Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

This study has been completed.

Study NCT00005947 Information provided by Dendreon

First Received on July 5, 2000. Last Updated on October 8, 2010 History of Changes

Results First Received: May 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Biological: sipuleucel-T Biological: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized between January 2000 and September 2004 across 16 clinical trial sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.

Reporting Groups

Description

Sipuleucel-T

All subjects randomized to receive sipuleucel-T.

Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.

Placebo

All subjects randomized to receive placebo.

Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Participant Flow: Overall Study

	Sipuleucel-T	Placebo
STARTED	82	45
COMPLETED	25	4
NOT COMPLETED	57	41
Death	54	40
Patient Refused to Continue	2	1
Site Closure	1	0

Baseline Characteristics

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Reporting Groups

	Description
Sipuleucel-T	All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
Placebo	All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.

Baseline Measures

	Sipuleucel-T	Placebo	Total
Number of Participants [units: participants]	82	45	127
Age [units: years] Mean ± Standard Deviation	72.1 ± 8.1	71.1 ± 8.3	71.7 ± 8.1
Age, Customized [units: Years (Min, Max)] Median ( Full Range )	73.0 ( 47 to 85 )	71.0 ( 50 to 86 )	73.0 ( 47 to 86 )
Gender [units: participants]
Female	0	0	0
Male	82	45	127

Outcome Measures

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1. Primary:

Time to Objective Disease Progression [ Time Frame: 36 months from randomization ]

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2. Secondary:

Overall Survival [ Time Frame: From randomization to 36 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A provision provides for sponsor review up to 45 days with the right to request modification based on disclosure of confidential information; extendable by 60 days to file a patent application.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Kathleen Picha
Organization: Dendreon Corporation
phone: 206-274-6762
e-mail: kpicha@dendreon.com

Publications of Results:

Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94.

Other Publications:

Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9.

Responsible Party:	Elizabeth Smith, Dendreon Corporation
ClinicalTrials.gov Identifier:	NCT00005947 History of Changes
Other Study ID Numbers:	D9901 CDR0000067868, DEN-D9901, NCI-G00-1789
Study First Received:	July 5, 2000
Results First Received:	May 28, 2010
Last Updated:	October 8, 2010
Health Authority:	United States: Food and Drug Administration