PRESIDE (9785-MA-1001)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated with Docetaxel plus Prednisolone Who Have Progressed on Enzalutamide Alone
IRAS ID
161138
Contact name
Simon Chowdhury
Contact email
Sponsor organisation
ICON plc
Eudract number
2013-004711-50
Duration of Study in the UK
3 years, 1 months, 16 days
Research summary
Research Summary -
This is a prostate cancer trial involving adult men with metastatic castrate resistant prostate cancer (mCRPC) who have failed androgen-deprivation therapy (ADT) but who are naïve to chemotherapy. The purpose of the study is to evaluate whether continued treatment with enzalutamide, a novel androgen receptor inhibitor, in combination with docetaxel chemotherapy offers clinical benefit over switching to treatment with docetaxel chemotherapy alone. This Study will be conducted in oncology centres within Hospital sites. Subjects will be involved in the Study for up to approximately 3 years depending on disease progression. In order to evaluate disease progression and to monitor safety the subjects will undergo the following assessments: PSA, bone scans, CT and/or MRI imaging, ECGs, blood tests, quality of life questionnaires.
Lay Summary of Results -
In this study, enzalutamide was given to men with prostate cancer. Firstly, all the men were given enzalutamide. Then, the men whose cancer became worse received chemotherapy, together with either enzalutamide or a placebo. In this study, the placebo looked like enzalutamide but didn’t have any medicine in it. On average, it took longer for the cancer to come back in the men who were given enzalutamide with chemotherapy (9.53 months) compared to the men who were given the placebo with chemotherapy (8.28 months).
REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/1739
Date of REC Opinion
24 Nov 2014
REC opinion
Further Information Favourable Opinion