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Completed

NCT Number: NCT01306890

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

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.

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Key information

Conditions

Advanced Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Birmingham Hematology and Oncology Associates, LLC, Bessemer, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sipuleucel-T

Biological

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.

Other names: PROVENGE, APC8015

Primary outcomes

  1. 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

    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 outcomes

  1. Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dendreon

Industry

Registry information

Acronym: PROCEED

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 2, 2011
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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