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| 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 Biological: APC-Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 512 |
| Study Start Date: | July 2003 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: APC-Placebo |
Biological: APC-Placebo
Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
|
| Active Comparator: Sipuleucel-T |
Biological: Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
|
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 |
To qualify for this trial, you must have ALL of the following:
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
Show 71 Study Locations| Study Chair: | Paul Schellhammer, MD | Devine Tidewater Urology |
More Information
| Responsible Party: | Liz Smith, Dendreon Corporation |
| ClinicalTrials.gov Identifier: | NCT00065442 History of Changes |
| Obsolete Identifiers: | NCT00084760 |
| Other Study ID Numbers: | D9902B |
| Study First Received: | July 23, 2003 |
| Results First Received: | May 28, 2010 |
| Last Updated: | September 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
