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| Sponsored by: |
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: Provenge |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, 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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2003 |
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 73 Study Locations| Study Chair: | Paul Schellhammer, MD | Devine Tidewater Urology |
More Information
| Study ID Numbers: | D9902B |
| Study First Received: | July 23, 2003 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00065442 |
| Health Authority: | United States: Food and Drug Administration |
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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 |
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Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
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Neoplasms Neoplasms by Site |
