Plain Language Summary: Can Declines in Prostate-Specific Antigen Level Indicate How Long Patients with Advanced Prostate Cancer Will Live When Treated with Enzalutamide?

Abstract

What is this summary about?

This is a summary of a research article originally published in the Journal of Urology.

The PROSPER study involved men who had a type of advanced prostate cancer called non-metastatic castration-resistant prostate cancer (nmCRPC). In patients with nmCRPC, their prostate cancer keeps growing even after traditional hormone treatments. In these patients, rising prostate-specific antigen (PSA) levels suggest that cancer is active but CT and bone scans show that it has not spread to other parts of the body. Everyone in this study received androgen deprivation therapy (ADT) either with the medicine enzalutamide or a placebo. Enzalutamide is a medicine that can slow or stop androgens, such as testosterone, from making prostate cancer grow.

The main results of the PROSPER study showed that patients with nmCRPC treated with enzalutamide and ADT lived longer than patients treated with placebo and ADT.

In this study, researchers wanted to know if the findings were different depending on how much patients' PSA level declined after enzalutamide treatment. Researchers also wanted to know if this made a difference in how long patients lived without the cancer spreading to other parts of their body.

What were the results?

Researchers found that patients with a large decline in PSA level after treatment were more likely to live longer and without their cancer spreading.

What do the results mean?

This study shows a link between PSA level changes and how long patients with nmCRPC live when treated with enzalutamide and ADT.

These results may help health professionals monitor patients with different PSA level changes after enzalutamide treatment. Patients with a large decline in PSA level may not need to be monitored as closely as patients with a small decline in PSA level.

This is an abstract of the Plain Language Summary of Publication article.

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Link to original article here

Keywords::

• advanced prostate cancer
• androgen deprivation therapy
• enzalutamide
• lay summary
• nonmetastatic castration-resistant prostate cancer
• overall survival
• plain language summary
• prostate-specific antigen

Who sponsored this study?

This study was sponsored by Pfizer Inc. and Astellas Pharma Inc., the developers of enzalutamide.

Pfizer Inc., 66 Hudson Boulevard, Hudson Yards, Manhattan, New York, NY 10001 Phone: [phone]

Astellas Pharma Inc., 1 Astellas Way, Northbrook, IL 60062–6111 Phone: [phone]

Acknowledgments

The authors and sponsors would like to thank everyone who contributed to this study.

Writing support for this summary was provided by Roham Sadeghimakki and Kirstie Anderson of Onyx (a Prime Global agency) and funded by both sponsor companies.

Financial & competing interests disclosure

M Hussain: reported consulting for Bristol-Myers Squibb, Daiichi Sankyo, Janssen, and Pfizer; honoraria from Astellas Pharma, AstraZeneca, MLI PeerView, OncLive, PER, Philips Gilmore Oncology, Projects in Knowledge, Research to Practice, Sanofi Genzyme, UroToday, Precisca, Merck, Reach MD, and Web MD; research funding from AstraZeneca, Bayer, Genentech, PCCTC, Pfizer (UM-Inst), and Arvinas; intellectual property/royalties holder for Exelexis.

CN Sternberg: reported consulting for Janssen-Cilag, Astellas Pharma, Sanofi–Genzyme, Bayer, Pfizer, Merck, MSD, AstraZeneca, Clovis, Immunomedics (now Gilead), BMS, Foundation Medicine, UroToday, Medscape, and the NCI; institutional funding from Cougar Biotechnology (now Janssen), Medivation (now Pfizer), Clovis Oncology, and Roche-Genentech.

E Efstathiou: reported honoraria from Janssen-Cilag, Sanofi, and Takeda; consulting for Janssen-Cilag, Genentech, Sanofi, Astellas Pharma, Bayer, AstraZeneca, Merck Sharp & Dohme, Innocrin Pharma, Takeda, Tolmar, ORIC Pharma, and Myovant; research funding from Janssen-Cilag, Sanofi, ORIC Pharma, and Astellas Pharma.

K Fizazi: reported consulting for Janssen Oncology, Bayer, Astellas Pharma, Sanofi, Orion Pharma GmbH, CureVac, AstraZeneca, ESSA, Roche-Genentech, Clovis Oncology, and Amgen; travel/accommodation expenses from Amgen; honoraria from Janssen, Sanofi, Astellas Pharma, and Merck.

Q Shen: employee and stockholder of Pfizer Inc.

X Lin: employee and stockholder of Pfizer Inc.

J Sugg: employee of Astellas Pharma Inc.; stock ownership in AstraZeneca.

J Steinberg: former employee of Astellas Pharma Inc.; immediate family member with stock ownership in Amgen.

B Noerby: reported no disclosures.

U De Giorgi: reported consulting for Janssen, Astellas Pharma, Sanofi, Bayer, Pfizer, BMS, Novartis, Ipsen, and Merck; institutional funding from Roche, Sanofi, and AstraZeneca.

ND Shore: reported receiving grant support and consulting for AbbVie, Amgen, Astellas Pharma, Bayer, Dendreon Pharmaceuticals, Ferring Pharmaceuticals, Janssen Oncology, Pfizer, Sanofi–Genzyme, and Tolmar Pharmaceuticals.

F Saad: reported consulting for Astellas Pharma, Janssen Oncology, Sanofi, and AstraZeneca/MedImmune; honoraria from Astellas Pharma, Janssen Oncology, Sanofi, Bayer, and AstraZeneca; institutional funding from Astellas Pharma, Bayer, Janssen Oncology, Sanofi, and AstraZeneca.