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Trial record 1 of 1 for:    NCT01306890
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A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED)

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ClinicalTrials.gov Identifier: NCT01306890
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Advanced Prostate Cancer Prostatic Neoplasms Biological: sipuleucel-T

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 Design

Study Type : Observational
Actual Enrollment : 1973 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
Actual Study Start Date : January 27, 2011
Primary Completion Date : January 17, 2017
Study Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
sipuleucel-T Biological: sipuleucel-T
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 Name: PROVENGE, APC8015


Outcome Measures

Primary Outcome Measures :
  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 ]
    To further quantify the risk of cerebrovascular events following sipuleucel-T therapy for all subjects


Secondary Outcome Measures :
  1. Survival [ Time Frame: Every 3 months for a minimum of 3 years ]
    To quantify survival in all subjects.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men at least 18 years of age that have advanced prostate cancer that is treated with sipuleucel-T
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306890


  Show 333 Study Locations
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
More Information

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01306890     History of Changes
Other Study ID Numbers: P10-3
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases