(Length of Discussion: 25 min)

Professor Eric Small, MD talks with Dr. Neal Shore in a post ASCO GU interview on Dr. Eric Small’s plenary presentation on the phase three global SPARTAN trial. A landscape changing treatment for patients with non-metastatic castration resistant prostate cancer.  The first drug approved by FDA to satisfy an unmet need for nmCRPC or m0 patients.

Dr. Eric Small gives an overview of the SPARTAN trial of apalutimide, a novel next generation non steroidal anti androgen to prevent metastases.  The primary endpoint of this study was metastases free survival (MFS). Patients were randomized in a two to one fashion to receive apalutimide or the matched placebo, administered orally and continued on therapy protocol defined radiographic progression, adverse advents or withdrawal consent.  Bone scans and cat scans were performed every 16 weeks as well as independent central reviews.  PSA values were maintained blinded so that patients remained so patients remained on study until developing metastasis.  Dr. Small report that only 10-12% of patients withdrew from the study prior to that point.  After developing metastasis patients were treated with physician digression with an option to receive study provided abiraterone which was to try to make sure as many patients as possible once they developed metastasis received a standard of care, abiraterone, enzalutimide or other life prolonging drugs.  About 80% of patients that came off treatment at this point received secondary treatment which makes physicians, researchers, and patients more comfortable of the longer term effects of this therapy. 

Dr. Eric Small reviews a number of secondary endpoints including time to symptomatic progression and overall survival (OS) even though it was very early for the secondary endpoint of OS.

The study was primarily positive with the median MFS was 40.5 months in the apalutimide arm compared with 16.2 in the placebo group, a 72% risk reduction and a highly significant P value, therefore showing if you use apalutimide for these patients that you can dramatically reduce the risk  of metastasis or prolong the time that metastasis are observed by more than 2 years. 

Biographies: Eric J. Small, MD Professor of Medicine; Urology; and Chief, Department of Medicine/Division of Hematology/Oncology, UCSF
Deputy Director; Program Leader, Prostate Cancer Program, UCSF Helen Diller Family Comprehensive Cancer Center
Doris and Donald Fisher Distinguished Professorship in Clinical Cancer Research; Stanford W. Ascherman and Norman R. Ascherman Endowed Chair, UCSF

Neal Shore, MD, FACS

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First Presentation - SPARTAN: A Study of Apalutamide (ARN-509) in Men with Non-Metastatic Castration-resistant Prostate Cancer

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