CHROME
Research type
Research Study
Full title
Phase II study of the use of neoadjuvant cabazitaxel with hormonal treatment in patients with high risk operable prostate cancer, to assess the efficacy and toxicity of cabazitaxel, and, to explore potential predictive and prognostic markers of clinical outcome.
IRAS ID
238004
Contact name
Helen Scott
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Eudract number
2014-000841-55
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is a study where patients with high risk prostate cancer will be given an extra medication before they have their operation to remove the prostate cancer. We want to look at whether this drug may be successful as a treatment for prostate cancer. We will be looking at men who have high risk prostate cancer, and who are eligible for surgery (radical prostatectomy).
Two thirds of the patients who take part in CHROME will be given the study drug Cabazitaxel for 4 cycles (alongside 3 months of hormonal treatment) before they have their surgery. One third of the patients will have immediate surgery, and will not receive Cabazitaxel and hormonal treatment. During the study, and for 3 years after surgery, patients will have a blood test which tests the levels of a protein which is higher in men with prostate cancer. This will help determine whether Cabazitaxel may be able to be used as a treatment for prostate cancer.
REC name
HSC REC B
REC reference
20/NI/0003
Date of REC Opinion
21 Jan 2020
REC opinion
Favourable Opinion