AUA 2018: PROSPER Study Results: Impact of Enzalutamide on Pain and Health-Related Quality of Life in Men with nmCRCP

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. Patients were randomized 2:1. The study showed a statistically significant improvement in metastasis-free survival (MFS) with ENZA vs PBO. PROSPER also prospectively evaluated health-related quality of life (HRQoL) and pain.

HRQoL and pain were assessed at baseline and then every 16 weeks using validated tools: Functional Assessment of Cancer Therapy-Prostate (FACT-P), Quality-of-life Questionnaire, Prostate (QLQ-PR25), EuroQol 5-domain, 5-level (EQ-5D-5L), and Brief Pain Inventory-Short Form (BPI-SF). Patients with baseline and 1 post-baseline evaluable forms were analyzed. Changes in scores from baseline over 96 weeks were analyzed using mixed models repeated measures. The time point for this analysis was based on the assumed median MFS for the PBO arm; thus, reducing the impact of missing data due to discontinuation of treatment. In this study, the authors report results for FACT-P and BPI-SF.

Median treatment duration was 18.4 months (ENZA) and 11.1 months (PBO). Completion rates for all instruments were high for patients remaining on study (>85% for all visits). Unadjusted completion rates dropped more in PBO due to attrition and continuous recruitment of patients up to the database lock (at week 97, 20% in PBO and 39% in ENZA patients reported HRQoL and pain data). Baseline scores were similar between arms with low levels of pain and high HRQoL (patients at 71- 90% of the scale range; as can be seen in the table below). Overall, there was no statistically significant nor clinically meaningful difference in effect on HRQoL or pain between ENZA and PBO, despite certain adverse events being more common in patients on ENZA. Nonetheless, there was a trend favoring ENZA for all domains except physical well-being. A nominally statistically significant difference in favor of ENZA was observed for social well-being. 

UroToday AUA2018 PROSPER NCT02003924 impact of Enza

In conclusion, In the PROSPER study, ENZA was shown to compare to PBO over a 96 weeks period. Enza maintains HRQoL with the minimal decline since there were no physical disease-related effects at baseline while providing significant treatment benefit on MFS.


Presented by: Fred Saad, MD, FRCS, University of Montreal Hospital Center
Co-Author: David Penson, Nashville, TN, Gerhardt Attard, Surrey, United Kingdom, Maha Hussain, Chicago, IL, Cora Sternberg, Rome, Italy, Shevani Naidoo, Chertsey, United Kingdom, Katharina Modelska, Eren Demirhan, San Francisco, CA, Krishnan Ramaswamy, New York, NY, Konstantina Skaltsa, Barcelona, Spain, Bertrand Tombal, Brussels, Belgium

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA

Read More: First Presentation - PROSPER: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC)

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