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

Completed

• Conditions: Advanced Prostate Cancer; Prostatic Neoplasms
• Interventions: Biological: sipuleucel-T

• Registration Number: NCT01306890
• Lead Sponsor: Dendreon

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.

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.

Study Timeline

• Study Start: 2011-01-27
• Study First Submitted: 2011-02-28
• Study First Submitted QC: 2011-02-28
• Study First Posted: 2011-03-02
• Primary Completion: 2017-01-17
• Study Completion: 2017-01-17
• Results First Submitted: 2018-01-31
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Results First Posted: 2019-06-07
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1976

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sipuleucel-T	sipuleucel-T	-

Primary Outcome Measures

Name	Time	Method
To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects	Every 3 months for a minimum of 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Survival	Every 3 months for a minimum of 3 years	To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.

Trial Locations

Locations (250)

Birmingham Hematology and Oncology Associates, LLC; 🇺🇸 Birmingham, Alabama, United States

Clearview Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

Ironwood Cancer and Research; 🇺🇸 Chandler, Arizona, United States

Palo Verde Cancer Specialists; 🇺🇸 Glendale, Arizona, United States

Weatern Regional Medical Center / Cancer Treatment Centers of America; 🇺🇸 Goodyear, Arizona, United States

21st Century Oncology; 🇺🇸 Naples, Florida, United States

Pinnacle Oncology Hematology, Oncology Research Associates, PLLC; 🇺🇸 Scottsdale, Arizona, United States

Arizona Oncology Associates, PC - HOPE; 🇺🇸 Tucson, Arizona, United States

El Dorado Research; 🇺🇸 Tucson, Arizona, United States

Urological Associates of Southern Arizona, P.C.; 🇺🇸 Tucson, Arizona, United States

Scroll for more (240 remaining)