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A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer

Phase 3
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer


I. Compare the time to progression, time to development of disease-related pain, and
incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic
metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus
control infusion. II. Compare response rate and duration of response in these patients.

Outline: This is a randomized study. Patients are randomized to one of two treatment arms.
Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4.
Patients receive APC8015 comprised of ADCP activated with prostatic acid
phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after
each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients
receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total
of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective
disease progression. Patients are followed monthly for up to 3 years or until disease
progression. At the time of disease progression, patients treated on arm II may receive
treatment on Protocol D9903.

Projected Accrual: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued
for this study.

Inclusion Criteria

Inclusion Criteria include:

- Metastatic disease as evidenced by soft tissue and/or bony metastases.

- Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.

- Tumor progression after hormonal therapy.

- Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for
treatment of prostate cancer. Castration levels of testosterone (< 50 ng/dL) must be
documented for all subjects including subjects who underwent orchiectomy as therapy
for cancer of the prostate.

- A subject is eligible if he initially responded to antiandrogen withdrawal (> 25%
decrease in PSA) but at the time of registration demonstrated tumor progression. A
subject is eligible if he failed to respond to antiandrogen withdrawal.

- Subjects have no cancer-related pain and do not regularly require analgesics for
cancer-related pain.

- ECOG Performance Status of 0 or 1.

- Life expectancy of at least 16 weeks.

- Adequate hematologic, renal, and liver function.

Exclusion Criteria include:

- Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive
effusions (e.g., pleural effusions or ascites).

- Metastatic disease expected to be in need of radiation therapy within 4 months.

- Concurrent therapy with experimental agents.

- Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any
reason other than treatment of prostate cancer within the previous 6 months without
prior approval.

Please note that there are additional eligibility criteria. The study center will
determine if you meet all of the criteria.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Objective Disease Progression

Outcome Description:

The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

Outcome Time Frame:

36 months from randomization

Safety Issue:


Principal Investigator

Eric J. Small, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:

D9901 CDR0000067868



Start Date:

November 1999

Completion Date:

September 2004

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Rochester Cancer Center Rochester, New York  14642
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Loma Linda University Medical Center Loma Linda, California  92354
New York Medical College Valhalla, New York  10595
St. Barnabas Medical Center Livingston, New Jersey  07039
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
Albany Regional Cancer Center Albany, New York  12208
Hackensack University Medical Center Hackensack, New Jersey  07601
Sidney Kimmel Cancer Center San Diego, California  92121
Eisenhower Medical Center Rancho Mirage, California  92270
Earle A. Chiles Research Institute at Providence Portland Medical Center Portland, Oregon  97213-2967
St. Vincents Comprehensive Cancer Center New York, New York  10011
North Penn Hospital Lansdale, Pennsylvania  19446-1200
Seattle Cancer Care Alliance Seattle, Washington  98109
Cancer and Blood Institute of the Desert Rancho Mirage, California  92270
St. Luke's-Roosevelt Hospital New York, New York  10019
Saint Mary Regional Cancer Center Langhorne, Pennsylvania  19047
Hematology/Oncology Associates of NE Pennsylvania, P.C. Scranton, Pennsylvania  18510
Office of Glenn Tisman Whittier, California  90601
Office of Barry S. Berman Orlando, Florida  32806
Center for Medical Oncology Garden City, New York  11530
AKSM Clinical Research Corporation Columbus, Ohio  43214
Abington Hematology Oncology Associates, Incorporated Abington, Pennsylvania  19001
Bryn Mawr Urology Bryn Mawr, Pennsylvania  19010
Office of Guy Bernstein, M.D. Bryn Mawr, Pennsylvania  19010
American Oncology Resources Dallas, Texas  75246
Devine Tidewater Urology Norfolk, Virginia  23507
Cancer Care Northwest Spokane, Washington  99202
Hematology Oncology Northwest, P.C. Tacoma, Washington  98405