Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065442
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2003-07-23
Brief Title:
Provenge Sipuleucel-T Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Sponsor:
Dendreon
Organization:
Dendreon
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 ProvengeR APC8015 in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Provenge is an investigational product designed to activate a mans 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
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
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
If you qualify for and decide to participate in the trial you will have three product administrations over the course of one month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None