Summary
What is this summary about?
This is a summary of a paper that describes the results of the SPARTAN and TITAN studies, which looked at whether a treatment called apalutamide can help treat individuals with advanced prostate cancer.
The SPARTAN study included 1207 participants with nonmetastatic castration-resistant prostate cancer (or nmCRPC). The TITAN study included 1052 participants with metastatic castration-sensitive prostate cancer (or mCSPC). Treatment with apalutamide was compared with treatment with placebo. In both studies, all participants were also given androgen deprivation therapy (or ADT), which has been used for many years for the treatment of prostate cancer.
The results showed that treatment with apalutamide plus ADT increased participants' survival time while their health-related quality of life stayed the same, compared with placebo plus ADT. Also, apalutamide plus ADT increased the length of time that the cancer did not spread to other parts of the body (metastasize) or did not continue to grow. In both studies, treatment with apalutamide plus ADT was associated with a deep decline in blood prostate-specific antigen (or PSA) levels (called a deep PSA decline). This additional analysis of the SPARTAN and TITAN studies was performed to understand whether the deep PSA decline in participants who received apalutamide plus ADT was linked to their overall health-related quality of life.
What were the results of the additional analysis?
In participants who received apalutamide plus ADT, those who achieved a deep PSA decline after the start of treatment had a greater chance that their health-related quality of life would remain stable. When participants achieved a deep PSA decline at 3 months after the start of treatment, the benefit to their health-related quality of life, including physical wellbeing, was even greater.
What do these results mean for individuals with advanced prostate cancer?
For individuals with advanced prostate cancer, it is important to monitor both PSA decline and any impacts on health-related quality of life. These results will help doctors and other healthcare professionals have a better understanding of patients' cancer experience and the impact of their treatment.
Clinical Trial Registration: NCT01946204 (SPARTAN) and, NCT02489318 (TITAN) (ClinicalTrials.gov)
Keywords: : apalutamide, castration-resistant prostate cancer, deep PSA decline, health-related quality of life, metastatic castration-sensitive prostate cancer, overall survival, plain language summary, PSA response
This is an abstract of the Plain Language Summary of Publication article.
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Link to original article here
Acknowledgments
The authors would like to thank the participants and their families for making the study possible and the investigators and the clinical study teams at Janssen Research & Development.
Financial disclosure
The SPARTAN and TITAN studies were sponsored by Janssen Research & Development, LLC, a Johnson & Johnson company. LI Karsh reports consultancy to AbbVie, AstraZeneca, Astellas, Bayer, Bristol Myers Squibb, Dendreon, Ferring, FKD Therapies, Janssen, Merck, Pfizer and Sanofi; research funding to institution from AstraZeneca, Astellas, Bayer, Bristol Myers Squibb, Cleveland Dx, Epizyme, Ferring, FKD Therapies, Janssen, OncoCell MDx, Merck, Pfizer and Sumitomo Pharma. KB Bevans reports employment by and stock ownership in Janssen Pharmaceuticals. F Saad reports consultancy to Astellas, AstraZeneca, Bayer, Janssen and Pfizer; research funding to institution from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Pfizer, and Sanofi; and honorarium from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Janssen, Pfizer and Sanofi. BH Chung reports consultancy to Amgen (Korea), Astellas (Korea), Ipsen (Korea), Hondok (Korea), Jansen (Korea), JW Pharma (Korea) and Takeda (Korea); research funding (self) from AstraZeneca (UK), Bayer (Germany), Janssen (USA), Mivyovant Sciences GmbH (Australia), Pfizer (USA) and Roche (Switzerland); and honorarium from Astellas (Korea), Ipsen (Korea), JW Pharma (Korea), Takeda (Korea) and Sanofi (Japan). S Oudard reports honorarium from AstraZeneca, Astellas, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck, Novartis, Pfizer and Sanofi. SD Brookman-May reports employment by and stock ownership in Janssen Pharmaceuticals. SA McCarthy reports employment by and stock ownership in Janssen Pharmaceuticals. MR Smith reports consultancy to Amgen, Bayer, Gilead, Janssen, Lilly, Novartis and Pfizer; and research funding (self) from Bayer, Gilead and Janssen. KN Chi reports consultancy to Janssen, Astellas, Essa, Sanofi, Bayer, Roche, AstraZeneca, Daiichi Sankyo, Novartis, Pfizer, Merck, Bristol Myers Squibb and Point Pharma; and research funding to institution from Janssen, Astellas and Sanofi; and honorarium from Janssen, Astellas, Bayer, AstraZeneca, Merck and Pfizer. EJ Small reports consultancy to Fortis and Janssen; research funding (self) from Janssen, Merck Sharp & Dohme; and being a shareholder in Fortis and Harpoon Therapeutics. N Agarwal reports lifetime consultancy to Astellas, AstraZeneca, Aveo, Bayer, Bristol Myers Squibb, Calithera, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation Medicine, Genentech, Gilead, Janssen, Merck, MEI Pharma, Nektar, Novartis, Pfizer, Pharmacyclics and Seattle Genetics; research funding to institution from Astellas, AstraZeneca, Bavarian Nordic, Bayer, Bristol Myers Squibb, Calithera, Celldex, Clovis, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, Glaxo Smith Kline, Immunomedics, Janssen, Medivation, Merck, Nektar, New Link Genetics, Novartis, Pfizer, Prometheus, Rexahn, Roche, Sanofi, Seattle Genetics, Takeda and Tracon. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Competing interests disclosure
LI Karsh reports serving as a speaker for AstraZeneca, Astellas, Bayer, Janssen, Merck and Pfizer. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
Professional writing support for this summary was provided by Ann Tighe, PhD, and Breanne Landry, PhD, of Parexel, funded by Janssen Global Services, LLC.