A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer


Condition: Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate

Intervention:

  • Drug: Enzalutamide
  • Drug: Placebo

Purpose: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02003924

Sponsor: Pfizer

Primary Outcome Measures:

  • Measure: Metastasis Free Survival (MFS)
  • Time Frame: ≥ 16 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Time to Prostate-Specific Antigen (PSA) Progression
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Time to First Use of New Antineoplastic Therapy
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Time to First Use of Cytotoxic Chemotherapy
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: FACT-P Global Score
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Quality of Life as assessed by EQ-5D-5L and QLQ-PR25
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Time to chemotherapy-free disease specific survival
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Time to chemotherapy-free survival
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Time to pain progression
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug
  • Time Frame: ≥ 16 weeks
  • Safety Issue:
  • Measure: PSA response rates
  • Time Frame: ≥ 16 weeks
  • Safety Issue:

Estimated Enrollment: 1440

Study Start Date: December 2013

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
  • Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
  • Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
  • Progressive disease on androgen deprivation therapy at enrollment;
  • PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
  • PSA doubling time ≤ 10 months;
  • No prior or present evidence of metastatic disease;
  • Asymptomatic prostate cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Estimated life expectancy ≥ 12 months.

Exclusion Criteria:

  • Prior cytotoxic chemotherapy;
  • Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive cancer within 3 years of randomization;
  • Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
  • Total bilirubin ≥ 1.5 times the upper limit of normal;
  • Creatinine > 2 mg/dL (177 µmol/L) at screening;
  • Albumin < 3.0 g/dL (30 g/L) at screening;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks of randomization;
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
  • Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

Contact:

  • Pfizer CT.gov Call Center
  • 1-800-718-1021

Locations:

  • Tucson Arizona 87541 United States
  • Los Angeles California 90095 United States
  • Orange California 92868 United States
  • Englewood Colorado 80113 United States
  • New Haven Connecticut 06520 United States
  • Lakeland Florida 33805 United States
  • Indianapolis Indiana 46202 United States
  • Jeffersonville Indiana 47130 United States
  • Lafayette Indiana 47904 United States
  • Lenexa Kansas 66214 United States
  • Wichita Kansas 67226 United States
  • Baltimore Maryland 21229 United States
  • Ann Arbor Michigan 48109 United States
  • Troy Michigan 48084 United States
  • Omaha Nebraska 68130 United States
  • Brooklyn New York 11215 United States
  • Newburgh New York 12550 United States
  • Gastonia North Carolina 28054 United States
  • Raleigh North Carolina 27607 United States
  • Middleburg Heights Ohio 44130 United States
  • Springfield Oregon 97477 United States
  • Lancaster Pennsylvania 17604 United States
  • Myrtle Beach South Carolina 29572 United States
  • Nashville Tennessee 37232 United States
  • San Antonio Texas 78229 United States
  • Virginia Beach Virginia 23462 United States
  • Berazategui Buenos Aires B1880BBF Argentina
  • Rosario Santa Fe 2000 Argentina
  • Buenos Aires C1019ABS Argentina
  • Caba C1181ACH Argentina
  • Ciudada Autonoma de Buenos Aires C1120AAT Argentina
  • Cordoba 5016 Argentina
  • Cordoba X5004FHP Argentina
  • La Rioja F5300COE Argentina
  • Santa Fe S2000KZE Argentina
  • Garran Australian Capital Territory 2605 Australia
  • Concord New South Wales 2139 Australia
  • Lismore New South Wales 2480 Australia
  • New Lambton Heights New South Wales 2305 Australia
  • North Ride New South Wales 2109 Australia
  • Port Macquarie New South Wales 2444 Australia
  • St Leonards New South Wales 2065 Australia
  • Tweed Heads New South Wales 2485 Australia
  • Wahroonga New South Wales 2076 Australia
  • Waratah New South Wales 2298 Australia
  • Westmead New South Wales 2145 Australia
  • South Brisbane Queensland 4101 Australia
  • Southport Queensland 4215 Australia
  • Woolloongabb Queensland 4102 Australia
  • Kurralta Park South Australia 5037 Australia
  • Bentleigh East Victoria 3165 Australia
  • Box Hill Victoria 3128 Australia
  • East Melbourne Victoria 3002 Australia
  • Footscray Victoria 3011 Australia
  • Heidelberg Victoria 3084 Australia
  • Malvern Victoria 3144 Australia
  • Wodonga Victoria 3690 Australia
  • Roeselare 8800 Australia
  • Linz 4010 Austria
  • Vienna 1090 Austria
  • Vienna 1170 Austria
  • Bruxelles 1070 Belgium
  • Bruxelles 1200 Belgium
  • Gent 9000 Belgium
  • Kortrijk 8500 Belgium
  • Leuven 3000 Belgium
  • Liege 4000 Belgium
  • Mons 7000 Belgium
  • Salvador Bahia 41253 Brazil
  • Curtiba Parana 81520-060 Brazil
  • Ljui Rio Grande do Sul 98700-000 Brazil
  • Passo Fundo Rio Grande do Sul 99074-450 Brazil
  • Porto Alegre Rio Grande do Sul 90035-074 Brazil
  • Porto Alegre Rio Grande do Sul 90035-903 Brazil
  • Campinas Sao Paulo 13083-888 Brazil
  • Santo Andre Sao Paulo 09060-650 Brazil
  • Rio de Janeiro 20551-030 Brazil
  • Rio de Janiero 22260-020 Brazil
  • Sao Paulo 05652-900 Brazil
  • Sao Paulo 17210-120 Brazil
  • Calgary Alberta T2S 3C3 Canada
  • Edmonton Alberta T6G 1Z2 Canada
  • Vancouver British Columbia V5Z 1M9 Canada
  • Winnipeg Manitoba R3E 0V9 Canada
  • Halifax Nova Scotia B3H2Y9 Canada
  • Barrie Ontario L4M 7G1 Canada
  • Hamilton Ontario L8N 4A6 Canada
  • Kitchener Ontario N2N 2B9 Canada
  • London Ontario N6A 4L6 Canada
  • Toronto Ontario M4N 3M5 Canada
  • Toronto Ontario M5G 2M9 Canada
  • Greenfield Park Quebec J4V 2H3 Canada
  • Montreal Quebec H2L 4M1 Canada
  • Montreal Quebec H3G 1A4 Canada
  • Québec City G1R 2J6 Canada
  • Talcahuano Concepcion 4270918 Chile
  • Santiago 7500921 Chile
  • Santiago 7630370 Chile
  • Temunco 4810469 Chile
  • Vina del Mar 2540364 Chile
  • Beijing Beijing 100034 China
  • Beijing Beijing 100142 China
  • Beijing Beijing 100191 China
  • Nanjing Jiangsu 210009 China
  • Suzhou City Jiangsu 215004 China
  • Wuxi Jiangsu 214023 China
  • Shanghai Shanghai 200032 China
  • Shanghai Shanghai 200040 China
  • Shanghai Shanghai 200080 China
  • Shanghai Shanghai 200092 China
  • Xi'an Shanxi 710061 China
  • Tianjin Tianjin 300211 China
  • Hangzhou Zhejiang 310009 China
  • Wenzhou Zhejiang 325000 China
  • Beijing 100032 China
  • Beijing 100730 China
  • Chongqing 400030 China
  • Guangdong 510150 China
  • Guangzhou 510120 China
  • Nanjing 210008 China
  • Nanjing 210029 China
  • Wuhan 430071 China
  • Copenhagen 2200 N Denmark
  • Frederiksberg 2000 Denmark
  • Herlev 2730 Denmark
  • Odense 5000 Denmark
  • Århus 8200 Denmark
  • Helsinki 180 Finland
  • Helsinki 290 Finland
  • Oulu 90220 Finland
  • Pori 28500 Finland
  • Tampere 33520 Finland
  • Strasbourg Bas-Rhin 67000 France
  • Bordeaux Cedex Gironde 33076 France
  • Toulouse Cedex Haute Garonne 31052 France
  • Toulouse Haute Garonne 31076 France
  • Saint Herblain Loire Atlantique 44805 France
  • Lille Cedex Nord 59037 France
  • Lyon Rhone 69437 France
  • Pierre Benite Cedex Rhone 69495 France
  • Strasbourg Rhone 67091 France
  • Le Mans Sarthe 72000 France
  • Rouen Upper Normandy 76000 France
  • Villejuif Cedex Val de Marne 94805 France
  • Poitiers Vienne 86021 France
  • Angers Cedex 9 49933 France
  • Avignon 84918 France
  • Brest 29609 France
  • Dijon 2100 France
  • Limoges 87042 France
  • Lyon Cedex 69003 France
  • Lyon 69009 France
  • Montpellier 34298 France
  • Paris Cedex 15 75908 France
  • Paris 75248 France
  • Vandoeuvre les Nancy 54511 France
  • Nuertingen Baden-Württemberg 72622 Germany
  • Tubingen Baden-Württemberg 72076 Germany
  • Weiden Bavaria 92637 Germany
  • Braunschweig Lower Saxony 38126 Germany
  • Leer Niedersachsen 26789 Germany
  • Dresden Saxony 1307 Germany
  • Berlin 12200 Germany
  • Hamburg 20246 Germany
  • Athens 11526 Greece
  • Athens 11528 Greece
  • Crete 71201 Greece
  • Larisa 41110 Greece
  • Thessaloniki 56403 Greece
  • Hong Kong Hong Kong
  • Pokfulam Hong Kong
  • Belfast BT9 7AB Ireland
  • Cremona 26100 Italy
  • Meldola (FC) 47104 Italy
  • Milano 20133 Italy
  • Milano 20141 Italy
  • Modena 41124 Italy
  • Orbassano 10043 Italy
  • Padova 35128 Italy
  • Ravenna 48121 Italy
  • Roma 152 Italy
  • Trento 38122 Italy
  • Goyang-Si 410-769 Korea, Republic of
  • Hwasun-Gun 519-763 Korea, Republic of
  • Incheon 405-760 Korea, Republic of
  • Seoul 110-744 Korea, Republic of
  • Seoul 120-752 Korea, Republic of
  • Seoul 135-710 Korea, Republic of
  • Seoul 135-720 Korea, Republic of
  • Seoul 138-736 Korea, Republic of
  • Kuching Sarawak 93586 Malaysia
  • Kuala Lampur 59100 Malaysia
  • Amsterdam North Holland 1066cx Netherlands
  • Dordrecht 3318 AT Netherlands
  • Eindhoven 5623 EJ Netherlands
  • Groningen 9713 GZ Netherlands
  • Maastricht 6229 HX Netherlands
  • Christchurch 8011 New Zealand
  • Grafton 1023 New Zealand
  • Hamilton 4144 New Zealand
  • Palmerston North 4144 New Zealand
  • Tauranga 3140 New Zealand
  • Gdansk 80-952 Poland
  • Kielce 25-734 Poland
  • Lublin 20-718 Poland
  • Mielec 39-300 Poland
  • Slupsk 76-200 Poland
  • Wroclaw 51-685 Poland
  • Wroclaw 53-114 Poland
  • Wroclaw Poland
  • Wrocław 50-981 Poland
  • Moscow 115478 Russian Federation
  • Moscow 125284 Russian Federation
  • Republic of Bashkortostan Russian Federation
  • Belgrade 11000 Serbia
  • Belgrade 11040 Serbia
  • Belgrade 11080 Serbia
  • Singapore 119074 Singapore
  • Singapore 169610 Singapore
  • Martin Slovak Republic 036 01 Slovakia
  • Banska Bystrica 97517 Slovakia
  • Bratislava 85105 Slovakia
  • Kosice 4190 Slovakia
  • Nitra 94901 Slovakia
  • Presov 8001 Slovakia
  • Skalica 90980 Slovakia
  • Zilina 1207 Slovakia
  • Palma de Mallorca Baleares 07101 Spain
  • Manresa Barcelona 8243 Spain
  • Sabadell Barcelona 8208 Spain
  • San Sebastian Guipuzcoa/Pais Vasco 20014 Spain
  • Pamplona Navarra 31008 Spain
  • Barcelona 8003 Spain
  • Barcelona 8036 Spain
  • Girona 17007 Spain
  • Madrid 28006 Spain
  • Madrid 28033 Spain
  • Madrid 28041 Spain
  • Santiago 15706 Spain
  • Göteborg 41345 Sweden
  • Malmo 20502 Sweden
  • Orebro 70185 Sweden
  • Stockholm 118 53 Sweden
  • Stockholm 17176 Sweden
  • Umea 90185 Sweden
  • Chiayi County 613 Taiwan
  • Gueishan 333 Taiwan
  • Kaohsiung 80756 Taiwan
  • Kaohsiung 807 Taiwan
  • Kaohsiung 81346 Taiwan
  • Kaohsiung 81362 Taiwan
  • Kaohsiung 830 Taiwan
  • Keelung City 204 Taiwan
  • Taichung 40447 Taiwan
  • Taichung 40705 Taiwan
  • Tainan City 710 Taiwan
  • Tainan 71004 Taiwan
  • Taipei City 11217 Taiwan
  • Taipei 10002 Taiwan
  • Taipei 11217 Taiwan
  • Taipei 22060 Taiwan
  • Bangkok 10330 Thailand
  • Bangkok 10400 Thailand
  • Hat Yai 90110 Thailand
  • Muang 50200 Thailand
  • Adana 01380 Turkey
  • Ankara 06600 Turkey
  • Istanbul 34098 Turkey
  • Izmir 35110 Turkey
  • Manisa 45030 Turkey
  • Chernivtsi 58002 Ukraine
  • Dnipropetrovsk 49005 Ukraine
  • Kharkiv 61037 Ukraine
  • Kyiv 02125 Ukraine
  • Uzhgorod 88000 Ukraine
  • Zaporizhzhia 69600 Ukraine
  • Cambridge Cambridgeshire CB2 0QQ United Kingdom
  • London Greater London NW1 2BU United Kingdom
  • Manchester Greater Manchester M20 4BX United Kingdom
  • Oxford Oxfordshire OX3 7LJ United Kingdom
  • Sutton Surrey SM2 5PT United Kingdom
  • Newcastle Tyne & Wear NE7 7DN United Kingdom
  • Birmingham B15 2TH United Kingdom
  • Brighton BN2 5BE United Kingdom
  • Bristol BS2 8ED United Kingdom
  • London SW3 6JJ United Kingdom
  • London W12 0NN United Kingdom

View trial on ClinicalTrials.gov


E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe