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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
time to biochemical failure
No
United States: Food and Drug Administration
P-11
NCT00779402
September 2001
Name | Location |
---|---|
Mount Sinai School of Medicine | New York, New York 10029 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Rochester Medical Center | Rochester, New York 14642 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
Swedish Medical Center | Seattle, Washington 98122-4307 |
University of Colorado Health Sciences Center | Denver, Colorado 80262 |
Oncology Specialists, SC | Park Ridge, Illinois 60068 |
Oregon Health and Sciences University | Portland, Oregon |
Mckay Urology | Charlotte,, North Carolina 28204 |
Urology of Virginia, PC | Norfolk, Virginia 23507 |
University of Tennessee | Memphis, Tennessee 38163 |
Oregon Urology Institute | Springfield, Oregon 97477 |
Providence Medical Center | Portland, Oregon 97213 |
South Orange County Medical Research | Laguna Hills, California 92653 |
AKSM Clinical Research Group | Columbus, Ohio 43214 |
Urology Health Specialists - Bryn Mawr | Bryn Mawr, Pennsylvania 19010 |
Albert Einstein Medical Building | Philadelphia, Pennsylvania 19141 |
Bryn Mawr Urology Group | Rosemont, Pennsylvania 19010 |