Key inclusion criteria for men enrolling in SPARTAN included:
- Histologically confirmed adenocarcinoma of the prostate, castration-resistant
- High risk of developing metastasis: PSA doubling time of 10 months or less during continuous ADT
- Negative bone scan and CT of the pelvis, abdomen, chest, and head
The summary of the patients that developed metastases is as follows:
- Nodal: apalutamide 30% (52/175) vs placebo 40% (76/191)
- Bone: apalutamide 57% (100/175) vs placebo 52% (100/191)
- Visceral: apalutamide 13% (23/175) vs placebo 8% (15/191)
In addition to the remarkable 72% reduction in risk of metastases that gained apalutamide FDA approval for the treatment of men with nmCRPC, the results from the current study solidify that apalutamide markedly decreased the risk of time to metastases regardless of the site of metastasis. Dr. Smith concluded that the consistency of these results provides further evidence for the clinical benefit of apalutamide in men with nmCRPC.
Clinical trial information: NCT01946204
Presented by: Matthew R. Smith, Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA
Co-Authors: Fred Saad, Dana E. Rathkopf, Boris A. Hadaschik, Simon Chowdhury, Margaret K. Yu, Angela Lopez-Gitlitz, Oliver Brendan Rooney, Mohamed Darif, Eric Jay Small; Centre Hospitalier de l’Université de Montréal/CRCHUM, University of Montréal, Montréal, QC, Canada; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY; University of Duisburg-Essen, Essen, Germany; Guy's, King's and St Thomas' Hospitals, London, United Kingdom; Janssen Research & Development, Los Angeles, CA; Janssen Research & Development, High Wycombe, United Kingdom; Janssen Research & Development, San Diego, CA; Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre @zklaassen_md at the 2018 ASCO Annual Meeting - June 1-5, 2018 – Chicago, IL USA
WATCH: Erc Small Present: SPARTAN - a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC)
1. Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med 2018;378(15):1408-1418.