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CompletedNCT00715104NeoACTUpdated May 4, 2015Results posted

Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

A Phase 2 interventional study of Sipuleucel-T with Booster and Sipuleucel-T without Booster in Prostate Cancer, sponsored by Dendreon. Completed at 7 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-04.

Sponsored by Dendreon · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Read the detailed description

This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).

02

Conditions studied

  • Prostate Cancer

Browse trials for

03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 42 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Dendreon is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Adenocarcinoma of the prostate.
  • Subject is scheduled for RP as the initial therapy for localized prostate cancer.
  • Subject is ≥ 18 years of age.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject has adequate hematologic, renal, and liver function.

Exclusion criteria

Exclusion Criteria:

  • Subject has any evidence of metastasis.
  • Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
  • Subject has received prior radiation therapy or chemotherapy for prostate cancer.
  • Subject has received systemic steroid therapy within 14 days.
  • Subject has a history of stage III or greater cancer, excluding prostate cancer.
  • Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
  • Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Sipuleucel-T with Booster

    Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, and then an additional booster infusion 13 weeks following RP.

    Biological: Sipuleucel-T with Booster

  • Experimental
    Sipuleucel-T without Booster

    Subjects were to receive 3 infusions of sipuleucel-T 12 weeks prior to RP, with no further sipuleucel-T treatment.

    Biological: Sipuleucel-T without Booster

Interventions

  • BiologicalSipuleucel-T with Booster

    Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

  • BiologicalSipuleucel-T without Booster

    Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

06

What researchers measure

Primary outcomes

  1. Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

    CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

    Time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)

Secondary outcomes

  1. Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

    CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

    Time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)

  2. Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

    CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

    Time frame: Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)

  3. Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood

    Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150-7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells.

    Time frame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)

  4. Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood

    Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.

    Time frame: Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)

  5. Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.

    The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).

    Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

  6. Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.

    The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.

    Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

  7. Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups

    The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.

    Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

  8. Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups

    The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.

    Time frame: 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP

07

Results

Posted Apr 1, 2015

Participant flow

The study was conducted across 6 sites in the US. Screening and enrollment occurred from Sept 2008 - Dec 2012. 42 subjects were registered. 41 subjects received at least 1 sipuleucel-T infusion prior to radical prostatectomr (RP),18 subjects were randomized to the booster group,15 were randomized to the no booster group; and 8 were not randomized.

Participant flow — Overall Study
MilestoneSipuleucel-T With BoosterSipuleucel-T Without BoosterSipuleucel-T Without Randomization to Booster
Started18168
Completed18168
Not completed000

Outcome measures

PrimaryChange in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

Time frame:
Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Reported as:
Mean · cells/μm2
Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
cells/μm2Biopsy Benign TissuePost-RP Benign TissuePost-RP Tumor TissuePost-RP Tumor Interface
Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject2.33 ± 0.342.03 ± 0.191.98 ± 0.186.39 ± 0.61
Statistical analysis
  • Biopsy Benign Tissue vs Post-RP Benign Tissue · Chi-squared · p = 1.000 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 16.2 · 95% CI 1.7 to 30.7
  • Biopsy Benign Tissue vs Post-RP Tumor Tissue · Chi-squared · p = 1.000 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 18.9 · 95% CI 3.5 to 34.3
  • Biopsy Benign Tissue vs Post-RP Tumor Interface · Chi-squared · p = <0.001 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 70.3 · 95% CI 52.3 to 88.3
SecondaryChange in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

CD4+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

Time frame:
Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
Reported as:
Mean · cells/μm2
Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
cells/μm2Biopsy Benign TissuePost-RP Benign TissuePost-RP Tumor TissuePost-RP Tumor Interface Tissue
Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject0.93 ± 0.240.43 ± 0.090.74 ± 0.133.83 ± 0.49
Statistical analysis
  • Biopsy Benign Tissue vs Post-RP Benign Tissue · Chi-squared · p = 1.000 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 20.6 · 95% CI 4.0 to 37.2
  • Biopsy Benign Tissue vs Post-RP Tumor Tissue · Chi-squared · p = 0.014 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 32.4 · 95% CI 13.1 to 51.6
  • Biopsy Benign Tissue vs Post-RP Tumor Interface Tissue · Chi-squared · p = <0.001 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 79.4 · 95% CI 62.8 to 96.0
SecondaryChange in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject

CD8+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.

Time frame:
Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T)
Reported as:
Mean · cells/μm2
Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
cells/μm2Biopsy Benign TissuePost-RP Benign TissuePost-RP Tumor TissuePost-RP Tumor Interface Tissue
Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject0.65 ± 0.080.94 ± 0.140.88 ± 0.122.87 ± 0.25
Statistical analysis
  • Biopsy Benign Tissue vs Post-RP Benign Tissue · Chi-squared · p = 0.002 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 35.1 · 95% CI 16.3 to 53.9
  • Biopsy Benign Tissue vs Post-RP Tumor Tissue · Chi-squared · p = 0.036 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 29.7 · 95% CI 11.7 to 47.7
  • Biopsy Benign Tissue vs Post-RP Tumor Interface Tissue · Chi-squared · p = <0.001 (Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.) · % subjects with 2-fold increase: 83.8 · 95% CI 69.3 to 98.3
SecondaryChange in Antigen PA2024-specific T Cell Immunity in Peripheral Blood

Antigen PA2024-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. This analysis was performed as previously described in Fong L et al. (J Immunol. 2001;167(12):7150-7156.). The unit of analysis is the number of IFN-γ ELISPOT counts per 300,000 peripheral blood mononuclear cells.

Time frame:
Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T)
Reported as:
Mean · numbers of spots
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood
numbers of spotsBaselinePre-RP Visit6 Weeks Post-RP12 Weeks Post-RP
Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood4.9 ± 2.456.6 ± 14.926.5 ± 9.152.3 ± 17.6
Statistical analysis
  • Baseline vs Pre-RP Visit vs 6 Weeks Post-RP vs 12 Weeks Post-RP · Mixed Models Analysis · p = <0.001 (P value is for the visit effect in the mixed model)Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.
SecondaryChange in Antigen PAP-specific T Cell Immunity in Peripheral Blood

Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase.

Time frame:
Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T)
Reported as:
Mean · numbers of spots
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood
numbers of spotsBaselinePre-RP Visit6 Weeks Post-RP12 Weeks Post-RP
Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood2.2 ± 1.713.3 ± 4.92.0 ± 1.212.8 ± 5.6
Statistical analysis
  • Baseline vs Pre-RP Visit vs 6 Weeks Post-RP vs 12 Weeks Post-RP · Mixed Models Analysis · p = 0.173 (P value is for the visit effect in the mixed model)Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.
SecondaryEffect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.

The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells).

Time frame:
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Reported as:
Mean · numbers of spots
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.
numbers of spots12 Weeks Post-RP/Pre-Booster24 Weeks Post-RP48 Weeks Post-RP72 Weeks Post-RP
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.35.6 ± 14.925.6 ± 9.723.5 ± 13.118.0 ± 5.0
Statistical analysis
  • 12 Weeks Post-RP/Pre-Booster vs 24 Weeks Post-RP · Mixed Models Analysis · p = 0.667 (P value compares 24 week post-RP to pre-booster (12 weeks post RP))
  • 12 Weeks Post-RP/Pre-Booster vs 48 Weeks Post-RP · Mixed Models Analysis · p = 0.191 (P value compares 48 week post-RP to pre-booster (12 weeks post RP))
  • 12 Weeks Post-RP/Pre-Booster vs 72 Weeks Post-RP · Mixed Models Analysis · p = 0.699 (P value compares 72 week post-RP to pre-booster (12 weeks post RP))
SecondaryEffect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.

The number of PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). PAP = Prostatic Acid Phosphatase.

Time frame:
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Reported as:
Mean · number of spots
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.
number of spots12 Weeks Post-RP/Pre-Booster24 Weeks Post-RP48 Weeks Post-RP72 Weeks Post-RP
Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.9.2 ± 5.40.3 ± 0.96.2 ± 4.80.4 ± 1.0
Statistical analysis
  • 12 Weeks Post-RP/Pre-Booster vs 24 Weeks Post-RP · Mixed Models Analysis · p = 0.086 (P value compares 24 week post-RP to pre-booster (12 weeks post RP))
  • 12 Weeks Post-RP/Pre-Booster vs 48 Weeks Post-RP · Mixed Models Analysis · p = 0.432 (P value compares 48 week post-RP to pre-booster (12 weeks post RP))
  • 12 Weeks Post-RP/Pre-Booster vs 72 Weeks Post-RP · Mixed Models Analysis · p = 0.249 (P value compares 72 week post-RP to pre-booster (12 weeks post RP))
SecondaryComparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups

The number of Antigen PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster.

Time frame:
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Reported as:
Mean · number of spots
Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups
number of spotsBooster: 12 Weeks Post-RP/Pre-BoosterNo Booster: 12 Weeks Post-RP/Pre-BoosterBooster: 24 Weeks Post-RPNo Booster: 24 Weeks Post-RPBooster: 48 Weeks Post-RPNo Booster: 48 Weeks Post-RPBooster: 72 Weeks Post-RPNo Booster: 72 Weeks Post-RP
Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups35.6 ± 14.981.7 ± 44.425.6 ± 9.722.3 ± 9.223.5 ± 13.119.5 ± 9.318.0 ± 5.012.6 ± 3.7
Statistical analysis
  • Booster: 12 Weeks Post-RP/Pre-Booster vs No Booster: 12 Weeks Post-RP/Pre-Booster vs Booster: 24 Weeks Post-RP vs No Booster: 24 Weeks Post-RP vs Booster: 48 Weeks Post-RP vs No Booster: 48 Weeks Post-RP vs Booster: 72 Weeks Post-RP vs No Booster: 72 Weeks Post-RP · Mixed Models Analysis · p = 0.950 (P value is based on the treatment effect in the mixed model)Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.
SecondaryComparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups

The number of Antigen PAP-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). The two groups were compared in the statistical model are: Randomized to Booster and Randomized to No Booster. PAP = Prostatic Acid Phosphatase.

Time frame:
12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP
Reported as:
Mean · numbers of spots
Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups
numbers of spotsBooster: 12 Weeks Post-RP/Pre-BoosterNo Booster: 12 Weeks Post-RP/Pre-BoosterBooster: 24 Weeks Post-RPNo Booster: 24 Weeks Post-RPBooster: 48 Weeks Post-RPNo Booster: 48 Weeks Post-RPBooster: 72 Weeks Post-RPNo Booster: 72 Weeks Post-RP
Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups9.2 ± 5.420.2 ± 13.90.3 ± 0.94.8 ± 1.66.2 ± 4.82.7 ± 1.70.4 ± 1.01.9 ± 1.7
Statistical analysis
  • Booster: 12 Weeks Post-RP/Pre-Booster vs No Booster: 12 Weeks Post-RP/Pre-Booster vs Booster: 24 Weeks Post-RP vs No Booster: 24 Weeks Post-RP vs Booster: 48 Weeks Post-RP vs No Booster: 48 Weeks Post-RP vs Booster: 72 Weeks Post-RP vs No Booster: 72 Weeks Post-RP · Mixed Models Analysis · p = 0.048 (P value is based on the treatment effect in the mixed model)Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sipuleucel-T With Booster—1/18 (5.6%)18/18 (100%)
Sipuleucel-T Without Booster—4/16 (25%)14/16 (87.5%)
Sipuleucel-T Without Randomization to Booster—1/8 (12.5%)8/8 (100%)
Most frequent serious events
Most frequent serious events
EventSipuleucel-T With BoosterSipuleucel-T Without BoosterSipuleucel-T Without Randomization to Booster
B-CELL LYMPHOMANeoplasms benign, malignant and unspecified (incl cysts and polyps)0/180/161/8
ARRHYTHMIACardiac disorders0/181/160/8
VISION BLURREDEye disorders0/181/160/8
INFUSION RELATED REACTIONInjury, poisoning and procedural complications0/181/160/8
DIZZINESSNervous system disorders0/181/160/8
CONFUSIONAL STATEPsychiatric disorders0/181/160/8
DISORIENTATIONPsychiatric disorders0/181/160/8
RESPIRATORY ARRESTRespiratory, thoracic and mediastinal disorders0/181/160/8
RETINAL VEIN OCCLUSIONEye disorders1/180/160/8
Most frequent other events
Showing 10 of 123
Most frequent other events
EventSipuleucel-T With BoosterSipuleucel-T Without BoosterSipuleucel-T Without Randomization to Booster
FATIGUEGeneral disorders9/188/165/8
MUSCLE SPASMSMusculoskeletal and connective tissue disorders0/183/163/8
HEADACHENervous system disorders6/184/160/8
PARAESTHESIA ORALNervous system disorders6/184/161/8
DIARRHOEAGastrointestinal disorders2/182/162/8
CITRATE TOXICITYInjury, poisoning and procedural complications2/184/162/8
ARTHRALGIAMusculoskeletal and connective tissue disorders3/184/160/8
MYALGIAMusculoskeletal and connective tissue disorders3/181/162/8
PARAESTHESIANervous system disorders1/180/162/8
NAUSEAGastrointestinal disorders4/182/161/8

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sipuleucel-T With BoosterSipuleucel-T Without BoosterSipuleucel-T Without Randomization to BoosterTotal
<=18 years0000
Between 18 and 65 years1412531
>=65 years44311
Age, Continuous
Age, Continuous(years)Sipuleucel-T With BoosterSipuleucel-T Without BoosterSipuleucel-T Without Randomization to BoosterTotal
Mean60.5 ± 5.661.4 ± 5.362.1 ± 5.761.1 ± 5.4
Sex: Female, Male
Sex: Female, Male(Participants)Sipuleucel-T With BoosterSipuleucel-T Without BoosterSipuleucel-T Without Randomization to BoosterTotal
Female0000
Male1816842
Region of Enrollment
Region of Enrollment(participants)Sipuleucel-T With BoosterSipuleucel-T Without BoosterSipuleucel-T Without Randomization to BoosterTotal
United States1816842
08

Study locations

7 sites
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • UCSF Comprehensive Cancer Center
    San Francisco, California 94115, United States
  • Kaiser Permanente Portland
    Portland, Oregon 97227, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • University of Utah School of Medicine
    Salt Lake City, Utah 84132, United States
  • Virginia Mason Medical Center
    Seattle, Washington 98101, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98102, United States
09

References and documents

Publications

  • Sheikh N, Cham J, Zhang L, DeVries T, Letarte S, Pufnock J, Hamm D, Trager J, Fong L. Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects. Cancer Res. 2016 Jul 1;76(13):3711-8. doi: 10.1158/0008-5472.CAN-15-3173. Epub 2016 May 23. PubMed 27216195 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00715104
Lead sponsor
Dendreon
Collaborators
University of California, San Francisco
Responsible party
Sponsor
First posted
Jul 15, 2008
Start date
Jul 2008
Primary completion
Dec 2012
Completion
Dec 2013
Results posted
Apr 1, 2015
Last update
May 4, 2015

Study contacts

Andy Sandler, MD
study director · Dendreon

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Prostatic Neoplasms→

Other studies from this sponsor

Dendreon

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