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NCT00005947 · CITED IN SOURCE DOCUMENTS

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2010-11-01

Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer. Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Time to Objective Disease Progression

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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.
healthy Volunteers
false
minimum Age
18 Years
sex
MALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Biological: sipuleucel-T
    label
    sipuleucel-T
    type
    ACTIVE_COMPARATOR
  2. intervention Names
    1. Biological: Placebo
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. sipuleucel-T
    description
    Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
    name
    sipuleucel-T
    other Names
    1. APC8015, Provenge
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Placebo
    description
    Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
    name
    Placebo
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
127
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
    measure
    Time to Objective Disease Progression
    time Frame
    36 months from randomization
secondary Outcomes
  1. description
    Overall Survival
    measure
    Overall Survival
    time Frame
    From randomization to 36 months
Full study description
brief Summary
Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer. Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
detailed Description
Objectives: 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.
Source references
references
  1. citation
    Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9. doi: 10.1002/cncr.24429.
    pmid
    19536890
    type
    BACKGROUND
  2. citation
    Small EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94. doi: 10.1200/JCO.2005.04.5252.
    pmid
    16809734
    type
    RESULT
  3. citation
    Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.
    pmid
    35812443
    type
    DERIVED
  4. citation
    Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.
    pmid
    24957547
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        e saved.[<a href="#cit/section_8.72">72</a>] </li></ul></div></li><li>The same investigators previously performed two smaller trials (<a href="/clinicaltrials/NCT00005947">D9901 and D9902A</a> [NCT00005947]) of nearly identical design to the IMPACT trial.[<a href="#cit/section_8.73">73</a>,<a href="#cit/section_8.74">74</a>]<div
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        ">72</a>] </li></ul></div></li><li>The same investigators previously performed two smaller trials (<a href="/clinicaltrials/NCT00005947">D9901 and D9902A</a> [NCT00005947]) of nearly identical design to the IMPACT trial.[<a href="#cit/section_8.73">73</a>,<a href="#cit/section_8.74">74</a>]<div class="pdq-content-list"><ul id="_
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      source title
      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice