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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
0
0
A6181120
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Universal Trial Number (UTN)
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Trial acronym
SUN 1120
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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0
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Condition category
Condition code
Cancer
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0
0
0
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Prostate
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to 32 months
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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
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Timepoint [1]
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Baseline, every 8 weeks up to 123 weeks
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Secondary outcome [2]
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Percent of Participants With Objective Response (OR)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, every 8 weeks up to 123 weeks
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Secondary outcome [3]
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Duration of Response (DR)
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Assessment method [3]
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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
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Timepoint [3]
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Baseline, every 8 weeks up to 123 weeks
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Secondary outcome [4]
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Change From Baseline in Pain Severity
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Assessment method [4]
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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.
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Timepoint [4]
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Day 1 through Day 7 every 28 days (every cycle) up to 29 months
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Secondary outcome [5]
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Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, every 4 weeks up to 123 weeks
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Secondary outcome [6]
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Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, every 4 weeks up to 123 weeks
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2011
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Sample size
Target
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Accrual to date
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Final
873
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Port Macquarie
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Pfizer Investigational Site - Wahroong
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Pfizer Investigational Site - Westmead
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Pfizer Investigational Site - Wodonga
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2444 - Port Macquarie
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2076 - Wahroong
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2145 - Westmead
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3690 - Wodonga
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00676650
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00676650
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