I covered this yesterday, but here is the Abstract:,
I can't get the table to copy, so here is a summary:
median MFS: 36.6 versus 14.7 months
median time to new treatment: 39.6 versus 17.7 months
To see the full table, go to the 3rd Abstract:
gucasym.org/sites/gucasym.o...
-Patrick
3 Oral Abstract Session, Thu, 1:00 PM-2:30 PM and Poster Session
(Board #A4), Thu, 11:30 AM-1:00 PM and 5:15 PM-6:15 PM
PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC).
Maha Hussain, Karim Fizazi, Fred Saad, Per Rathenborg, Neal D. Shore, Eren Demirhan, Katharina Modelska, De Phung, Andrew Krivoshik, Cora N. Sternberg; Northwestern University, Chicago, IL; Institut Gustave Roussy, University of Paris Sud, Cancer Medicine, Villejuif, France; Centre Hospitalier de l’Universite ́ de Montre ́al/CRCHUM, Montreal, QC, Canada; Herlev Hospital, Herlev, Denmark; Carolina Urologic Research Center, Myrtle Beach, SC; Pfizer, Inc., San Francisco, CA; Pfizer, Inc., San Francisco, CA, US; Astellas Pharma Inc., Leiden, Netherlands; Astellas Pharma Inc., Northbrook, IL; San Camillo Forlanini Hospital, Rome, Italy
Background: Men with M0 CRPC and rapidly rising prostate-specific antigen (PSA) are at high risk of developing metastatic (M1) CRPC. ENZA improves overall survival (OS) and radiographic progression- free survival in men with M1 CRPC. We hypothesized that ENZA will improve metastasis-free survival (MFS) in men with M0 CRPC.
Methods: Eligible men with M0 CRPC, PSA doubling time # 10 mo and PSA $ 2 ng/mL at screening continued androgen deprivation therapy (ADT) and were randomized 2:1 to ENZA 160 mg or PBO. The primary endpoint was MFS. Secondary endpoints included time to PSA progression, time to first use of new antineoplastic therapy, OS and safety.
Results: In 1401 men, ENZA significantly prolonged median MFS (36.6 mo vs 14.7 mo [P , .0001]), time to first use of new antineoplastic therapy (39.6 mo vs 17.7 mo [P , .0001]) and time to PSA progression (37.2 mo vs 3.9 mo [P , .0001]) compared to PBO (Table). In the first interim analysis of OS there was a trend in favor of ENZA (hazard ratio [HR] = 0.80; P = .1519). Median duration of treatment was 18.4 mo vs 11.1 mo for ENZA vs PBO. Adverse events (AEs) were higher with ENZA vs PBO (any grade: 87% vs 77%; grade $ 3: 31% vs 23%; serious: 24% vs 18%); 10% with ENZA discontinued treatment due to AE vs 8% with PBO. Conclusions: In men with M0 CRPC and rapidly rising PSA, ENZA treatment resulted in a clinically meaningful and statistically significant 71% reduction in the risk of developing M1 CRPC. AEs were consistent with the established safety profile of ENZA. Clinical trial information: NCT02003924.
