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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

Phase 3
19 Years
79 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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.

Inclusion Criteria

Patients are eligible if they have:

- Histologic diagnosis of adenocarcinoma of the prostate;

- At least 3 months but no more than 8 years prior to study entry, undergone a radical
prostatectomy for stage T1b – T3c, N0-N1, M0 disease, with or without
subsequent adjuvant or salvage radiation therapy. Patients who experience their
first PSA recurrence within 2 years post completion of initial therapy of curative
intent are eligible without consideration of the Gleason score of the tumor
specimen.* Patients who experience their first PSA relapse between 2 and 8 years
post completion of initial therapy of curative intent are eligible only if the
Gleason score of the tumor specimen was > 7; (* For patients who received adjuvant
radiation, the date of the final dose of radiotherapy is used to mark the date of
completion of therapy of curative intent. For patients who received salvage
radiation for post-operative PSA recurrence but no adjuvant radiation, the date of
surgery marks the date of completion of therapy of curative intent.)

- Therapeutic PSA response to primary therapy below 0.4 ng/mL;

- Tumor specimen positive for PAP, the vaccine’s target. Immunohistological
staining of a specimen from the surgically excised tumor for expression of PAP is
conducted by IMPATH, and may be completed even after LH-RH-analogue placement, as
long as a positive (+) result is confirmed prior to randomization (Week 0). If a
slide of the tumor cannot be obtained from the pathology archive, a chart record from
a PRE-SURGERY blood sample showing serum PAP elevated above the upper limit of the
local reference range may serve as a proxy.

- Experienced PSA relapse while not currently receiving androgen ablation therapy.
Specifically, on record must be 2 PSA values separated by at least 3 months, both in
the detectable range (>0.5 ng/mL), showing an increase of at least 0.3 ng/mL between
the 2 measurements. The first of these 2 PSA values must rise above a previously
recorded post-operative nadir value (which may be an undetectable PSA). In patients
who received androgen ablation for a previous PSA relapse, PSA must have increased to
a level at least 25% above the nadir observed while on this therapy and to an
absolute level of at least 3 ng/mL;

- 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:

- post-prostatectomy PSA was never > 20 ng/mL;

- PSA was not rising while receiving adequately dosed hormonal therapy;

- for any hormonal therapy received, the last effective day of androgen
deprivation was at least 6 months prior to study entry;

- Confirmed M0; a bone scan with no evidence of osseous metastasis must be on record,
dated within 6 months prior to entry into the study;

- Estimated life-expectancy, inclusive consideration of co-morbidities, of at least 1

- ECOG performance status of 0 or 1;

- Ability to understand the trial procedures and requirements;

- Age >18 and < 80 years;

- Ability to understand, and willingness to sign, informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

time to biochemical failure

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

Related Keywords:

  • Prostate Cancer
  • cancer
  • prostate cancer
  • prostatectomy
  • PSA
  • Prostatic Neoplasms



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