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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

3709 - A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic (M0) castration-resistant prostate cancer (CRPC): results of PROSPER by age and region


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Cytotoxic Therapy

Tumour Site

Prostate Cancer


Karim Fizazi


Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284


K. Fizazi1, M. Hussain2, F. Saad3, N. Shore4, U. De Giorgi5, E. Efstathiou6, U. Ferreira7, P. Ivashchenko8, K. Madziarska9, M. Al-Adhami10, K. Modelska11, D. Phung12, J. Steinberg13, C.N. Sternberg14

Author affiliations

  • 1 Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, 94800 - Villejuif/FR
  • 2 Robert H. Lurie Comprehensive Cancer Center, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, 60611 - Chicago/US
  • 3 Urology, University of Montreal Hospital Center (CHUM), H2X 3J4 - Montreal/CA
  • 4 Urology, Carolina Urologic Research Center, 29572 - Myrtu Beach/US
  • 5 Uro-gynecology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 - Piero Maroncelli/IT
  • 6 Genitourinary Medical Oncology, MD Anderson Cancer Center, 77030-3721 - Houston/US
  • 7 Urologic Oncology, State University of Campinas (Unicamp), 13083-970 - Cidade Universitária Zeferino Vaz - Barão Geraldo/BR
  • 8 Urology, Kyiv City Clinical Hospital #3, 04112 - Kiev, Petra Zaporozhtza, /UA
  • 9 Department And Clinic Of Nephrology And Transplantation Medicine, Wroclaw Medical University, 50-367 - Wroclaw/PL
  • 10 Biostatistics, Pfizer Inc., 06340 - Groton/US
  • 11 Medical Oncology, Pfizer Inc., 94105 - San Francisco/US
  • 12 Biostatistics, Astellas Pharma, Inc, 23182 - Leiden/NL
  • 13 Medical Oncology, Astellas Pharma, Inc., 60062 - Northbrook/US
  • 14 Medical Oncology, San Camillo Forlanini Hospital, 156 - Roma/IT

Abstract 3709


Men with M0 CRPC are at high risk of developing metastatic (M1) CRPC. The goal of M0 CRPC treatment is to delay M1 disease progression, delay additional antineoplastic therapies, and ultimately prolong survival and maintain quality of life. In the primary analysis of PROSPER, ENZA improved metastasis-free survival (MFS) in men with M0 CRPC. Here we report results in subgroups of patients (pts) by age and region.


Eligible men with M0 CRPC, prostate-specific antigen (PSA) doubling time ≤ 10 mo and PSA ≥ 2 ng/mL at screening continued androgen deprivation therapy 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, overall survival, and safety.


1401 men were enrolled with a median age of 74 y (standard deviation, 7.8 y). Baseline characteristics were generally similar across regions and age groups (Table). Baseline use of bone-targeting agents was higher in North America compared with the other 2 regions. A greater proportion of pts aged ≥ 75 y had and ECOG PS of 1 than pts aged < 75 y. In all men, ENZA reduced the risk of metastasis or death by 71% (HR, 0.29; 95% CI, 0.24-0.35; P < 0.0001). The risk reduction with ENZA use was similar across all subgroups (Table). Safety results were generally similar among all subgroups, except that more pts in the group aged ≥ 75 y reported adverse event as the primary reason for discontinuation (13% with ENZA vs 10% with PBO) than in the overall pt population (9% with ENZA vs 6% with PBO), and more pts in North America reported falls (15%) than in Europe (7%) or rest of world (10%).Table: 805P

Overall (N = 1401)Age < 75 y (n = 756)Age ≥ 75 y (n = 645)Europe (n = 690)Rest of world (n = 507)North America (n = 204)
Baseline characteristics
Age category, no. (%) < 65 y 65 to  < 75 y ≥ 75 y190 (14) 566 (40) 645 (46)190 (25) 566 (75) 00 0 645 (100)100 (15) 285 (41) 305 (44)57 (11) 200 (40) 250 (49)33 (16) 81 (40) 90 (44)
ECOG PS, no. (%) 0 11129 (81) 270 (19)668 (88) 87 (12)461 (72) 183 (28)555 (80) 134 (19)401 (79) 105 (21)173 (85) 31 (15)
Use of bone-targeting agent, no. (%) Yes153 (11)77 (10)76 (12)74 (11)36 (7)43 (21)
PSA doubling time, median (range), mo3.7 (0.4-71.8)3.5 (0.6-28.9)4.0 (0.4-71.8)3.9 (0.4-71.8)3.5 (0.4-10.0)3.7 (0.5-14.7)
PSA doubling time < 6 mo, no. (%)1076 (77)596 (79)480 (74)510 (74)411 (81)155 (76)
MFS HR (95% CI) P value0.29 (0.24-0.35) < 0.00010.25 (0.20-0.33) < 0.00010.35 (0.26-0.47) < 0.00010.24 (0.18-0.32) < 0.00010.32 (0.23-0.43) < 0.00010.41 (0.25-0.66) < 0.0001

Abbreviation: ECOG PS, Eastern Cooperative Oncology Group Performance Status.


In men with M0 CRPC and rapidly rising PSA, ENZA treatment resulted in a clinically meaningful and statistically significant reduction of developing metastases or death. Results were consistent across subgroups of pts by age and geographic region.

Clinical trial identification


Legal entity responsible for the study

Pfizer, Inc. and Astellas Pharma, Inc.


Pfizer, Inc. and Astellas Pharma, Inc.

Editorial Acknowledgement

Medical writing and editorial support, funded by Pfizer Inc., and Astellas Pharma, Inc., was provided by Stephanie Vadasz, Ph.D., and Shannon Davis of Ashfield Healthcare Communications.


K. Fizazi: Honoraria, consultant: Amgen, Astellas, Bayer, Clovis, CureVac, Janssen, Orion, Sanofi. M. Hussain: Honoraria: Sanofi, OncLive; Travel expenses: Sanofi; Institutional research funding: AstraZeneca, Pfizer, Bayer, Genentech. F. Saad: Honoraria, institutional research funding, consultant: Janssen, Sanofi, Astellas, Bayer, Pfizer. N. Shore: Consultant: Amgen, Astellas, Bayer, Dendreon, Fleming, Janssen, Medivation, Tolmar; Participated in speakers' bureaus: Janssen, Bayer, Dendreon. U. De Giorgi: Honoraria, consultant: Astellas, Bristol-Myers Squibb, Ipsen, Janssen, Pfizer, Novartis, Sanofi. E. Efstathiou: Honoraria, research funding, advisory boards: Janssen, Sanofi, Tolmar, Pfizer, Medivation, Astellas, Bayer, AstraZeneca. M. Al-Adhami, K. Modelska: Employees: Pfizer Inc. D. Phung, J. Steinberg: Astellas, Inc. C.N. Sternberg: Honoraria, institutional research funding: Pfizer, Astellas, Sanofi, Janssen, Bayer, Clovis Oncology, Ferring. All other authors have declared no conflicts of interest.

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