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PROSPER Trial: Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

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Preliminary trial results showed that enzalutamide significantly improved metastasis-free survival among men who had nonmetastatic, castration-resistant prostate cancer and rapidly increasing prostate-specific antigen (PSA) levels while taking androgen-deprivation therapy. Results from the final analysis of overall survival have not yet been reported.
San Francisco, CA (UroToday.com) -- Astellas Pharma Inc. and Pfizer Inc. announced the results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC).

Men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising prostate-specific antigen (PSA) level are at high risk for metastasis. We hypothesized that enzalutamide, which prolongs overall survival among patients with metastatic, castration-resistant prostate cancer, would delay metastasis in men with nonmetastatic, castration-resistant prostate cancer and a rapidly rising PSA level.

In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study.

Truckee, CA (UroToday.com) - Pfizer Inc. and Astellas Pharma Inc. announced that the Phase 3 PROSPER trial evaluating XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS). The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials.
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Conference Highlights from Recent Conference Coverage
Presented by Maha H. A. Hussain, MD, FACP, FASCO
To provide guidance on expected outcomes and explore the influence of PSA dynamics further, in a plenary abstract presentation in the Poster Highlights Session: Prostate Cancer session at the 2021 ASCO GU Cancers Symposium, Dr. Hussain and colleagues presented an analysis of overall survival and metastasis-free survival among patients in the PROSPER trial according to the depth of PSA response.
Presented by Ugo De Giorgi
In a plenary abstract presentation at the 2021 ASCO GU Cancers Symposium, Dr. De Giorgi and colleagues presented a subgroup analysis of the PROSPER trial examining the effect of age and region on overall survival and safety outcomes.
In the second Prostate Cancer session at this year’s Society of Urologic Oncology virtual annual meeting, Dr. Sternberg provided an update on the PROSPER trial of enzalutamide in patients with non-metastatic castration resistant prostate cancer.
Presented by Maha Hussain, MD, FACP, FASCO
There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) since the spring of 2018. Up until the presentation of SPARTAN and PROSPER trials, reporting on the use of apalutamide and enzalutamide in non-metastatic castration-resistant prostate cancer
Presented by Cora N. Sternberg, MD, FACP
(UroToday.com) There has been a rapid evolution in treatment options for patients with non-metastatic castration-resistant prostate cancer since the spring of 2018. Up until the presentation of SPARTAN and PROSPER trials, reporting on the use of apalutamide 
Presented by Cora N. Sternberg, MD, FACP
Enzalutamide is an FDA approved androgen receptor antagonist used in the treatment of essentially every phase of advanced prostate cancer, from metastatic hormone-sensitive prostate cancer to metastatic and non-metastatic castration-resistant prostate cancer.
Presented by Karim Fizazi, MD, Ph.D
Munich, Germany (UroToday.com) During GU ASCO 2018, Dr. Hussain presented the results of PROSPER (NCT02003924), a phase III randomized, double-blind, placebo-controlled study of enzalutamide in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC)1.
Presented by Gerhardt Attard, MD, FRCP, Ph.D
Chicago, IL (UroToday.com) At the 2018 GU ASCO meeting in San Francisco, Maha Hussain, MD presented the results of PROSPER, a phase III randomized controlled trial assigning 1,401 men with non-metastatic CRPC (M0 CRPC) 2:1 to enzalutamide (160 mg) or placebo.
Presented by Fred Saad, MD, FRCS
San Francisco, CA (UroToday.com) The PROSPER trial (NCT02003924) compared the efficacy and safety of enzalutamide (ENZA) 160 mg/day vs placebo (PBO) in asymptomatic men with non-metastatic castration-resistant prostate cancer with prostate-specific antigen doubling time of 10 months.
Presented by Neal Shore, MD
San Francisco, CA USA (UroToday.com) Earlier this year, at the 2018 GU ASCO conference, the results of two major clinical trials assessing androgen-targeted therapies (ART) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC or M0 CRPC)
Presented by Bernard Tombal, MD
Copenhagen, Denmark (UroToday.com) At GU ASCO 2018, Dr. Maha Hussain presented the data from the PROSPER study, which was an incredibly important study looking at the role for enzalutamide (ENZA) in the setting of non-metastatic castration-resistant prostate cancer (nmCRPC).
Presented by Cora Sternberg, MD
Copenhagen, Denmark (UroToday.com)  Androgen deprivation therapy (ADT) is the standard treatment recommended for hormone-sensitive prostate cancer. Since their initial introduction as alternatives to docetaxel for metastatic castrate resistant prostate cancer (mCRPC)
Presented by Philip W. Kantoff, MD
San Francisco, CA (UroToday.com) The management of metastatic prostate cancer (PCa) continues to change in rapid succession. While we were once reliant on androgen deprivation therapy (ADT) for hormone-sensitive prostate cancer (hsPCa) and docetaxel alone
Presented by Maha Hussain, MD, FACP, FASCO
San Francisco, CA (UroToday.com) Dr. Maha Hussain provided the first presentation of the phase III randomized double-blind controlled trial, the following men were eligible for inclusion

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