Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Millennium Pharmaceuticals, Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Voluntary written consent
Screening PSA ≥ 2ng/ml
Patients must have a diagnosis of mCRPC
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Prior surgical or medical castration with testosterone at screening \< 50 ng/dL
You may not be if
Prior chemotherapy for prostate cancer within 6 months prior to screening. (Any prior therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.)
Documented central nervous system metastases
Clinically significant heart disease
Patients who have an abnormal 12-lead ECG result at screening including one or more of the following: QRS\>110 ms, QTcF\>480ms, PR interval\>200 ms
Patients who have a history of risk factors for TdP including unexplained syncope, known long QT syndrome, heart failure, angina, or clinically significant abnormal laboratory assessments
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
Clareo Health | Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
