Bicalutamide with or without deforolimus in prostate cancer
Research type
Research Study
Full title
A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus in Men With Asymptomatic, Metastatic Castrate-Resistant Prostate Cancer
IRAS ID
6343
Contact name
Johann de Bono
Sponsor organisation
Merck & Co
Eudract number
2008-000422-39
Clinicaltrials.gov Identifier
Research summary
Prostate cancer is successfully treated with surgery or drugs that act against male hormones. However, if a patient relapses, current guidelines recommend that a second form of treatment, called anti-androgens, is started as soon as a 'marker' of disease progression called prostate-specific antigen, or PSA, begins to rise. A new drug called ridaforolimus may slow the progress of the disease further if added to anti-androgen therapy.All patients will receive an anti-androgen called bicalutamide. Half the study patients will also receive ridaforolimus. Study treatment will continue until there is evidence of disease progression. Every four weeks, patients will be assessed for PSA and their tumours will be measured using x-rays every 12 weeks.Study patients will continue to be seen after they have discontinued treatment because of disease progression. These visits will be every four weeks and x-ray assessment every 12 weeks.
REC name
London - Hampstead Research Ethics Committee
REC reference
08/H0720/148
Date of REC Opinion
29 Dec 2008
REC opinion
Further Information Favourable Opinion