Trial · NCT00108732

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

NCT00108732, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-04-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer. Trials, record NCT00108732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00108732

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
NCT number: NCT00108732
Status: Completed
Phases: Phase 2
Enrollment: 50 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Prostate Carcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
Interventions: Bicalutamide, Goserelin Acetate, Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine, Recombinant Vaccinia-TRICOM Vaccine, Sargramostim
First posted: 2005-04-19
Last updated: 2015-06-30
Results first posted: 2013-04-04

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)	Assessed at 6 months	For patients who achieved a \> 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater. Changes in PSA below 5 ng/mL will not be considered assessable for progression. For patients whose PSA has not decreased by 50%, an increase in PSA value \> 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL.
Secondary	Proportion of Patients With PSA Response	Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months	PSA response is defined as complete biochemical response or partial response. Complete Response: A PSA \< 0.2 ng/mL confirmed by a repeat PSA one month later is considered a complete biochemical response for patients with prior radical prostatectomy. A PSA \< 1 ng/mL on three separate occasions taken at least one month apart is considered a complete biochemical response in patients with radiation therapy only. Partial Response: A reduction in PSA by \> 50% from baseline, confirmed by repeat PSA 1 month later.
Secondary	Difference Between Day 4 PSA Level and Day 15 PSA Level	Assessed at day 4 and day 15 of cycle 1	PSA level was assessed on Day 4 and Day 15 of cycle 1, and a comparison between the two measurements was done.
Secondary	The Difference Between PSA Slopes Before and After Treatment	Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months	PSA slopes were assessed by multiple PSA values obtained prior to registration and during treatment. Only patients who completed at least 3 months of treatment were included in this analysis. The PSA slopes were calculated by a piecewise linear model using the three or four PSA values obtained prior to registration and PSA measurements obtained every 4 weeks for the first six months of treatment. Natural log transformed PSA levels were used in this analysis, and the difference between PSA slopes before and after treatment was calculated.

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	Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)	Assessed at 6 months	Only eligible and treated patients in step I are included in this analysis.	Proportion of patients	NUMBER
SECONDARY	Proportion of Patients With PSA Response	Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months	Only eligible and treated patients in step I are included in this analysis.	Proportion of patients	NUMBER
SECONDARY	Difference Between Day 4 PSA Level and Day 15 PSA Level	Assessed at day 4 and day 15 of cycle 1	Only 22 patients with both day 4 and day 15 PSA levels available were included in this analysis.	ng/mL	MEDIAN
SECONDARY	The Difference Between PSA Slopes Before and After Treatment	Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months	Only 31 patients who completed at least 3 months of treatment were included in this analysis.	log PSA/month	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)	Vaccinia/Fowlpox/GM-CSF	0.625	90% Confidence Interval 0.483 to 0.753	Proportion of patients
Proportion of Patients With PSA Response	Vaccinia/Fowlpox/GM-CSF	0	90% Confidence Interval 0.0 to 0.072	Proportion of patients
Difference Between Day 4 PSA Level and Day 15 PSA Level	Vaccinia/Fowlpox/GM-CSF	0.45	Full Range -1.7 to 2.4	ng/mL
The Difference Between PSA Slopes Before and After Treatment	Vaccinia/Fowlpox/GM-CSF	-0.04	Full Range -0.30 to 0.18	log PSA/month

Source ClinicalTrials.gov

Participant flow7

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Step 1 (Vaccinia/Fowlpox/GM-CSF)	STARTED	Vaccinia/Fowlpox/GM-CSF	50
Step 1 (Vaccinia/Fowlpox/GM-CSF)	Eligible and Treated	Vaccinia/Fowlpox/GM-CSF	40
Step 1 (Vaccinia/Fowlpox/GM-CSF)	COMPLETED	Vaccinia/Fowlpox/GM-CSF	36
Step 1 (Vaccinia/Fowlpox/GM-CSF)	NOT COMPLETED	Vaccinia/Fowlpox/GM-CSF	14
Step 2 (Androgen Ablation and Vaccine)	STARTED	Vaccinia/Fowlpox/GM-CSF	31
Step 2 (Androgen Ablation and Vaccine)	COMPLETED	Vaccinia/Fowlpox/GM-CSF	26
Step 2 (Androgen Ablation and Vaccine)	NOT COMPLETED	Vaccinia/Fowlpox/GM-CSF	5

Source ClinicalTrials.gov

Adverse events15

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
other	Anemia	Blood and lymphatic system disorders	Vaccinia/Fowlpox/GM-CSF	4	50
other	Fatigue	General disorders	Vaccinia/Fowlpox/GM-CSF	20	50
other	Fever w/o neutropenia	General disorders	Vaccinia/Fowlpox/GM-CSF	14	50
other	Rigors/chills	General disorders	Vaccinia/Fowlpox/GM-CSF	7	50
other	Injection site reaction	General disorders	Vaccinia/Fowlpox/GM-CSF	28	50
other	Hot flashes	Vascular disorders	Vaccinia/Fowlpox/GM-CSF	3	50
other	Anorexia	Metabolism and nutrition disorders	Vaccinia/Fowlpox/GM-CSF	3	50
other	Bilirubin increased	Investigations	Vaccinia/Fowlpox/GM-CSF	3	50
other	Hyperglycemia	Metabolism and nutrition disorders	Vaccinia/Fowlpox/GM-CSF	6	50
other	Joint pain	Musculoskeletal and connective tissue disorders	Vaccinia/Fowlpox/GM-CSF	3	50

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vaccinia/Fowlpox/GM-CSF
Total, other adverse events	Vaccinia/Fowlpox/GM-CSF	44	50
Total, serious adverse events	Vaccinia/Fowlpox/GM-CSF	2	50

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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