Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

This study has been completed.

Sponsor:

Information provided by:

Dendreon

ClinicalTrials.gov Identifier:

NCT01133704

First received: May 27, 2010

Last updated: September 2, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	May 27, 2010
Last Updated Date	September 2, 2010
Start Date ^ICMJE	May 2000
Primary Completion Date	March 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 17, 2010)	Overall Time to Disease Progression [ Time Frame: from randomization to 36 months ] [ Designated as safety issue: Yes ] Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
Original Primary Outcome Measures ^ICMJE (submitted: May 28, 2010)	Compare the overall time to disease progression [ Time Frame: from randomization to 36 month ] [ Designated as safety issue: Yes ] To compare the overall time to disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T) to those treated with the control infusion.
Change History	Complete list of historical versions of study NCT01133704 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 2, 2010)	Overall Survival [ Time Frame: Time from randomization until 36 months ] [ Designated as safety issue: Yes ] Subjects were followed for 3 years from the time of randomization or until death.
Original Secondary Outcome Measures ^ICMJE (submitted: May 28, 2010)	Overall Survival [ Time Frame: From randomization through 36 months ] [ Designated as safety issue: Yes ] To compare overall survival in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T) to those treated with the control infusion.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Official Title ^ICMJE	A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Brief Summary	This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Hormone-Refractory Prostate Cancer
Intervention ^ICMJE	Biological: sipuleucel-T Biological: APC-Placebo
Study Arm (s)	Active Comparator: sipuleucel-T (APC8015) Intervention: Biological: sipuleucel-T Placebo Comparator: Placebo Intervention: Biological: APC-Placebo
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 ^ICMJE	Completed
Enrollment ^ICMJE	98
Completion Date	May 2005
Primary Completion Date	March 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically documented adenocarcinoma of the prostate Metastatic disease as evidenced by soft tissue and/or bony metastases Prostate-specific antigen value of at least 5 ng/mL Tumor progression while on hormonal therapy Castration levels of testosterone (defined as less than 50 ng/dL) Life expectancy of at least 16 weeks Adequate hematologic, renal, and liver function Exclusion Criteria: Visceral organ metastases Metastatic disease expected to be in need of radiation therapy within 4 months. Concurrent therapy with experimental agents
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01133704
Other Study ID Numbers ^ICMJE	D9902A
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Dendreon
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dendreon
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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