Trial · NCT01706458
Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer
NCT01706458, Phase 2, Completed, University of Wisconsin, Madison; results first posted 2018-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer. Trials, record NCT01706458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01706458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer
- NCT number
- NCT01706458
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Prostate Cancer
- Interventions
- sipuleucel-T, DNA Vaccine
- First posted
- 2012-10-15
- Last updated
- 2021-06-18
- Results first posted
- 2018-07-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Immune Response Following Treatment | 12 months | The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen. |
| Secondary | Progression-free Survival | 12 months | Percentage of patients without radiographic progression at 12 months. |
| Secondary | Time to Radiographic Disease Progression | 12 months | Time to radiographic progression using staging obtained at month 3 as baseline for evaluation. |
| Secondary | Measure Prostate-specific Antigen (PSA) Doubling Time | 12 months | PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time "response". |
| Other | Overall Survival: Median Time to Death From Any Cause | up to approximately 5 years | Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients. |
| Other | Number of Circulating Tumor Cells | 6 months | |
| Other | PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine | 12 months | A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency\> 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline. |
| Other | Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival. | 12 months | Not performed because no progression free survival at one year. |
| Other | Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine. | 12 months | Not performed because no progression free survival at one year. |
| Other | The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively. | 12 months | Not performed because no progression free survival at one year. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Immune Response Following Treatment | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Radiographic Disease Progression | 12 months | days | MEDIAN | |
| SECONDARY | Measure Prostate-specific Antigen (PSA) Doubling Time | 12 months | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Overall Survival: Median Time to Death From Any Cause | up to approximately 5 years | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Circulating Tumor Cells | 6 months | This outcome measure was not determined because there was no progression free survival at one-year. | ||
| OTHER_PRE_SPECIFIED | PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival. | 12 months | This outcome measure was not determined because there was no progression free survival at one-year. | ||
| OTHER_PRE_SPECIFIED | Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine. | 12 months | This outcome measure was not determined because there was no progression-free survival at one-year. | ||
| OTHER_PRE_SPECIFIED | The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively. | 12 months | This outcome measure was not determined because there was no progression free survival at one-year. |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Immune Response Following Treatment | Sipuleucel-T | 6 | Participants | ||
| Number of Participants With Immune Response Following Treatment | Sipuleucel-T With DNA Vaccine | 5 | Participants | ||
| Progression-free Survival | Sipuleucel-T | 0 | Participants | ||
| Progression-free Survival | Sipuleucel-T With DNA Vaccine | 0 | Participants | ||
| Time to Radiographic Disease Progression | Sipuleucel-T | 161 | Full Range 85 to 259 | days | |
| Time to Radiographic Disease Progression | Sipuleucel-T With DNA Vaccine | 164 | Full Range 85 to 343 | days | |
| Measure Prostate-specific Antigen (PSA) Doubling Time | Sipuleucel-T | 2.5 | 95% Confidence Interval 1.1 to 8.8 | months | |
| Measure Prostate-specific Antigen (PSA) Doubling Time | Sipuleucel-T With DNA Vaccine | 2.6 | 95% Confidence Interval 1.7 to 3.6 | months | |
| Overall Survival: Median Time to Death From Any Cause | Sipuleucel-T | 32.3 | 95% Confidence Interval 7.7 to 66.7 | months | |
| Overall Survival: Median Time to Death From Any Cause | Sipuleucel-T With DNA Vaccine | 29.6 | 95% Confidence Interval 14.6 to 46.0 | months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sipuleucel-T | 9 | |
| Overall Study | STARTED | Sipuleucel-T With DNA Vaccine | 9 | |
| Overall Study | COMPLETED | Sipuleucel-T | 6 | |
| Overall Study | COMPLETED | Sipuleucel-T With DNA Vaccine | 5 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T | 3 | |
| Overall Study | NOT COMPLETED | Sipuleucel-T With DNA Vaccine | 4 |
Source ClinicalTrials.gov
Adverse events112
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 | Anemia | Blood and lymphatic system disorders | Sipuleucel-T | 0 | 9 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Sipuleucel-T With DNA Vaccine | 1 | 9 | 1 |
| other | Nausea | Gastrointestinal disorders | Sipuleucel-T | 1 | 9 | 3 |
| other | Nausea | Gastrointestinal disorders | Sipuleucel-T With DNA Vaccine | 4 | 9 | 4 |
| other | Abdominal Pain | Gastrointestinal disorders | Sipuleucel-T | 0 | 9 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Sipuleucel-T With DNA Vaccine | 1 | 9 | 1 |
| other | Constipation | Gastrointestinal disorders | Sipuleucel-T | 0 | 9 | 0 |
| other | Constipation | Gastrointestinal disorders | Sipuleucel-T With DNA Vaccine | 1 | 9 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Sipuleucel-T | 0 | 9 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Sipuleucel-T With DNA Vaccine | 1 | 9 | 3 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sipuleucel-T | 5 | 9 |
| Total, all-cause mortality | Sipuleucel-T With DNA Vaccine | 8 | 9 |
| Total, other adverse events | Sipuleucel-T | 9 | 9 |
| Total, other adverse events | Sipuleucel-T With DNA Vaccine | 9 | 9 |
| Total, serious adverse events | Sipuleucel-T | 1 | 9 |
| Total, serious adverse events | Sipuleucel-T With DNA Vaccine | 2 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29534736 | RESULT |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sipuleucel-T vs Sipuleucel-T With DNA Vaccine: Progression-free Survival | Trial comparisons |
| Sipuleucel-T vs Sipuleucel-T With DNA Vaccine: Number of Participants With Immune Response Following Treatment | Trial comparisons |
| Sipuleucel-T vs Sipuleucel-T With DNA Vaccine: deaths from any cause | Trial comparisons |
| Sipuleucel-T vs Sipuleucel-T With DNA Vaccine: serious adverse events | Trial comparisons |
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/NCT01706458
GET https://conductscience.org/api/trials/v1/NCT01706458/events?page=2