Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
0
0
A6181120
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SUN 1120
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus \[-\] date of randomization plus \[+\] 1) divided (/) 30.4.
Query!
Timepoint [1]
0
0
Baseline up to 32 months
Query!
Secondary outcome [1]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [1]
0
0
PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02
Query!
Timepoint [1]
0
0
Baseline, every 8 weeks up to 123 weeks
Query!
Secondary outcome [2]
0
0
Percent of Participants With Objective Response (OR)
Query!
Assessment method [2]
0
0
OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (\>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study \>= 4 weeks after initial documentation of response.
Query!
Timepoint [2]
0
0
Baseline, every 8 weeks up to 123 weeks
Query!
Secondary outcome [3]
0
0
Duration of Response (DR)
Query!
Assessment method [3]
0
0
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response
Query!
Timepoint [3]
0
0
Baseline, every 8 weeks up to 123 weeks
Query!
Secondary outcome [4]
0
0
Change From Baseline in Pain Severity
Query!
Assessment method [4]
0
0
Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.
Query!
Timepoint [4]
0
0
Day 1 through Day 7 every 28 days (every cycle) up to 29 months
Query!
Secondary outcome [5]
0
0
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Query!
Assessment method [5]
0
0
FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.
Query!
Timepoint [5]
0
0
Baseline, every 4 weeks up to 123 weeks
Query!
Secondary outcome [6]
0
0
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Query!
Assessment method [6]
0
0
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
Query!
Timepoint [6]
0
0
Baseline, every 4 weeks up to 123 weeks
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
873
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Pfizer Investigational Site - Port Macquarie
Query!
Recruitment hospital [2]
0
0
Pfizer Investigational Site - Wahroong
Query!
Recruitment hospital [3]
0
0
Pfizer Investigational Site - Westmead
Query!
Recruitment hospital [4]
0
0
Pfizer Investigational Site - Wodonga
Query!
Recruitment postcode(s) [1]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [2]
0
0
2076 - Wahroong
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
3690 - Wodonga
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Mississippi
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nebraska
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nevada
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Dakota
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oregon
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Tennessee
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Washington
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Wisconsin
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Bruxelles
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Liege
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Mons
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Namur
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Wilrijk
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
BA
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
MG
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
RJ
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
RS
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
SP
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
British Columbia
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Ontario
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Quebec
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Hubei
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Beijing
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Chongqing
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Shanghai
Query!
Country [42]
0
0
Czech Republic
Query!
State/province [42]
0
0
Brno
Query!
Country [43]
0
0
Czech Republic
Query!
State/province [43]
0
0
Olomouc
Query!
Country [44]
0
0
Czech Republic
Query!
State/province [44]
0
0
Usti nad Labem
Query!
Country [45]
0
0
Denmark
Query!
State/province [45]
0
0
Herlev
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Koebenhavn Oe
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Odense C
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Vejle
Query!
Country [49]
0
0
Finland
Query!
State/province [49]
0
0
Helsinki
Query!
Country [50]
0
0
Finland
Query!
State/province [50]
0
0
Tampere
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Besancon
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Bordeaux Cedex
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Clermont-Ferrand Cedex 1
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Lille
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Lyon
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Paris Cedex 15
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Poitiers cedex
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Rennes
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
ROUEN Cedex
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Saint Gregoire
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Tours
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Berlin
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Homburg/Saar
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Kempen
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Leipzig
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Muenchen
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Muenster
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Tuebingen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Ulm
Query!
Country [70]
0
0
Israel
Query!
State/province [70]
0
0
Kfar Saba
Query!
Country [71]
0
0
Israel
Query!
State/province [71]
0
0
Petach Tikva
Query!
Country [72]
0
0
Israel
Query!
State/province [72]
0
0
Tel Hashomer
Query!
Country [73]
0
0
Israel
Query!
State/province [73]
0
0
Zerifin
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
FC
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Lido di Camaiore (LU)
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Napoli
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Padova
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Pavia
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Pisa
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Potenza
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Roma
Query!
Country [82]
0
0
Korea, Republic of
Query!
State/province [82]
0
0
Gyeonggi-do
Query!
Country [83]
0
0
Korea, Republic of
Query!
State/province [83]
0
0
Gyunggido
Query!
Country [84]
0
0
Korea, Republic of
Query!
State/province [84]
0
0
Seoul
Query!
Country [85]
0
0
Peru
Query!
State/province [85]
0
0
Callao
Query!
Country [86]
0
0
Peru
Query!
State/province [86]
0
0
Arequipa
Query!
Country [87]
0
0
Peru
Query!
State/province [87]
0
0
Lima
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Gdansk
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Kielce
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Warszawa
Query!
Country [91]
0
0
Portugal
Query!
State/province [91]
0
0
Porto
Query!
Country [92]
0
0
Portugal
Query!
State/province [92]
0
0
Setúbal
Query!
Country [93]
0
0
Slovakia
Query!
State/province [93]
0
0
Bratislava
Query!
Country [94]
0
0
Slovakia
Query!
State/province [94]
0
0
Martin
Query!
Country [95]
0
0
Slovakia
Query!
State/province [95]
0
0
Prešov
Query!
Country [96]
0
0
Slovakia
Query!
State/province [96]
0
0
Zilina
Query!
Country [97]
0
0
Spain
Query!
State/province [97]
0
0
Alicante
Query!
Country [98]
0
0
Spain
Query!
State/province [98]
0
0
Barcelona
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Navarra
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
A Coruña
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Gerona
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Guadalajara
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Madrid
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Sevilla
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Valencia
Query!
Country [106]
0
0
Sweden
Query!
State/province [106]
0
0
Lund
Query!
Country [107]
0
0
Sweden
Query!
State/province [107]
0
0
Malmo
Query!
Country [108]
0
0
Sweden
Query!
State/province [108]
0
0
Stockholm
Query!
Country [109]
0
0
Sweden
Query!
State/province [109]
0
0
Vaxjo
Query!
Country [110]
0
0
Taiwan
Query!
State/province [110]
0
0
Taichung
Query!
Country [111]
0
0
Taiwan
Query!
State/province [111]
0
0
Taipei
Query!
Country [112]
0
0
Taiwan
Query!
State/province [112]
0
0
Taoyuan
Query!
Country [113]
0
0
United Kingdom
Query!
State/province [113]
0
0
Dorset
Query!
Country [114]
0
0
United Kingdom
Query!
State/province [114]
0
0
Lancashire
Query!
Country [115]
0
0
United Kingdom
Query!
State/province [115]
0
0
Middlesex
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Bristol
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Cardiff
Query!
Country [118]
0
0
United Kingdom
Query!
State/province [118]
0
0
Glasgow
Query!
Country [119]
0
0
United Kingdom
Query!
State/province [119]
0
0
Guildford
Query!
Country [120]
0
0
United Kingdom
Query!
State/province [120]
0
0
London
Query!
Country [121]
0
0
United Kingdom
Query!
State/province [121]
0
0
Sheffield
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
Swansea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00676650
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF