Provenge (TM) for the Treatment of Hormone Sensitive Prostate Cancer (PROTECT)
The PROTECT-PROvenge Treatment and Early Cancer Treatment trial is a Phase IIIB trial for patients with hormone sensitive prostate cancer. The study is being conducted at over 15 participating centers throughout the US. The purpose of the study is to determine if Provenge is effective for treatment of early stage, non-metastatic prostate cancer. If you have rising PSA after radical prostatectomy, but have no evidence yet of metastasis, you may be eligible. The study compares the active vaccine to placebo (your dendritic cells that were not activated in the laboratory) to determine whether the product delays the time until the cancer progresses.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Autologous PAP-loaded Dendritic Cell Vaccine (APC8015, Provenge [TM]) in Patients With Non-metastatic Prostate Cancer Who Experience PSA Elevation Following Radical Prostatectomy: a Randomized, Controlled, Double-blind Trial|
- time to biochemical failure [ Time Frame: 0 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Biologic: Immunotherapy with PAP loaded dendritic cells.
Other Name: APC8015
Non autologous PAP loaded dendritic cells
This is a prospective, double blind, controlled, randomized trial of immunotherapy with prostatic acid phosphatase (PAP)-loaded autologous antigen presenting cells (APCs), in subjects with non metastatic prostate cancer. Subjects qualifying for this study are men who have previously undergone a prostatectomy and whose only sign of disease recurrence is a rise in serum prostate specific antigen (PSA).
The primary objectives are to compare the time to biochemical failure (BF, PSA greater than or equal to 3 ng/mL) between sipuleucel-T (treatment group) and placebo (control group), and to study the safety of sipuleucel-T. The secondary objectives are to compare time to distant failure (DF, distant metastatic disease), PSA doubling time (PSADT), and survival between the 2 treatment groups.
Following short-term open-label treatment with a luteinizing hormone-releasing hormone-analogue (LHRH-a), subjects are randomized to blinded treatment assignments of either sipuleucel-T or placebo in a 2:1 ratio. Following randomization, subjects will undergo 3 leukapheresis procedures on alternate weeks (Weeks 0, 2, and 4). Approximately three days following each leukapheresis procedure, subjects will receive an infusion of either sipuleucel-T or placebo.
Subjects will complete a checklist at specified times during the study. This checklist is designed to compare androgen suppression-related side effects during periods with and without androgen suppression. Subjects will be evaluated periodically for safety and efficacy endpoints.
At the time BF is confirmed, subjects will be eligible for a booster infusion. The booster process will consist of 1 leukapheresis procedure followed by 1 infusion of the same treatment assignment, sipuleucel-T or placebo, allocated at randomization.
Subjects will continue to be observed until DF is confirmed by bone scan or computed tomography (CT) scan, or other imaging modalities as clinically indicated. After confirmed DF, subjects will be followed for safety and survival for the remainder of their lives. The total time on study for each subject is estimated to be approximately 10 to 13 years.
|United States, California|
|Alta Bates Comprehensive Cancer Center|
|Berkeley, California, United States, 94704|
|South Orange County Medical Research|
|Laguna Hills, California, United States, 92653|
|United States, Colorado|
|University of Colorado Health Sciences Center|
|Aurora, Colorado, United States, 80045-3206|
|United States, Illinois|
|Oncology Specialists, SC|
|Park Ridge, Illinois, United States, 60068-1174|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642-0001|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|
|United States, Ohio|
|AKSM Clinical Research Group|
|Columbus, Ohio, United States, 43214|
|United States, Oregon|
|Providence Medical Center|
|Portland, Oregon, United States, 97213|
|Oregon Health and Sciences University|
|Portland, Oregon, United States, 97239|
|Oregon Urology Institute|
|Springfield, Oregon, United States, 97477|
|United States, Pennsylvania|
|Urology Health Specialists - Bryn Mawr|
|Bryn Mawr, Pennsylvania, United States, 19010|
|Albert Einstein Medical Building|
|Philadelphia, Pennsylvania, United States, 19141|
|Bryn Mawr Urology Group|
|Rosemont, Pennsylvania, United States, 19010|
|United States, Tennessee|
|University of Tennessee|
|Memphis, Tennessee, United States, 38163|
|United States, Virginia|
|Urology of Virginia, PC|
|Virginia Beach, Virginia, United States, 23462|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Swedish Medical Center|
|Seattle, Washington, United States, 98104|