Trial · NCT00060528
Sequential Vaccinations in Prostate Cancer Patients
NCT00060528, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequential Vaccinations in Prostate Cancer Patients. Trials, record NCT00060528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00060528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequential Vaccinations in Prostate Cancer Patients
- NCT number
- NCT00060528
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Prostatic Neoplasms
- Interventions
- Recombinant Fowlpox-GM-CSF, Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM), Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM), Recombinant Human GM-CSF
- First posted
- 2003-05-07
- Last updated
- 2017-10-26
- Results first posted
- 2012-02-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Immune Response | 48 months | Immune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy. |
| Secondary | Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels | 53 months | PSA level at the time treatment is initiated compared to the PSA level at Day 85 and monthly thereafter while the patient continues on trial) |
| Secondary | Number of Participants With an Objective Response | 53 months | Objective response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria defined as: measurable disease (at least one measurable lesion), measurable lesions (lesions that can be accurately measured in at least one dimension with longest diameter \>/= 20 mm using conventional techniques or \>/= 10 mm with spiral CT scan. Non-measurable lesions (all other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan), i.e. bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion... |
| Secondary | Overall Survival | 50 months | Overall survival is defined as the date of on-study to the date of death from any cause or last follow-up. |
| Secondary | The Number of Participants With Adverse Events | 77.5 months | Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
Source ClinicalTrials.gov
Outcomes5
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 an Immune Response | 48 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels | 53 months | PSA was taken at multiple time points and proportion of patients (pts) who had a decrease in PSA of at least 30% was reported. This is standard reporting procedures for tumor markers (proportion of patients with a response);similar to RECIST reporting where there may be multiple scans obtained but one reports the proportion of pts with a response | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With an Objective Response | 53 months | All 12 participants with measurable disease were evaluated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | 50 months | Months | MEDIAN | |
| SECONDARY | The Number of Participants With Adverse Events | 77.5 months | Participants | COUNT_OF_PARTICIPANTS |
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 an Immune Response | No GM | 2 | Participants | ||
| Number of Participants With an Immune Response | Rec-hGM | 4 | Participants | ||
| Number of Participants With an Immune Response | rF-GM (10^7pfu), | 4 | Participants | ||
| Number of Participants With an Immune Response | rF-GM (10^8) | 3 | Participants | ||
| Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels | Phase 2 | 15.6 | Percentage of participants | ||
| Number of Participants With an Objective Response | Phase 2 | 0 | Participants | ||
| Overall Survival | Phase 2 | 26.6 | Full Range 6 to 50 | Months | |
| The Number of Participants With Adverse Events | Phase 2 | 32 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | no GM | 8 | |
| Overall Study | STARTED | Rec-hGM | 9 | |
| Overall Study | STARTED | rF-GM (10^7pfu) | 7 | |
| Overall Study | STARTED | rF-GM (10^8) | 8 | |
| Overall Study | COMPLETED | no GM | 8 | |
| Overall Study | COMPLETED | Rec-hGM | 9 | |
| Overall Study | COMPLETED | rF-GM (10^7pfu) | 7 | |
| Overall Study | COMPLETED | rF-GM (10^8) | 8 | |
| Overall Study | NOT COMPLETED | no GM | 0 | |
| Overall Study | NOT COMPLETED | Rec-hGM | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events420
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 rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | no GM | 4 | 8 | 5 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Rec-hGM | 0 | 9 | 0 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | rF-GM (10^7pfu) | 3 | 7 | 5 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | rF-GM (10^8) | 1 | 8 | 2 |
| other | Creatinine | Renal and urinary disorders | no GM | 3 | 8 | 7 |
| other | Creatinine | Renal and urinary disorders | Rec-hGM | 0 | 9 | 0 |
| other | Creatinine | Renal and urinary disorders | rF-GM (10^7pfu) | 0 | 7 | 0 |
| other | Creatinine | Renal and urinary disorders | rF-GM (10^8) | 0 | 8 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | no GM | 0 | 8 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | Rec-hGM | 2 | 9 | 5 |
1 to 10 of 420Source ClinicalTrials.gov
See all 420 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | no GM | 0 | 8 |
| Total, all-cause mortality | Rec-hGM | 0 | 9 |
| Total, all-cause mortality | rF-GM (10^7pfu) | 0 | 7 |
| Total, all-cause mortality | rF-GM (10^8) | 0 | 8 |
| Total, other adverse events | no GM | 8 | 8 |
| Total, other adverse events | Rec-hGM | 9 | 9 |
| Total, other adverse events | rF-GM (10^7pfu) | 7 | 7 |
| Total, other adverse events | rF-GM (10^8) | 8 | 8 |
| Total, serious adverse events | no GM | 1 | 8 |
| Total, serious adverse events | Rec-hGM | 3 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
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/NCT00060528
GET https://conductscience.org/api/trials/v1/NCT00060528/events?page=2