Phase 3 efficacy&safety study of ODM-201 in high risk non-met CRPC
Research type
Research Study
Full title
A Multinational, Randomised, Double-Blind, Placebo-Controlled,Phase III Efficacy And Safety Study Of ODM-201 In Men With High-Risk Non-Metastatic Castration-Resistant Prostate Cancer
IRAS ID
161891
Contact name
Alison Birtle
Contact email
Sponsor organisation
Bayer Healthcare AG
Eudract number
2013-003820-36
Clinicaltrials.gov Identifier
114769, IND Number
Duration of Study in the UK
5 years, 7 months, 7 days
Research summary
Research Summary
There is no standard treatment for Castrate Resistant Prostate Cancer (CRPC) patients who have rising PSA during Androgen Deprived Therapy (ADT) and no detectable metastases (nmCRPC). These patients may be given a number of different hormone treatments which have not been proven to improve either how long they may live or when their cancer may come back.
This study aims to see if ODM-210 can achieve either of these two aims.This is a randomised Phase III multicentre study in which 1500 patients will be recruited. 2 of every 3 patients will receive the new drug and 1 of every 3 placebo. These patients with nmCRPC are at high risk of their cancer returning.
The study aims to assess whether the new treatment ODM-201 is effective for men with nmCRPC and what side effects they may experience.
This will be monitored with CT and bone scans at regular intervals and standard Quality of life assessment tools together with routine blood tests.
Patients will carry on with their allocated treatment until it is deemed to be ineffective at which stage they will stop their allocated treatment
The maximum period of follow up is 6 years and most of these patients would be in the oncology clinic already.Summary of Results
The main questions the researchers wanted to answer in this trial were firstly, did it take longer for the cancer to spread in the participants who took darolutamide? The answer was yes. It took about 40.4 months for the cancer to spread in the participants who took darolutamide. Whereas It took about 18.4 months for the cancer to spread in the participants who took the placebo. Secondly, what medical problems happened during the trial? The researchers kept track of the medical problems that the doctors thought might be related to the treatments. These are known as “adverse reactions”. In this trial, some of the participants had adverse reactions, and a few of them were serious. The most common adverse reaction was tiredness.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/1258
Date of REC Opinion
29 Oct 2014
REC opinion
Further Information Favourable Opinion