Protocol 9785-CL-0335
Research type
Research Study
Full title
A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC).
IRAS ID
202718
Contact name
Ananya Choudhury
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc (APGD)
Eudract number
2015-003869-28
Duration of Study in the UK
4 years, 0 months, days
Research summary
Prostate cancers are initially dependent on the hormone testosterone for growth, and therapies that lower or block the ability of testosterone to act on prostate cancer can be effective treatments. However over time, many prostate cancers progress in spite of these treatments.
Enzalutamide is used to treat prostate cancers that no longer respond to treatments that lower testosterone. In this study, enzalutamide will be studied to treat prostate cancer that has spread to other parts of the body and still responds to treatments that lower or block male sex hormone activities.The aim of this study is to test whether enzalutamide when added to a treatment that lowers testosterone will delay the progress of prostate cancer and to see how safe enzalutamide is for the treatment of Metastatic Hormone Sensitive Prostate Cancer (mHSPC). The study is double-blind and placebo-controlled.
In previous clinical studies, over 5000 patients with prostate cancer, over 400 women with breast cancer and over 300 male subjects with no known cancer (including healthy men and subjects with liver impairment) have received at least 1 dose of enzalutamide in completed and ongoing studies as of February 2016. In two large clinical studies, 1671 prostate cancer patients were treated with enzalutamide at a dose of 160mg once daily and at this dose, it was found to be generally well-tolerated.Approximately 1100 subjects will participate, recruited from up to 29 countries. Each subject will be in the study for approximately 2 years, depending on the disease response, then will be followed up every 12 weeks until the end of their lives.
During the study, there will be 13 study visits to the research centre. Procedures involved include physical examinations, 12-lead ECGs, blood tests, urine tests, CT/MRI and bone scans, chest x-ray or chest CT and questionnaires.
This study is sponsored by Astellas.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0602
Date of REC Opinion
21 Oct 2016
REC opinion
Further Information Favourable Opinion