A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED)

Dendreon

Status: Completed

Conditions: Prostatic Neoplasms; Advanced Prostate Cancer

Treatments: Biological: sipuleucel-T

Study type: Observational

Funder types: Industry

Identifiers

NCT01306890

P10-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,976 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,976 participants in 1 patient group

sipuleucel-T

Treatment:

Biological: sipuleucel-T