Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy - Full Text View

Sponsor:	Dendreon
Information provided by:	Dendreon
ClinicalTrials.gov Identifier:	NCT00065442

Purpose

Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.

Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.

If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.

Condition	Intervention	Phase
Prostate Cancer	Biological: Sipuleucel-T	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Provenge Sipuleucel-T

U.S. FDA Resources

Further study details as provided by Dendreon:

Primary Outcome Measures:

To assess the safety and efficacy of Sipuleucel-T in prolonging survival of men with Metastatic Androgen Independent Prostate Cancer [ Time Frame: Overall Survival (time to death) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the safety and efficacy of Sipuleucel-T in delaying time to objective disease progression in men with Metastatic Androgen Independent Prostate Cancer [ Time Frame: Time to objective disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	July 2003
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
APC Placebo: Placebo Comparator	Biological: Sipuleucel-T A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED PHASE 3 TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (Provenge®, SIPULEUCEL-t, APC8015) in men with metastatic androgen independent prostatic adenocarcinoma
Sipuleucel-T: Active Comparator	Biological: Sipuleucel-T A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED PHASE 3 TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (Provenge®, SIPULEUCEL-t, APC8015) in men with metastatic androgen independent prostatic adenocarcinoma

Detailed Description:

The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center.

If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

To qualify for this trial, you must have ALL of the following:

Histologically documented adenocarcinoma of the prostate
Cancer that has progressed while on adequate hormone therapy. This state of the disease is androgen independent prostate cancer (AIPC).
Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone. Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you are not eligible for the study.
The absence of or minimal current cancer-related pain

Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.

Study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065442

Show 73 Study Locations

Sponsors and Collaborators

Dendreon

Investigators

Study Chair:

Paul Schellhammer, MD

Devine Tidewater Urology

More Information

Additional Information:

Prostate Cancer Research Institute This link exits the ClinicalTrials.gov site

National Prostate Cancer Coalition This link exits the ClinicalTrials.gov site

USTOO International This link exits the ClinicalTrials.gov site

American Foundation of Urological Diseases This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dendreon Corporation ( Liz Smith )
Study ID Numbers:	D9902B
Study First Received:	July 23, 2003
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00065442 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dendreon:

prostate cancer
prostate
AIPC
androgen-independent
androgen independent
hormone insensitive
hormone-insensitive
PSA
prostatic adenocarcinoma
hormone-refractory
hormone refractory
HRPC
LHRH
immune therapy

immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
therapeutic vaccine
therapeutic cancer vaccine
recombinant
biological
biopharmaceutical
biotechnology
biotech

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones

Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Adenocarcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Androgens

ClinicalTrials.gov processed this record on February 08, 2010