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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01306890
First Posted: March 2, 2011
Last Update Posted: April 24, 2017
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.
Information provided by (Responsible Party):
Dendreon
February 28, 2011
March 2, 2011
April 24, 2017
January 27, 2011
January 17, 2017   (Final data collection date for primary outcome 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 ]
To further quantify the risk of cerebrovascular events following sipuleucel-T therapy for all subjects
Same as current
Complete list of historical versions of study NCT01306890 on ClinicalTrials.gov Archive Site
Survival [ Time Frame: Every 3 months for a minimum of 3 years ]
To quantify survival in all subjects.
Same as current
Not Provided
Not Provided
 
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Men at least 18 years of age that have advanced prostate cancer that is treated with sipuleucel-T
  • Advanced Prostate Cancer
  • Prostatic Neoplasms
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
sipuleucel-T
Intervention: Biological: sipuleucel-T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1973
January 17, 2017
January 17, 2017   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01306890
P10-3
No
Not Provided
Not Provided
Dendreon
Dendreon
Not Provided
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
Dendreon
April 2017