GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	August 16, 2004
Last Updated Date	November 3, 2008
Start Date ^ICMJE	July 2004
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 19, 2007)	Survival [ Time Frame: 0 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 13, 2007)	Survival [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00089856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 19, 2007)	Bone pain and bone related events [ Time Frame: 0 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 13, 2007)	Bone pain and bone related events [ Designated as safety issue: No ]

Descriptive Information
Brief Title ^ICMJE	GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
Official Title ^ICMJE	A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve
Brief Summary	The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone)
Study Arms / Comparison Groups	Other: Standard of care - chemotherapy Experimental: Immunotherapy
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	626
Completion Date	October 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy Detectable metastases Any Gleason score ECOG performance status 0-2 Exclusion Criteria: Prior treatment with chemotherapy Prior Immunotherapy Prior treatment with gene therapy Significant cancer related pain
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	United States, Belgium, Canada, France, Germany, Netherlands, Sweden, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00089856
Responsible Party	Cell Genesys, Inc, Cell Genesys, Inc.
Study ID Numbers ^ICMJE	G-0029, (VITAL-1)
Study Sponsor ^ICMJE	Cell Genesys
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cell Genesys
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP