A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT) - Trial ANZCTR12623000160639

Timeline & Enrollment

Primary Outcome

Complete pathological response rate at prostatectomy following treatment with combination of EPI-7386 + Darolutamide, or Darolutamide alone for 12 weeks. Assessed on the pathological specimen obtained from prostatectomy.

Summary

The purpose of this study is to compare the efficacy of administering the drugs, EPI-7386 and Darolutamide, in combination versus Darolutamide alone, as treatment for patients with prostate cancer, before they undergo standard surgery to remove the prostate gland. Who is it for? You may be eligible for this study if you have been diagnosed with localized prostate cancer and have been referred for radical prostatectomy surgery. Study details Participants will be randomly allocated to either doublet therapy consisting of EPI-7386 and Darolutamide (Arm A) or Darolutamide alone (Arm B) for a treatment duration of 12 weeks. Treatment will be in the form of oral tablets. Prostatectomy will occur the day after completing neoadjuvant therapy, and specimens removed during surgery will then be examined to determine treatment efficacy. It is hoped that information collected in this study will help inform treatment options for patients with localized prostate cancer undergoing removal of their prostate.

ICD-10 Classifications