CaNCaP02 - CAmbridge Neoadjuvant CAncer of the Prostate Study 2
Research type
Research Study
Full title
A study into the pharmacodynamic biomarker effects of AZD2014 (an mTOR1/2 inhibitor) given prior to Radical Prostatectomy
IRAS ID
149326
Contact name
Simon Pacey
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eudract number
2014-000214-56
Clinicaltrials.gov Identifier
Research summary
In the UK prostate cancer is the 4th most common cause of cancer death. At diagnosis around 15% of men with prostate cancer are found to have high risk disease and are significantly more likely to suffer treatment failure from radical therapy, disease progression and mortality. Standard treatment for localised prostate cancer is prostate gland removal surgery (radical prostatectomy) or radiation therapy. Giving neoadjuvant treatment (prior to surgery) may help delay or prevent relapse in men with high risk prostate cancer.
There is a large body of information supporting a role for mTOR in prostate cancer. The mTOR signalling protein helps cancer cells to grow and multiply while controlling their energy use. Blocking the function of mTOR with AZD2014 (a selective mTOR1/2 inhibitor developed by AstraZeneca) may shut down the energy supply to prostate cancer cells leading to reduced cell growth and slowing disease progression. AZD2014 is being tested for patients with cancer in early clinical trials and drugs with a similar mechanism of action to AZD2014 are already licensed for use in patients with cancer and other diseases.
This study will investigate the intra-tumoural action(s) of AZD2014 given to patients with prostate cancer prior to radical prostatectomy. The primary outcome measure is the degree of mTOR1/2 signalling inhibition in prostate tumour samples following AZD2014 treatment. Secondary objectives include establishing the incidence and severity of adverse events from AZD2014 and determining plasma concentration and pharmacokinetics of AZD2014. Exploratory endpoints include the measurement of biological effects caused by AZD2014 treatment and biomarker validation.
Twenty men with high risk early prostate cancer suitable for radical prostatectomy will be recruited over a period of 18 months. Patients will be treated with 50 mg AZD2014 twice daily for two weeks before surgery and will be closely monitored to ensure their safety.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/0179
Date of REC Opinion
4 Jul 2014
REC opinion
Further Information Favourable Opinion