Brief Summary
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
Brief Title
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
Detailed Description
Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
* Subjects must be at least 18 years of age
* Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
* Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
* Subjects must understand and sign an informed consent form prior to their first leukapheresis
Exclusion Criteria:
•None
* Subjects must be at least 18 years of age
* Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
* Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
* Subjects must understand and sign an informed consent form prior to their first leukapheresis
Exclusion Criteria:
•None
Inclusion Criteria
Inclusion Criteria:
* Subjects must be at least 18 years of age
* Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
* Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
* Subjects must understand and sign an informed consent form prior to their first leukapheresis
* Subjects must be at least 18 years of age
* Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
* Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
* Subjects must understand and sign an informed consent form prior to their first leukapheresis
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
NCT01727154
Org Class
Industry
Org Full Name
Dendreon
Org Study Id
P11-4
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
Primary Outcomes
Outcome Description
The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
Outcome Measure
The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
Outcome Time Frame
Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
Start Date
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 with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of 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