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

This study is currently recruiting participants.
Verified May 2013 by Dendreon
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01306890
First received: February 28, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Advanced Prostate Cancer
Prostatic Neoplasms
 Biological: sipuleucel-T

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dendreon:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Survival [ Time Frame: Every 3 months for a minimum of 3 years ] [ Designated as safety issue: No ]
    To quantify survival in all subjects.


Estimated Enrollment: 1500
Study Start Date: January 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306890

  Show 349 Study Locations
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Candice McCoy, MD Dendreon
  More Information

No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01306890     History of Changes
Other Study ID Numbers: P10-3
Study First Received: February 28, 2011
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013