WINGMEN

FULL TITLE

Windows trial of INsulin-like Growth factor neutralising antibody Xentuzumab in MEN scheduled for radical prostatectomy

Chief Investigator: Dr Simon Lord

Sponsor:  Oxford University

STUDY DESIGN

WINGMEN is a Phase 0 study of IGF antibody Xentuzumab in men with prostate cancer in the 3-4-week window prior to their scheduled radical prostatectomy.  The trial will test the feasibility of recruiting men with early prostate cancer, the tolerability of xentuzumab in the pre-operative setting, and will provide pre- and post- treatment samples for assessment of circulating and tissue markers of prostate cancer progression.  If effective at downregulating mediators of high IGF-1, this approach has potential to be tested for its ability to reduce the need for radical treatment in men with small cancers on active surveillance. The long-term aims are to prevent prostate cancer progression, identify biomarkers to predict who will benefit from IGF blockade, and identify key mediators that may be targets for risk reduction.

The total duration of participant involvement in the trial is approximately 12 weeks. Treatment duration is expected to be 3.5-4 weeks but patients may receive up to 10 treatments if standard of care surgery is delayed for any reason. The number of weeks of treatment has been extended up to 10 weeks from a maximum of 6 weeks initially, this is because there was some concern that surgery dates could be considerably delayed due to the COVID-19 pandemic. Patients will attend an end of study follow up visit 6 weeks after surgery which will coincide with the standard of care post-surgery assessment.  

STUDY POPULATION

The study population is Men with localised biopsy proven prostate adenocarcinoma, scheduled to be treated by radical prostatectomy.

STUDY SCHEMA

TARGET RECRUITMENT

Total 30 patients

PARTICIPATING SITES

Churchill Hospital – Oxford University Hospital NHS Trust

INCLUSION CRITERIA

1. Men with prostate adenocarcinoma confirmed on prostate biopsy and with sufficient cancer-containing biopsy tissue surplus to diagnostic need to provide ³2 sections for primary endpoint analysis.
2. Scheduled for open or robotic radical prostatectomy
3. Age ≥ 18 years
4. ECOG performance score of 0 or 1.
5. The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study
6. Patient is willing and able to give informed consent
7. Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and 70 days thereafter
8. Adequate haematologic, renal and hepatic function defined as follows:

*eGFR calculated by Cockcroft & Gault formula

EXCLUSION CRITERIA

1. Treated with corticosteroids, insulin, metformin, other oral hypoglycemic agent, or anti-androgens in the 28 days prior to first dose of study drug
2. Diabetes mellitus
3. Previous prostate radiotherapy
4. Current or previous treatment with xentuzumab or other IGF or GH -modifying therapy
5. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
6. Treatment with any other investigational agent, or treatment in another interventional clinical trial within 28 days prior to enrolment
7. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.

PRIMARY OBJECTIVE

Assess the amount of IGF pathway blockade induced by xentuzumab

Key dates

-          13Dec2021 Opened to recruitment

-          Expected study end date: 31Dec2022