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Sponsored by: |
Dendreon |
---|---|
Information provided by: | Dendreon |
ClinicalTrials.gov Identifier: | NCT00779402 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Other: Placebo Biological: Provenge |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
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 |
Estimated Enrollment: | 159 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | December 2003 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Provenge
|
Biological: Provenge
Biologic: Immunotherapy with PAP loaded dendritic cells.
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2
Placebo
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Other: Placebo
Non autologous PAP loaded dendritic cells
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This is a prospective, double-blind, controlled, randomized trial of immunotherapy with autologous PAP-loaded dendritic cells (Provenge™) in patients with non-metastatic prostate cancer. Patients 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 efficacy endpoint is serologic (PSA) progression. The secondary endpoint is time-to progression (i.e. androgen-independent progression, distant failure, local recurrence). Data from this study will be combined with data from a similar study to provide greater statistical power to detect a difference in the secondary efficacy endpoint. An interim analysis is planned for safety parameters only.
The treatment schema is presented in Figure 1. Following short-term open-label treatment with a LH-RH (luteinizing hormone-releasing hormone)-analogue, patients are randomized to blinded treatment assignments of either the Active Vaccine or Control Vaccine Group in a 2:1 ratio. Patients undergo three leukaphereses on alternate weeks (Weeks 0, 2 and 4 post randomization). Leukapheresis material is shipped to regional cell-processing centers for generating PAP-loaded dendritic cells. Two days following leukapheresis, patients receive an infusion with either Provenge™ or control infusion.
Patients complete an elicited symptom log at specified times during the study aimed to compare androgen suppression-related side effects during periods with and without androgen suppression. Patients are evaluated periodically for safety and efficacy endpoints.
Median time from randomization to serologic progression (PSA rise to > 3 ng/mL) is reported from similar patient series in the literature as 11.6 months (range 3-24 months). At the time patients develop serologic progression they are eligible for one booster vaccination with cell product, and continue to be observed until PSA exceeds a threshold value as specified in Section 6.3.1. Once this PSA threshold value is reached, patients are retreated with androgen ablation. Bone scans are repeated every other year unless clinically indicated earlier; serum PSA and testosterone are monitored quarterly by a central lab until the patient completes the study or withdraws.
Approximately 159 patients will be accrued in 10-15 urologic/oncology care institutions in the United States. The anticipated patient accrual period is 18 months.
Ages Eligible for Study: | 19 Years to 79 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Patients are eligible if they have:
Prior hormone treatment for an earlier episode of PSA relapse is neither an exclusion nor an inclusion requirement for study entry. Patients who have previously been treated with adjuvant or salvage radiation following radical prostatectomy, or with either LH-RH-analogue (i.e., leuprolide or goserelin acetate) or non-steroidal anti-androgen therapy (i.e., bicalutamide 150 mg/day) for a prior PSA relapse, may enter the study provided:
United States, California | |
Alta Bates Comprehensive Cancer Center | |
Berkeley, California, United States, 94704 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80220-3206 | |
United States, Illinois | |
Oncology Specialists, SC | |
Park Ridge, Illinois, United States, 60068-1174 | |
United States, Massachusetts | |
Lahey Clinic - Department of Urology | |
Burlington, Massachusetts, United States, 01805 | |
United States, New York | |
University of Rochester Medical Center | |
Rochester, New York, United States, 14642-0001 | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
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, 97201-3098 | |
Providence Medical Center | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
David T. Harris, Office of | |
Wynnewood, Pennsylvania, United States, 19096 | |
Guy T. Bernstein, Office of | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
Bryn Mawr Urology | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
Albert Einstein Medical Building | |
Philadelphia, Pennsylvania, United States, 19141 | |
United States, Tennessee | |
University of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
United States, Virginia | |
Devine Tidewater Urology | |
Norfolk, Virginia, United States, 23507 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 | |
Swedish Medical Center | |
Seattle, Washington, United States, 98104 |
Responsible Party: | Dendreon Corporation ( Sponsor ) |
Study ID Numbers: | P-11 |
Study First Received: | October 22, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00779402 |
Health Authority: | United States: Food and Drug Administration |
cancer prostate cancer prostatectomy PSA |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |