Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00676650




Registration number
NCT00676650
Ethics application status
Date submitted
8/05/2008
Date registered
13/05/2008
Date last updated
8/03/2013

Titles & IDs
Public title
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy
Scientific 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
Secondary ID [1] 0 0
A6181120
Universal Trial Number (UTN)
Trial acronym
SUN 1120
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Prednisone
Treatment: Drugs - sunitinib
Treatment: Drugs - Placebo
Treatment: Drugs - Prednisone

Experimental: A - Treatment Arm A - sunitinib + prednisone

Placebo comparator: B - Treatment Arm B - placebo + prednisone


Treatment: Drugs: Prednisone
5 mg BID, oral

Treatment: Drugs: sunitinib
37.5 mg/day, oral, administered on a continuous daily dosing regimen

Treatment: Drugs: Placebo
37.5 mg/day, oral, administered on a continuous daily dosing regimen

Treatment: Drugs: Prednisone
5 mg BID, oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Baseline up to 32 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [2] 0 0
Percent of Participants With Objective Response (OR)
Timepoint [2] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [3] 0 0
Duration of Response (DR)
Timepoint [3] 0 0
Baseline, every 8 weeks up to 123 weeks
Secondary outcome [4] 0 0
Change From Baseline in Pain Severity
Timepoint [4] 0 0
Day 1 through Day 7 every 28 days (every cycle) up to 29 months
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Timepoint [5] 0 0
Baseline, every 4 weeks up to 123 weeks
Secondary outcome [6] 0 0
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Timepoint [6] 0 0
Baseline, every 4 weeks up to 123 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
873
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Port Macquarie
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Wahroong
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Wodonga
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2076 - Wahroong
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
North Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Belgium
State/province [25] 0 0
Bruxelles
Country [26] 0 0
Belgium
State/province [26] 0 0
Liege
Country [27] 0 0
Belgium
State/province [27] 0 0
Mons
Country [28] 0 0
Belgium
State/province [28] 0 0
Namur
Country [29] 0 0
Belgium
State/province [29] 0 0
Wilrijk
Country [30] 0 0
Brazil
State/province [30] 0 0
BA
Country [31] 0 0
Brazil
State/province [31] 0 0
MG
Country [32] 0 0
Brazil
State/province [32] 0 0
RJ
Country [33] 0 0
Brazil
State/province [33] 0 0
RS
Country [34] 0 0
Brazil
State/province [34] 0 0
SP
Country [35] 0 0
Canada
State/province [35] 0 0
British Columbia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
China
State/province [38] 0 0
Hubei
Country [39] 0 0
China
State/province [39] 0 0
Beijing
Country [40] 0 0
China
State/province [40] 0 0
Chongqing
Country [41] 0 0
China
State/province [41] 0 0
Shanghai
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Brno
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Olomouc
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Usti nad Labem
Country [45] 0 0
Denmark
State/province [45] 0 0
Herlev
Country [46] 0 0
Denmark
State/province [46] 0 0
Koebenhavn Oe
Country [47] 0 0
Denmark
State/province [47] 0 0
Odense C
Country [48] 0 0
Denmark
State/province [48] 0 0
Vejle
Country [49] 0 0
Finland
State/province [49] 0 0
Helsinki
Country [50] 0 0
Finland
State/province [50] 0 0
Tampere
Country [51] 0 0
France
State/province [51] 0 0
Besancon
Country [52] 0 0
France
State/province [52] 0 0
Bordeaux Cedex
Country [53] 0 0
France
State/province [53] 0 0
Clermont-Ferrand Cedex 1
Country [54] 0 0
France
State/province [54] 0 0
Lille
Country [55] 0 0
France
State/province [55] 0 0
Lyon
Country [56] 0 0
France
State/province [56] 0 0
Paris Cedex 15
Country [57] 0 0
France
State/province [57] 0 0
Poitiers cedex
Country [58] 0 0
France
State/province [58] 0 0
Rennes
Country [59] 0 0
France
State/province [59] 0 0
ROUEN Cedex
Country [60] 0 0
France
State/province [60] 0 0
Saint Gregoire
Country [61] 0 0
France
State/province [61] 0 0
Tours
Country [62] 0 0
Germany
State/province [62] 0 0
Berlin
Country [63] 0 0
Germany
State/province [63] 0 0
Homburg/Saar
Country [64] 0 0
Germany
State/province [64] 0 0
Kempen
Country [65] 0 0
Germany
State/province [65] 0 0
Leipzig
Country [66] 0 0
Germany
State/province [66] 0 0
Muenchen
Country [67] 0 0
Germany
State/province [67] 0 0
Muenster
Country [68] 0 0
Germany
State/province [68] 0 0
Tuebingen
Country [69] 0 0
Germany
State/province [69] 0 0
Ulm
Country [70] 0 0
Israel
State/province [70] 0 0
Kfar Saba
Country [71] 0 0
Israel
State/province [71] 0 0
Petach Tikva
Country [72] 0 0
Israel
State/province [72] 0 0
Tel Hashomer
Country [73] 0 0
Israel
State/province [73] 0 0
Zerifin
Country [74] 0 0
Italy
State/province [74] 0 0
FC
Country [75] 0 0
Italy
State/province [75] 0 0
Lido di Camaiore (LU)
Country [76] 0 0
Italy
State/province [76] 0 0
Napoli
Country [77] 0 0
Italy
State/province [77] 0 0
Padova
Country [78] 0 0
Italy
State/province [78] 0 0
Pavia
Country [79] 0 0
Italy
State/province [79] 0 0
Pisa
Country [80] 0 0
Italy
State/province [80] 0 0
Potenza
Country [81] 0 0
Italy
State/province [81] 0 0
Roma
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Gyeonggi-do
Country [83] 0 0
Korea, Republic of
State/province [83] 0 0
Gyunggido
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul
Country [85] 0 0
Peru
State/province [85] 0 0
Callao
Country [86] 0 0
Peru
State/province [86] 0 0
Arequipa
Country [87] 0 0
Peru
State/province [87] 0 0
Lima
Country [88] 0 0
Poland
State/province [88] 0 0
Gdansk
Country [89] 0 0
Poland
State/province [89] 0 0
Kielce
Country [90] 0 0
Poland
State/province [90] 0 0
Warszawa
Country [91] 0 0
Portugal
State/province [91] 0 0
Porto
Country [92] 0 0
Portugal
State/province [92] 0 0
Setúbal
Country [93] 0 0
Slovakia
State/province [93] 0 0
Bratislava
Country [94] 0 0
Slovakia
State/province [94] 0 0
Martin
Country [95] 0 0
Slovakia
State/province [95] 0 0
Prešov
Country [96] 0 0
Slovakia
State/province [96] 0 0
Zilina
Country [97] 0 0
Spain
State/province [97] 0 0
Alicante
Country [98] 0 0
Spain
State/province [98] 0 0
Barcelona
Country [99] 0 0
Spain
State/province [99] 0 0
Navarra
Country [100] 0 0
Spain
State/province [100] 0 0
A Coruña
Country [101] 0 0
Spain
State/province [101] 0 0
Gerona
Country [102] 0 0
Spain
State/province [102] 0 0
Guadalajara
Country [103] 0 0
Spain
State/province [103] 0 0
Madrid
Country [104] 0 0
Spain
State/province [104] 0 0
Sevilla
Country [105] 0 0
Spain
State/province [105] 0 0
Valencia
Country [106] 0 0
Sweden
State/province [106] 0 0
Lund
Country [107] 0 0
Sweden
State/province [107] 0 0
Malmo
Country [108] 0 0
Sweden
State/province [108] 0 0
Stockholm
Country [109] 0 0
Sweden
State/province [109] 0 0
Vaxjo
Country [110] 0 0
Taiwan
State/province [110] 0 0
Taichung
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taipei
Country [112] 0 0
Taiwan
State/province [112] 0 0
Taoyuan
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Dorset
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Lancashire
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Middlesex
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Bristol
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Cardiff
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Glasgow
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Guildford
Country [120] 0 0
United Kingdom
State/province [120] 0 0
London
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Sheffield
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00676650