Two clinical trials have had their study protocols amended, announces Pfizer and Astellas Pharma. The Phase 3 trials, called ‘Arches’ and ‘Embark’, will investigate the safety and effectiveness of the drug Xtandi® (enzalutamide) as a potential treatment for hormone-sensitive prostate cancer. For additional details, you can read the source press release here, at Pfizer’s website.
About Prostate Cancer
Prostate cancer is one of the most common forms of cancer in men worldwide. The prostate is a small gland found in men. Usually, prostate cancer develops slowly and people who are affected may not have noticeable symptoms for a long time. However, according to the NHS, some patients may experience a frequent need to or straining when urinating, and feeling as though their bladder hasn’t completely emptied.
About the ‘Arches’ Study
The Arches stud is a Phase 3 clinical trial comparing treatment with Xtandi (enzalutamide) and androgen deprivation therapy, to androgen deprivation therapy alone in men who have metastatic hormone-sensitive prostate cancer. Recent changes to this study include changes to the planned analyses of both the primary and endpoint (radiographic progression-free survival), and the secondary endpoints of the study. The trial was originally expected to be completed in April 2020, but, according to the recent announcement, this date has changed to late 2018.
About the ‘Embark’ Study
The Embark study is also a Phase 3 clinical trial designed to investigate the effects of enzalutamide in patients with high-risk metastatic hormone-sensitive prostate cancer. This study has already completed enrolment, and patients will be given enzalutamide and leuprolide, enzalutamide monotherapy, or leuprolide by itself.
Changes to the study protocol affect the planned analyses of the primary endpoint (metastasis-free survival), and multiple secondary endpoints. As a result, the clinical trial is expected to end in mid-2020, rather than the originally planned date of March 2021.
For more information, you can view details of the two clinical trials at ClinicalTrials.gov using the reference code NCT02677896 for the Arches study, and NCT02319837 for the Embark study.