In July 2019, darolutamide became the newest available oral androgen receptor inhibitor approved by the FDA for the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC) patients. The Phase 3 ARAMIS trial evaluated darolutamide with androgen deprivation therapy (ADT) versus ADT plus placebo for nmCRPC patients and demonstrated significant improvement in metastasis-free survival (MFS), extending MFS to 40 months for those treated with darolutamide as opposed to 18 months for patients randomized to the ADT + placebo arm.

Novel approaches for the treatment of nmCRPC are now NCCN recommended, as the preferred approach to thwart prostate cancer progression for nmCRPC patients. With the awareness of a rising PSA with castrate levels of testosterone, and a lack of metastases with CT and Bone scan imaging, novel oral AR inhibitors will improve MFS., thus the importance of routine and appropriate PSA monitoring with attendant radiographic imaging. Darolutamide’s approval, licensed with the commercial name, Nubeqa, provides the arrival of another important therapeutic option for extending MFS in nmCRPC patients.

Androgen deprivation therapy (ADT) is the backbone of therapy for advanced prostate cancer patients who have failed primary interventional therapy.  Most of these patients will develop, through a potential multitude of resistance mechanisms, neoplastic cellular progression, and proliferation which subsequently leads to PSA relapse.2 Castration-resistant prostate cancer (CRPC), a rising PSA with castrate levels of testosterone alongside no radiographic imaging findings with conventional imaging (CT/Bone scans) are designated as non-metastatic (nmCRPC), or sometimes as M0CRPC.
Welcome to the timely new nmCRPC prostate cancer (nmCRPC) Center of Excellence.

Until February 2018 and the milestone ASCO GU presentations of the Phase III trials, A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN) and Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER),