EAU18 - Copenhagen. PROSPER Trial.

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[The European Association of Urology [EAU] annual meeting took place in Copenhagen last month.]

"EAU 2018: Patient-Reported Outcome Measures in Men with Non-Metastatic Castration-Resistant Prostate Cancer: Baseline Data from the PROSPER Trial

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). There was a 71% risk reduction of metastases; MFS was 36.6 months in the ENZA arm compared to just 14.7 months in the placebo arm.

Dr. Tombal, one of the co-authors, presented the patient-reported outcomes (PROs) from the study. The emphasis is on health-related quality of life (HRQOL), as it has been demonstrated to be associated with overall and progression-free survival – even in the setting of prostate cancer (TERRAIN and PREVAIL trials). As metastatic prostate cancer can be associated with significant symptoms, patient reported outcomes is just as important as oncologic outcomes.

PRO measures were assessed at baseline and every 16 weeks (4 months) while on treatment. HRQOL assessments included Brief Pain Inventory Short Form (BPI-SF), Functional Assessment of Cancer Therapy – Prostate (FACT-P), and EQ-5D-5L (a validated European QOL assessment). The analysis was done all patients in the intent-to-treat population (all patients randomized, whether they got assigned treatment or not).

Herein, the baseline data is presented. While much of the information is in tables on the poster, key findings are below.

Demographics

Median age of the population was 74, but ~50% of the population was older than 75

Patients were predominantly from Europe

>75% had ECOG 0 – fully functional, no limitations

Majority (89%) did not use bone targeting agents at baseline

These were high-risk patients, >75% had PSADT <6 months

54% had prior prostate surgical procedure, 45% did not

>94% of the population completed all 3 baseline PROs

BPI-SF

73.5% were asymptomatic at baseline, and only 14.6% were severely symptomatic

Median score was 0 (scored from 0-10)

FACT-P

Total and 4 sub-section (physical well-being, social/family well-being, functional well-being, emotional well-being) all indicated that patients had HRQOL at baseline

Median total score 121.2 (scored from 0-156, range 39.2-155)

Baseline scores comparable to non-metastatic CRPC and mCRPC chemo-naïve patients in STRIVE, TERRAIN, PREVAIL studies

PatientReportedOutcomefs PROSPER 1

EQ-5D-5L

Also demonstrated high baseline function

Median utility index score was 0.94 (0-1.0)

36.7% actually reported the best possible health score – compares favorably to 47.6% in a general population assessment

PatientReportedOutcomefs PROSPER 2

Ultimately, this assessment of the baseline characteristics demonstrate that, for the most part, cM0 CRPC patients are quite asymptomatic and have good baseline HRQOL. Treatment strategies should aim to effectively treat disease without compromising this QOL.

Presented by: Bernard Tombal, MD

Co-Authors: Hussain M., Penson D., Attard G., Sternberg C.N., Phung D., Naidoo S., Modelska K., Demirhan E., Ramaswamy K., Ivanescu C., Saad F.

Written by: Thenappan Chandrasekar, MD Clinical Fellow, University of Toronto, twitter: @tchandra_uromd at the 2018 European Association of Urology Meeting EAU18, 16-20 March, 2018 Copenhagen, Denmark

Read More:

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

Prostate-Specific Antigen Response in Men with Nonmetastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide: Results from PROSPER

Watch: Meeting an Unmet Need in the Non-Metastatic Castration Resistant Prostate Cancer Patient Population - Maha Hussain

Watch: Discussion on PROSPER: Safety and Efficacy Study of Enzalutamide in Patients with nmCRPC - Thomas Keane

TAGS: mCRPC Treatment COE

-Patrick

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