WINGMEN: IGF inhibition with xentuzumab prior to radical prostatectomy
Research type
Research Study
Full title
Windows trial of INsulin-like Growth factor neutralising antibody Xentuzumab in MEN scheduled for radical prostatectomy
IRAS ID
242236
Contact name
Simon Lord
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics & Assurance
Eudract number
2018-000204-42
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
Research Summary
The WINGMEN trial aims to understand how a hormone-like protein called insulin-like growth factor (IGF) helps prostate cancers grow and become aggressive. IGF is required for normal development, and also helps cancers grow and spread. Men with high blood IGF are at increased risk of developing prostate cancer, and tall men are more likely to get aggressive prostate cancer. The WINGMEN trial will recruit 30 men with prostate cancer who have been offered an operation to remove the prostate. Most men have to wait 4-5 weeks between a decision to have prostate removal surgery, and actually having the operation. In this 4-5 week window we will offer treatment with a new IGF-blocker drug called xentuzumab. The drug is provided by Boehringer Ingelheim and the trial is funded by Prostate Cancer UK. Xentuzumab will be given as an outpatient by once weekly intravenous infusion (drip) in the Early Phase Clinical Trials Unit, Oxford Cancer Centre, Churchill Hospital. In other trials, xentuzumab is being tested in patients with advanced cancer, and is proving to be well-tolerated. After the 4-week treatment, WINGMEN trial patients will have routine prostate removal surgery. Samples of blood and prostate cancer that are surplus to diagnostic need will be taken from the diagnostic prostate biopsy (pre-xentuzumab) and the cancer removed at surgery (after xentuzumab) for research tests. These samples will be compared to measure how effectively xentuzumab reduces signs of tumour growth, and identify which genes and proteins are switched on or off by xentuzumab, and which may therefore be important in helping IGF promote prostate cancer growth. The information we get from the WINGMEN trial may help us to improve treatment of men with prostate cancer, with the long-term aim of reducing the risk of aggressive prostate cancer
Summary of Results
The WINGMEN trial aims to understand how a protein similar to a hormone - insulin-like growth factor (IGF) - helps prostate cancers grow and become aggressive, making them more difficult to treat. IGF is required for normal development, but also helps cancers grow and spread. People with high levels of blood IGF are at increased risk of developing some cancers, including prostate cancer.
The WINGMEN trial recruited people with prostate cancer who had been offered an operation to remove the prostate. Most patients have to wait 4-5 weeks between a decision to have prostate removal surgery, and actually having the operation. In this window the WINGMEN patients were given treatment with an IGF-blocker drug called xentuzumab. Xentuzumab was given once weekly, by intravenous infusion (drip) in the Churchill Hospital, Oxford. Some patients had to wait a bit longer for their surgery and continued to receive weekly treatment throughout this time.
Samples of blood and tumour were taken both before patients received treatment with xentuzumab and after surgery. These samples were compared to measure how effectively xentuzumab reduces signs of tumour growth. They were also tested to identify which genes are switched on or off in cancer cells by xentuzumab, and which may therefore be important in understanding how IGF promotes prostate cancer growth.
27 patients took part in WINGMEN. 26 went on to have the operation to remove the prostate. The main analysis of the prostate samples showed significant reduction in IGF following treatment with xentuzumab. Furthermore, none of the patients had severe side effects to xentuzumab.Additional tests on the blood and prostate samples are ongoing. Information from these tests will help us to determine how to improve treatment of men with prostate cancer, with the long-term aim of reducing the risk of aggressive prostate cancer.
The WINGMEN study has provided, and will provide, a great deal of information regards the effects on cancer biology of targeting the insulin growth factor. This will help us understand how we might develop future drugs that target this hormone, including how we can select patients and combine with other cancer treatments.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0170
Date of REC Opinion
6 Jul 2021
REC opinion
Further Information Favourable Opinion