Clinical trial NCT00676650: Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Official title: A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Keywords: Docetaxel-refractory mCRPC
Second-line treatment with sunitinib and prednisone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-13
Enrollment: 873
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
* Progressive disease based on PSA progression, RECIST, or positive bone scan.
* ECOG 0 or 1.

Exclusion Criteria:

* Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
* Chemotherapy within 3 weeks.
* Impending complications from bone metastases.
* Ongoing urinary obstruction.
* Cardiac dysfunction, QTc \>470 msec.
* CNS involvement.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline up to 32 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline, every 8 weeks up to 123 weeks
measure: Percent of Participants With Objective Response (OR)
timeFrame: Baseline, every 8 weeks up to 123 weeks
measure: Duration of Response (DR)
timeFrame: Baseline, every 8 weeks up to 123 weeks
measure: Change From Baseline in Pain Severity
timeFrame: Day 1 through Day 7 every 28 days (every cycle) up to 29 months
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: Baseline, every 4 weeks up to 123 weeks
measure: Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
timeFrame: Baseline, every 4 weeks up to 123 weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Encinitas
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Modesto
country: United States
facility: Pfizer Investigational Site
state: California
city: Thousand Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Thousands Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Westlake Village
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Arlington Heights
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Niles
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Winfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Zion
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Carmel
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fishers
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Greenfield
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Danvers
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Cloud
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Corinth
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Southaven
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Sewell
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kernersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Mount Airy
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: North Wilkesboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mentor
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Orange Village
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Westlake
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Clairton
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greensburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Kingston
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wexford
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Brighton
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Webster
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Everett
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Monroe
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Port Macquarie
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Wahroong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Wodonga
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Mons
country: Belgium
facility: Pfizer Investigational Site
city: Namur
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: BA
city: Belo Horizonte
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Caxias do Sul
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Santo André
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: WuHan
country: China
facility: Pfizer Investigational Site
state: Hubei
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Chongqing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Olomouc
country: Czech Republic
facility: Pfizer Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: Pfizer Investigational Site
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Koebenhavn Oe
country: Denmark
facility: Pfizer Investigational Site
city: Odense C
country: Denmark
facility: Pfizer Investigational Site
city: Vejle
country: Denmark
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Bordeaux Cedex
country: France
facility: Pfizer Investigational Site
city: Clermont-Ferrand Cedex 1
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 15
country: France
facility: Pfizer Investigational Site
city: Poitiers cedex
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: ROUEN Cedex
country: France
facility: Pfizer Investigational Site
city: Saint Gregoire
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Homburg/Saar
country: Germany
facility: Pfizer Investigational Site
city: Kempen
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Kfar Saba
country: Israel
facility: Pfizer Investigational Site
city: Petach Tikva
country: Israel
facility: Pfizer Investigational Site
city: Tel Hashomer
country: Israel
facility: Pfizer Investigational Site
city: Zerifin
country: Israel
facility: Pfizer Investigational Site
city: Meldola
country: Italy
facility: Pfizer Investigational Site
state: FC
city: Lido di Camaiore (LU)
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Potenza
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyunggido
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Bellavista
country: Peru
facility: Pfizer Investigational Site
state: Callao
city: Arequipa
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Kielce
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Setúbal
country: Portugal
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Prešov
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Elche
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Pamplona
country: Spain
facility: Pfizer Investigational Site
state: Navarra
city: A Coruña
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Guadalajara
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Vaxjo
country: Sweden
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
city: Bournemouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Dorset
city: Preston
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancashire
city: Northwood,
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Guildford
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
city: Swansea
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Michaelson MD, Oudard S, Ou YC, Sengelov L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullen A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.