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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01306890
First received: February 28, 2011
Last updated: February 12, 2014
Last verified: January 2014

February 28, 2011
February 12, 2014
January 2011
December 2015   (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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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.
 
Active, not recruiting
1500
Not Provided
December 2015   (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:

  • none
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01306890
P10-3
No
Dendreon
Dendreon
Not Provided
Study Director: Candice McCoy, MD Dendreon
Dendreon
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP