Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)

Dendreon

Status

Terminated

Conditions

Prostate Cancer

Treatments

Biological: Sipuleucel-T

Study type

Observational

Funder types

Industry

Identifiers

NCT01727154

P11-4

Details and patient eligibility

About

The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Full 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.

Enrollment

139 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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