Risk of Seizure Among Subjects with mCRPC
Research type
Research Study
Full title
A Multicenter, Single-Arm, Open-Label, Post-Marketing Safety Study to Evaluate the Risk of Seizure Among Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated with Enzalutamide Who Are at Potential Increased Risk of Seizure
IRAS ID
140101
Contact name
Johann De Bono
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2013-003022-92
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to examine the frequency of experiencing seizures and monitor the safety of the study medication (Enzalutamide) in patients with metastatic castration-resistant prostate cancer or other medical conditions or other factors which are known to have or which have the potential to increase seizure risk.
This is a worldwide study and approximately 400 patients across 100 centres are expected to participate.
The participants will remain in the study for approximately 4 months and are expected to attend the following study visits
- Screening visit (up to 4 weeks prior to treatment initiation) to have their
eligibility assessed- Treatment period (4 month) – after the participant have signed consent and
completed the screening visit he will be enrolled onto the study to start
receiving study medication. The study medication (Enzalutamide) comes in the
form of soft gelatin capsules and taken orally once daily. The participant will
visit the hospital 3 times during this period (Week 1, Week 5 and Week 13).- Follow-up visit – 4 weeks following the last dose or before the participant may
start on new anticancer treatment. During this period the participant will
attend the hospital in order to have safety tests performed- Extension period - After 4 months (at Week 17), if the participant is benefiting
from the treatment he will be allowed to continue on the study medication, until
the study doctor feels the participant is no longer benefiting from the study
medication or decides to start a new treatment for the participant.During the study the participant will undergo a number of tests such as: blood sampling, measurement of vital signs, physical examination, neurological examination and completion of a seizure event questionnaire.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/0314
Date of REC Opinion
16 Jun 2014
REC opinion
Further Information Favourable Opinion