received any growth factors within7days or blood transfusions within 28days of the hematologic laboratory values obtained at the Screening visit)
5.Total bilirubin,alanine aminotransferase(ALT)or aspartate aminotransferase(AST)>2.5times the upper limit of normal at the Screening visit
6.Creatinine>177µmol/L(2mg/dL)at the Screening visit
7.Albumin<30g/L(3.0g/dL)at the Screening visit
8.History of seizure or any condition that may predispose to seizure.Also,history of loss of consciousness or transient ischemic attack within12months of enrollment (Day1visit)
9.Clinically significant cardiovascular disease including:
- Myocardial infarction within 6months
- Uncontrolled angina within 3months
- Congestive heart failure New York Heart Association(NYHA)class3or4,or patients with history of congestive heart failure NYHA class3or4 in the past,unless a screening echocardiogram or multi-gated acquisition scan performed within 3months 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
- Hypotension as indicated by systolic blood pressure<86millimeters of mercury(mmHg) at the Screening visit
- Bradycardia as indicated by a heart rate of<50beats per minute on the Screening ECG
- Uncontrolled hypertension as indicated by systolic blood pressure>170mmHg or diastolic blood pressure>105mmHg at the Screening visit
10.Gastrointestinal disorder affecting absorption(e.g.gastrectomy,active peptic ulcer disease within last3months)
11.Major surgery within4weeks of enrollment(Day1Visit)
12.Use of opiate analgesics for pain from prostate cancer within4weeks of enrollment(Day1visit)
13.Radiation therapy for treatment of the primary tumor within3weeks of enrollment (Day1visit)
14.Radiation or radionuclide therapy for treatment of metastasis
15.Treatment with flutamide within 4 weeks of enrollment(Day1visit)
16.Treatment with bicalutamide or nilutamide within6weeks of enrollment(Day1visit)
17.Treatment with5-a reductase inhibitors(finasteride,dutasteride),estrogens,cyproterone within4weeks of enrollment(Day1visit)
18.Treatment with systemic biologic therapy for prostate cancer(other than approved bone targeted agents and GnRH-analogue therapy)or other agents with anti-tumor activity within4weeks of enrollment(Day1visit)
19.History of prostate cancer progression on ketoconazole
20.Prior use,or participation in a clinical trial,of an investigational agent that blocks androgen synthesis(e.g.abiraterone acetate,TAK-700,TAK-683,TAK-448)or blocks the androgen receptor(e.g.BMS641988)
21.Participation in a previous clinical trial ofMDV3100
22.Use of an investigational agent within 4weeks of enrollment(Day1visit)
23.Use of herbal products that may have hor
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival;Progression-Free Survival
- Secondary Outcome Measures
Name Time Method Time to First Skeletal-Related Event;Time to Initiation of Cytotoxic Chemotherapy;Time to PSA Progression;Functional Assessment of Cancer Therapy-Prostate;European Quality of Life 5-Domain Scale;Brief Pain Inventory