Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) - Trial NCT06401980

Timeline & Enrollment

Primary Outcome

Radiographic progression-free survival (rPFS)

Summary

Despite improvements in treatment, metastatic prostate cancer remains incurable, especially
 in the case of pretreated metastatic castration-resistant disease (mCRPC), where treatment
 options are limited, leading to an unmet need. The paradigm shift in the treatment of
 metastatic hormone-sensitive prostate cancer (mHSPC) has affected the treatment landscape for
 mCRPC patients. Many have already received androgen deprivation therapy (ADT) and androgen
 receptor pathway inhibitors (ARPI), making first-line mCRPC treatment challenging.
 
 The Swiss Group for Clinical Cancer Research (SAKK) has shown in previous studies that
 maintenance treatment with an ARPI, such as darolutamide, can improve radiographic
 progression-free survival (rPFS) in pretreated mCRPC patients. In the SAKK 08/16 trial,
 darolutamide maintenance was found to prolong PFS compared to placebo, especially in patients
 who responded well to prior ARPI treatment.
 
 Based on these findings, the hypothesis is that continued AR-pathway blockade with
 darolutamide, initiated in patients progressing from mHSPC to mCRPC on ARPI treatment, can
 improve outcomes when added to standard first-line mCRPC therapy and continued as
 maintenance. The proposed study aims to evaluate the efficacy of darolutamide, combined with
 physician-choice standard of care (including taxane chemotherapy, olaparib, radium 223, or
 LuPSMA), followed by maintenance therapy, on rPFS for patients in the first-line setting of
 mCRPC.

ICD-10 Classifications