Brief Summary
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
Brief Title
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
Detailed Description
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Advanced Prostate Cancer
Prostatic Neoplasms
Eligibility Criteria
Inclusion Criteria:
* subjects must be at least 18 years of age
* subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment
* subjects must understand and sign an informed consent form
Exclusion Criteria:
* none
* subjects must be at least 18 years of age
* subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment
* subjects must understand and sign an informed consent form
Exclusion Criteria:
* none
Inclusion Criteria
Inclusion Criteria:
* subjects must be at least 18 years of age
* subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment
* subjects must understand and sign an informed consent form
* subjects must be at least 18 years of age
* subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment
* subjects must understand and sign an informed consent form
Gender
Male
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01306890
Org Class
Industry
Org Full Name
Dendreon
Org Study Id
P10-3
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
Primary Outcomes
Outcome Description
The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
Outcome Measure
To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
Outcome Time Frame
Every 3 months for a minimum of 3 years
Secondary Outcomes
Outcome Description
To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.
Outcome Time Frame
Every 3 months for a minimum of 3 years
Outcome Measure
Survival
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Men at least 18 years of age that have advanced prostate cancer that is treated with sipuleucel-T
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sanjay Goel
Investigator Email
sgoel@montefiore.org
Investigator Phone
718-405-8404
Categories Mesh Debug
Prostate Cancer --- PROSTATIC NEOPLASMS
Prostate Cancer --- GENITAL NEOPLASMS, MALE
Prostate Cancer --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Prostate Cancer --- PROSTATIC DISEASES
MeSH Terms
PROSTATIC NEOPLASMS
GENITAL NEOPLASMS, MALE
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
GENITAL DISEASES, MALE
GENITAL DISEASES
UROGENITAL DISEASES
PROSTATIC DISEASES
MALE UROGENITAL DISEASES
SIPULEUCEL-T