Overview

This trial is active, not recruiting.

Conditions advanced prostate cancer, prostatic neoplasms
Treatment sipuleucel-t
Sponsor Dendreon
Start date January 2011
End date January 2017
Trial size 1500 participants
Trial identifier NCT01306890, P10-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
sipuleucel-t PROVENGE, APC8015
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

Primary Outcomes

Measure
To further quantify the risk of cerebrovascular events following sipuleucel-T therapy for all subjects
time frame: Every 3 months for a minimum of 3 years

Secondary Outcomes

Measure
Survival
time frame: Every 3 months for a minimum of 3 years

Eligibility Criteria

Male participants at least 18 years old.

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:

Additional Information

Official title A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Dendreon.