SAKK08/11
Research type
Research Study
Full title
Orteronel maintenance therapy in patients with metastatic castration resistant prostate cancer and non-progressive disease after first-line docetaxel therapy: A multicenter randomized double-blind placebo-controlled phase III trial.
IRAS ID
116824
Contact name
Simon Crabb
Sponsor organisation
University Hospital Southampton NHH trust
Eudract number
2011-002965-39
Clinicaltrials.gov Identifier
Research summary
Patients with advanced incurable prostate cancer which has become resistant to initial hormonal therapies are frequently treated with docetaxel chemotherapy. At the point of completion of chemotherapy, which takes up to 30 weeks, patients are currently monitored closely. Further treatment is only implemented at the point when their cancer progresses (which is unfortunately inevitable). Unfortunately progression at this stage commonly coincides with significant morbidity and disease related symptoms which can lower quality of life. In this clinical trial we propose to test a potential new approach to the treatment of advanced prostate cancer. We will investigate using maintenance therapy at the point that the disease has been stabilised by chemotherapy using a hormonal treatment that is usually exceptionally well tolerated (rather than simply waiting until progression occurs). We hope to determine if this will delay the time until progression of the disease following chemotherapy, when a patient is relatively well with good quality of life. This study is a trial of a drug called orteronel, a new hormonal treatment, compared to an inactive 'placebo'. There is a 50:50 chance of receiving the new medicine and patients and the clinical team will not know which tablet is being received (blinded). The trial is being carried out in England and Switzerland and will be recruiting 192 men in total over 2 years. Patients will be followed up as per standard NHS care, but in addition will have trial assessments such as blood tests, 3 monthly CT scans and bone scans. This trial will look at whether orteronel improves the length of time from the end of chemotherapy until the disease progresses (Event Free Survival) as well as other outcomes such as quality of life. Orteronel is usually very well tolerated. Common side effects can include tiredness, nausea and vomiting, constipation and headache.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
13/NE/0013
Date of REC Opinion
31 Jan 2013
REC opinion
Further Information Favourable Opinion