The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.
The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
50 mg/day orally each of Days 1-28 of each 6 week cycle
Median Progression-free Survival (PFS) Time at 1-year.
PFS is measured from the date of registration to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: 12 months
Overal Survival (OS) Rate at 1-year.
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time frame: 12 months
Prostate Specific Antigen (PSA) Response
Percentage of participants whose PSA value declined to 50% when compared to the value at the baseline.
Time frame: Baseline and up to 12 months
Change of PSA Doubling Time
Difference of PSA doubling time between baseline and end of the treatment.
Time frame: Baseline and up to 12 months
Objective Response Rate (ORR)
ORR = Complete Response (CR) + Partial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time frame: 12 months
Percentage of Participants With Decrease in Present Pain Intensity (PPI) From Baseline.
Pain score decreased \>=2 points from baseline. The PPI scale has the following descriptors: 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain, and 5=excruciating pain. The patient will be asked to self-assess and record their PPI in the study diary. Upon diary review, the study nurse will utilize the PPI daily scores to calculate the week's average. The weekly PPI score during the study is the average of the daily PPI scores, based on a minimum of 3 daily PPI assessments during a week's period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Time frame: Baseline and up to 12 months