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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01306890
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Description
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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
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Study Type : Observational
Actual Enrollment : 1976 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
Actual Primary Completion Date : January 17, 2017
Actual Study Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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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
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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 ]
    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 :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:

  • none
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Dendreon
Investigators
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Study Director: Bruce Brown, MD Dendreon Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01306890    
Other Study ID Numbers: P10-3
First Posted: March 2, 2011    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: June 7, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases