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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

Tracking Information
First Submitted Date February 28, 2011
First Posted Date March 2, 2011
Results First Submitted Date January 31, 2018
Results First Posted Date June 7, 2019
Last Update Posted Date June 7, 2019
Actual Study Start Date January 27, 2011
Actual Primary Completion Date January 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2019)
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.
Original Primary Outcome Measures
 (submitted: February 28, 2011)
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
Change History
Current Secondary Outcome Measures
 (submitted: March 5, 2019)
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.
Original Secondary Outcome Measures
 (submitted: February 28, 2011)
Survival [ Time Frame: Every 3 months for a minimum of 3 years ]
To quantify survival in all subjects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
Official Title A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Advanced Prostate Cancer
  • Prostatic Neoplasms
Intervention 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
Study Groups/Cohorts sipuleucel-T
Intervention: Biological: sipuleucel-T
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 5, 2019)
1976
Original Estimated Enrollment
 (submitted: February 28, 2011)
1500
Actual Study Completion Date January 17, 2017
Actual Primary Completion Date January 17, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01306890
Other Study ID Numbers P10-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dendreon
Study Sponsor Dendreon
Collaborators Not Provided
Investigators
Study Director: Bruce Brown, MD Dendreon Pharmaceuticals
PRS Account Dendreon
Verification Date March 2019