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SPARTAN, PROSPER and ARAMIS: 2020 Update

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Non-metastatic castration-resistant prostate cancer (nmCRPC) affects at least 110,000 patients in the United States each year, comprises 1% to 2% of prostate cancers worldwide, and is a significant risk factor for progression to overt metastatic disease and cancer-related death.1,2 Amidst the many challenges of 2020, a bright spot has been the reporting of final overall survival (OS) data from the registrational SPARTAN, PROSPER, and ARAMIS trials, which confirm that for appropriately selected patients with high-risk nmCRPC, treatment with a next-generation androgen receptor (AR) inhibitor, whether apalutamide, enzalutamide, or darolutamide, significantly prolongs both metastasis-free survival (MFS) and overall survival (OS). It is remarkable that we now have three approved therapies for a disease state wherein, just three years ago, there was no level 1 evidence for an approved therapeutic. Herein, I will review the new efficacy and safety data and clinical implications for these recently approved nmCRPC agents.

The Efficacy of Darolutamide for Non Metastatic Castration-Resistant Prostate Patients

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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.

An Update on Nonmetastatic Castration-Resistant Prostate Cancer

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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.

From the Desk of the Editor

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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),