PROvenge Treatment and Early Cancer Treatment (PROTECT)
|ClinicalTrials.gov Identifier: NCT00779402|
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Control Biological: Sipuleucel-T||Phase 3|
This was 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 that qualified for this study were men who had previously undergone a prostatectomy and whose only sign of disease recurrence was a rise in serum prostate specific antigen (PSA).
The primary objectives were to compare the time to biochemical failure (BF, PSA greater than or equal to 3 ng/mL) between sipuleucel-T (treatment group) and control, and to study the safety of sipuleucel-T.
Following short-term open-label treatment with a luteinizing hormone-releasing hormone-analogue (LHRH-a), Subjects completed a checklist designed to compare androgen suppression-related side effects during periods with and without androgen suppression.
Subjects who achieved a PSA of < 1 ng/ml were randomized to blinded treatment assignments of either sipuleucel-T or control in a 2:1 ratio. Following randomization, subjects underwent 3 leukapheresis procedures on alternate weeks (Weeks 0, 2, and 4). Approximately three days following each leukapheresis procedure, subjects received an infusion of either sipuleucel-T or control.
At the time BF was confirmed, subjects were eligible for a booster infusion. The booster process consisted of 1 leukapheresis procedure followed by 1 infusion of sipuleucel-T. The booster process, in effect under protocol amendment 5, differed from the previous booster process that consisted of 1 infusion of the same treatment assigned at randomization (sipuleucel-T or control).
Subjects continued to be observed until DF was confirmed by bone scan or computed tomography (CT) scan, or other imaging modalities as clinically indicated. After confirmed DF, subjects were followed by telephone every 6 months for safety and survival, treatment-related AEs, any CVEs, or new therapies for prostate cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Autologous PAP-loaded Dendritic Cell Vaccine (Sipuleucel-T, APC8015, Provenge®) in Patients With Non-metastatic Prostate Cancer Who Experience PSA Elevation Following Radical Prostatectomy: a Randomized, Controlled, Double-blind Trial|
|Study Start Date :||October 2001|
|Primary Completion Date :||August 2006|
|Study Completion Date :||May 2015|
Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Placebo Comparator: Control
Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.
Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen.
- Time to Biochemical Failure Cumulative Incidence Percentile [ Time Frame: Every 3 months post-infusion ]Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL
- Number of Subjects That Met Biochemical Failure Status [ Time Frame: Every 3 months post-infusion ]time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779402
|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|
|Study Director:||Robert Israel, MD||Valeant Pharmaceuticals North America LLC|