Trial · NCT00849121
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
NCT00849121, Phase 2, Completed, University of Wisconsin, Madison; results first posted 2014-09-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer. Trials, record NCT00849121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00849121
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
- NCT number
- NCT00849121
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Prostate Cancer
- Interventions
- pTVG-HP with rhGM-CSF, pTVG-HP with rhGM-CSF
- First posted
- 2009-02-23
- Last updated
- 2019-11-21
- Results first posted
- 2014-09-11
- Limitations and caveats
- Of the 17 participants enrolled, 16 received at least 6 initial immunizations with pTVG-HP vaccine and were deemed evaluable to be assessed for outcome measure 3.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. | From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years | The number and severity of toxicity incidents occurring between the pre-treatment and the final off-study evaluation will be collected and assigned an attribution. The toxicities observed will be summarized in terms of types and severities by the NCI Common Terminology Criteria version 3 for each study arm. The number of subjects experiencing grade 2 or higher autoimmune events or grade 3 or higher toxicities felt to be at least possibly related to pTVG-HP with GM-CSF study treatment will be compared between the two arms. |
| Primary | Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline. | Baseline and 1 year. | The number of patients with a T-cell immune response will be determined for each study arm. An immune response will be defined as a PAP-specific T-cell frequency or proliferation index at 1 year that is at least 3-fold higher than the baseline T-cell frequency or proliferation index. |
| Secondary | The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period. | Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years | The number of subjects who experience at least a two-fold increase in the PSA doubling time will be documented for each study arm. The PSA doubling time will be calculated using all PSA values obtained starting on Treatment Day 0 and continuing to end of treatment period and compared to the PSA doubling time collected at study entry prior to beginning study treatment. |
| Secondary | The Number of Participants Who Are Metastasis-free at One Year. | one year from study entry | The number of subjects who are metastatic-free at one year after starting study treatment will be tabulated for each arm. CT Scans and Bone Scans will be obtained at one year to determine whether metastatic disease is present. |
Source ClinicalTrials.gov
Outcomes4
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 > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. | From the time the patient begins treatment until 30 days after the last treatment with pTVG-HP vaccine, up to a maximum of 2 years | participants | NUMBER | |
| PRIMARY | Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline. | Baseline and 1 year. | participants | NUMBER | |
| SECONDARY | The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period. | Starting at Treatment Day 0 and continuing every 4-6 weeks until end of treatment period, an average of 2 years | participants | NUMBER | |
| SECONDARY | The Number of Participants Who Are Metastasis-free at One Year. | one year from study entry | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
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 > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 1 | participants | ||
| Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 0 | participants | ||
| Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline. | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 3 | participants | ||
| Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline. | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 6 | participants | ||
| The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period. | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 3 | participants | ||
| The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period. | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 4 | participants | ||
| The Number of Participants Who Are Metastasis-free at One Year. | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 6 | participants | ||
| The Number of Participants Who Are Metastasis-free at One Year. | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 6 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 8 | |
| Overall Study | STARTED | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 9 | |
| Overall Study | COMPLETED | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 8 | |
| Overall Study | COMPLETED | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 9 | |
| Overall Study | NOT COMPLETED | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 0 | |
| Overall Study | NOT COMPLETED | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 0 |
Source ClinicalTrials.gov
Adverse events86
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 | Allergic reaction | Immune system disorders | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 1 | 8 | 1 |
| other | Allergic reaction | Immune system disorders | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 2 | 9 | 2 |
| other | Hypertension | Cardiac disorders | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 1 | 8 | 2 |
| other | Hypertension | Cardiac disorders | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 0 | 9 | 0 |
| other | Fatigue | General disorders | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 3 | 8 | 3 |
| other | Fatigue | General disorders | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 2 | 9 | 2 |
| other | Chills | General disorders | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 3 | 8 | 4 |
| other | Chills | General disorders | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 0 | 9 | 0 |
| other | Fever without neutropenia | General disorders | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 1 | 8 | 1 |
| other | Fever without neutropenia | General disorders | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 1 | 9 | 1 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | ||
| Total, all-cause mortality | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | ||
| Total, other adverse events | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 8 | 8 |
| Total, other adverse events | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 9 | 9 |
| Total, serious adverse events | 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 | 3 | 8 |
| Total, serious adverse events | 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12 | 1 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39208856 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 vs 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12: The Number of Participants Who Experience at Least a Two-fold Increase in the PSA Doubling Time During the Treatment Period. | Trial comparisons |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 vs 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12: Number of Participants Who Experience at Least a 3-fold Higher PAP-specific T-cell Frequency or Proliferation Index at One Year Compared to Baseline. | Trial comparisons |
| 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 vs 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12: The Number of Participants Who Are Metastasis-free at One Year. | Trial comparisons |
1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 vs 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12: Number of Participants With > = Grade 2 Autoimmune Events or >=Toxicities at Least Possibly Related to pTVG-HP With GM-CSF Study Treatment. | Trial comparisons |
| 1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12 vs 2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12: 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/NCT00849121
GET https://conductscience.org/api/trials/v1/NCT00849121/events?page=2