Trial · NCT00715104
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
NCT00715104, Phase 2, Completed, Dendreon; results first posted 2015-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer. Trials, record NCT00715104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00715104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer
- NCT number
- NCT00715104
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Dendreon
- Conditions
- Prostate Cancer
- Interventions
- Sipuleucel-T with Booster, Sipuleucel-T without Booster
- First posted
- 2008-07-15
- Last updated
- 2015-05-04
- Results first posted
- 2015-04-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment) | 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. |
| Secondary | 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 | Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment) | 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. |
| Secondary | 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 | Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T) | 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. |
| Secondary | Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood | Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T) | 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. |
| Secondary | Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood | Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T) | Antigen PAP-specific T cell immune response is measured using interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays. PAP = Prostatic Acid Phosphatase. |
| Secondary | Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood. | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | The number of PA2024-specific T cells was enumerated by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assays (memory T cells). |
| Secondary | Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood. | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | 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. |
| Secondary | Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | 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. |
| Secondary | Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment) | All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster. | cells/μm2 | MEAN |
| SECONDARY | 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 | Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment) | All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster | cells/μm2 | MEAN |
| SECONDARY | 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 | Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T) | All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster | cells/μm2 | MEAN |
| SECONDARY | Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood | Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T) | All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster. | numbers of spots | MEAN |
| SECONDARY | Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood | Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T) | All subjects who received at least 1 infusion of sipuleucel-T and underwent subsequent RP.~Results are not presented by arm because all assessments were performed prior to randomization to booster. | numbers of spots | MEAN |
| SECONDARY | Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood. | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis. | numbers of spots | MEAN |
| SECONDARY | Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood. | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive a booster, and had blood samples suitable for ELISPOT analysis. | number of spots | MEAN |
| SECONDARY | Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis. | number of spots | MEAN |
| SECONDARY | Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups | 12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP | Subjects received at least 1 infusion of sipuleucel-T, were randomized to receive either a booster infusion or no further treatment following RP, and had blood samples suitable for ELISPOT analysis. | numbers of spots | MEAN |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Biopsy Benign Tissue | 2.33 | Standard Error 0.34 | 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 | Post-RP Benign Tissue | 2.03 | Standard Error 0.19 | 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 | Post-RP Tumor Tissue | 1.98 | Standard Error 0.18 | 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 | Post-RP Tumor Interface | 6.39 | Standard Error 0.61 | 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 | Biopsy Benign Tissue | 0.93 | Standard Error 0.24 | 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 | Post-RP Benign Tissue | 0.43 | Standard Error 0.09 | 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 | Post-RP Tumor Tissue | 0.74 | Standard Error 0.13 | 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 | Post-RP Tumor Interface Tissue | 3.83 | Standard Error 0.49 | 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 | Biopsy Benign Tissue | 0.65 | Standard Error 0.08 | 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 | Post-RP Benign Tissue | 0.94 | Standard Error 0.14 | cells/μm2 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sipuleucel-T With Booster | 18 | |
| Overall Study | STARTED | Sipuleucel-T Without Booster | 16 | |
| Overall Study | STARTED | Sipuleucel-T Without Randomization to Booster | 8 | |
| Overall Study | COMPLETED | Sipuleucel-T With Booster | 18 | |
| Overall Study | COMPLETED | Sipuleucel-T Without Booster | 16 | |
| Overall Study | COMPLETED | Sipuleucel-T Without Randomization to Booster | 8 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T With Booster | 0 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T Without Booster | 0 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T Without Randomization to Booster | 0 |
Source ClinicalTrials.gov
Adverse events396
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Sipuleucel-T With Booster | 0 | 18 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Sipuleucel-T Without Booster | 1 | 16 | |
| other | LYMPHADENOPATHY | Blood and lymphatic system disorders | Sipuleucel-T Without Randomization to Booster | 0 | 8 | |
| other | CARDIAC FLUTTER | Cardiac disorders | Sipuleucel-T With Booster | 0 | 18 | |
| other | CARDIAC FLUTTER | Cardiac disorders | Sipuleucel-T Without Booster | 1 | 16 | |
| other | CARDIAC FLUTTER | Cardiac disorders | Sipuleucel-T Without Randomization to Booster | 0 | 8 | |
| other | PALPITATIONS | Cardiac disorders | Sipuleucel-T With Booster | 0 | 18 | |
| other | PALPITATIONS | Cardiac disorders | Sipuleucel-T Without Booster | 0 | 16 | |
| other | PALPITATIONS | Cardiac disorders | Sipuleucel-T Without Randomization to Booster | 1 | 8 | |
| other | CONJUNCTIVITIS | Eye disorders | Sipuleucel-T With Booster | 1 | 18 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T With Booster | ||
| Total, all-cause mortality | Sipuleucel-T Without Booster | ||
| Total, all-cause mortality | Sipuleucel-T Without Randomization to Booster | ||
| Total, other adverse events | Sipuleucel-T With Booster | 18 | 18 |
| Total, other adverse events | Sipuleucel-T Without Booster | 14 | 16 |
| Total, other adverse events | Sipuleucel-T Without Randomization to Booster | 8 | 8 |
| Total, serious adverse events | Sipuleucel-T With Booster | 1 | 18 |
| Total, serious adverse events | Sipuleucel-T Without Booster | 4 | 16 |
| Total, serious adverse events | Sipuleucel-T Without Randomization to Booster | 1 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27216195 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00715104
GET https://conductscience.org/api/trials/v1/NCT00715104/results?page=2