Trial · NCT00450463

Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer

NCT00450463, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2018-11-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer. Trials, record NCT00450463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00450463

On this page

Trial

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

Title: Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer
NCT number: NCT00450463
Status: Completed
Phases: Phase 2
Enrollment: 64 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Prostate Cancer
Interventions: Sargramostim (GM-CSF, Leukine), Flutamide (Eulexin), PROSTVAC-F/ TRICOM, PROSTVAC-V/TRICOM
First posted: 2007-03-22
Last updated: 2018-11-29
Results first posted: 2018-11-26
Limitations and caveats: Eleven patient cross-over group have no statistical plan in the protocol for analysis, highlighting their exploratory nature.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Time to Treatment Failure	Median Potential Follow-up of 46.7 months	Time to treatment failure is defined as a rising Prostatic Specific Antigen (PSA) (Bubley criteria, JCO 1999), development of metastatic disease, or removal from treatment due to excessive toxicity) compared to patients receiving flutamide alone. Normal PSA is 4.0 ng/mL or lower.
Secondary	Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	Median Potential Follow-up of 46.7 months	Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Secondary	Number of Participants With Prostatic Specific Antigen (PSA) Response	Median potential follow-up for all patients is 46.7 months	Complete response is PSA \<0.2 confirmed by a second reading at least 4 weeks later. All patients with a PSA decline of \>50% (confirmed by a second value at least 4 weeks after the first) and who have no other evidence of disease progression will be reported with both PSA decline only and PSA decline and stable disease on scans. A 25% increase in PSA over nadir is progressive disease with or without evidence of metastatic disease, and/or development of disease on scans or a second occurrence of rising PSA levels in the absence of clinical progression.
Secondary	Percentage of Participants With Antigen Specific Immune Responses Against Prostatic Specific Antigen (PSA)	3 months	Antigen specific responses were evaluated using intracellular cytokine staining of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) cells (evaluating cluster of Differentiation 107a (CD107a), INFg, Interleukin-2 (IL-2), and tumor necrosis factor (TNF) for CD4+ and CD8+ T-cells. Peripheral blood mononuclear cells were separated by Ficoll-Hypaque density gradient separation, washed three times, and preserved in 90% heat-inactivated human A and B blood-type antigens) AB serum and 10% Dimethyl sulfoxide (DMSO) in liquid nitrogen at a concentration of 1 × 10\^7 cells/mL until assayed. Analysis of antigen-specific responses following therapy was assessed by intracellular cytokine staining following a period of in vitro stimulation with overlapping 15-mer peptide pools. A more complete description can be found at Heery CR et al, Cancer Immunol Res. 2015 Nov;3(11):1248-56.

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	Time to Treatment Failure	Median Potential Follow-up of 46.7 months	Although patients without radiographic progression were allowed to get vaccine after progression on flutamide, the primary comparison in the two groups of this study was Flutamide alone vs. Fluatmiade + vaccine simultaneously. Thus the data on TTF presented is for progression on flutamide alone.	Months	MEDIAN
SECONDARY	Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	Median Potential Follow-up of 46.7 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Prostatic Specific Antigen (PSA) Response	Median potential follow-up for all patients is 46.7 months	Although patients without radiographic progression were allowed to get vaccine after progression on flutamide, the primary comparison in the two groups of this study was Flutamide alone vs. Fluatmiade + vaccine simultaneously.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants With Antigen Specific Immune Responses Against Prostatic Specific Antigen (PSA)	3 months		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
Time to Treatment Failure	Flutamide Alone	4.5	Full Range 2 to 70	Months
Time to Treatment Failure	Flutamide + Vaccine + Sargramostim	6.9	Full Range 2.5 to 40	Months
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	Flutamide Alone	33		Participants
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	Flutamide + Vaccine + Sargramostim	31		Participants
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)	Vaccine Alone After Flutamide	11		Participants
Number of Participants With Prostatic Specific Antigen (PSA) Response	Flutamide Alone	7		Participants
Number of Participants With Prostatic Specific Antigen (PSA) Response	Flutamide + Vaccine + Sargramostim	7		Participants
Percentage of Participants With Antigen Specific Immune Responses Against Prostatic Specific Antigen (PSA)	Flutamide Alone	58		percentage of participants
Percentage of Participants With Antigen Specific Immune Responses Against Prostatic Specific Antigen (PSA)	Flutamide + Vaccine + Sargramostim	56		percentage of participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Initial Drug Administration	STARTED	Flutamide Alone	33
Initial Drug Administration	STARTED	Flutamide + Vaccine + Sargramostim	31
Initial Drug Administration	COMPLETED	Flutamide Alone	33
Initial Drug Administration	COMPLETED	Flutamide + Vaccine + Sargramostim	31
Initial Drug Administration	NOT COMPLETED	Flutamide Alone	0
Initial Drug Administration	NOT COMPLETED	Flutamide + Vaccine + Sargramostim	0
Progressed to Receive Vaccine Alone	STARTED	Flutamide Alone	11
Progressed to Receive Vaccine Alone	STARTED	Flutamide + Vaccine + Sargramostim	0
Progressed to Receive Vaccine Alone	COMPLETED	Flutamide Alone	11
Progressed to Receive Vaccine Alone	COMPLETED	Flutamide + Vaccine + Sargramostim	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events486

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	Abdominal distension	Gastrointestinal disorders	Flutamide Alone	1	33	1
other	Abdominal distension	Gastrointestinal disorders	Flutamide + Vaccine + Sargramostim	0	31	0
other	Abdominal distension	Gastrointestinal disorders	Vaccine Alone After Flutamide	0	11	0
other	Alanine aminotransferase increased	Investigations	Flutamide Alone	10	33	17
other	Alanine aminotransferase increased	Investigations	Flutamide + Vaccine + Sargramostim	14	31	26
other	Alanine aminotransferase increased	Investigations	Vaccine Alone After Flutamide	0	11	0
other	Alkaline phosphatase increased	Investigations	Flutamide Alone	2	33	2
other	Alkaline phosphatase increased	Investigations	Flutamide + Vaccine + Sargramostim	2	31	5
other	Alkaline phosphatase increased	Investigations	Vaccine Alone After Flutamide	1	11	1
other	Allergic reaction	Immune system disorders	Flutamide Alone	1	33	1

1 to 10 of 486Source ClinicalTrials.gov

See all 486 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Flutamide Alone	0	33
Total, all-cause mortality	Flutamide + Vaccine + Sargramostim	0	31
Total, all-cause mortality	Vaccine Alone After Flutamide	0	11
Total, other adverse events	Flutamide Alone	32	33
Total, other adverse events	Flutamide + Vaccine + Sargramostim	29	31
Total, other adverse events	Vaccine Alone After Flutamide	11	11
Total, serious adverse events	Flutamide Alone	4	33
Total, serious adverse events	Flutamide + Vaccine + Sargramostim	5	31
Total, serious adverse events	Vaccine Alone After Flutamide	0	11

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
9218025	BACKGROUND	PubMed
10655437	BACKGROUND	PubMed
15661684	BACKGROUND	PubMed
37134294	DERIVED	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Flutamide Alone vs Flutamide + Vaccine + Sargramostim: Number of Participants With Prostatic Specific Antigen (PSA) Response

Source 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.

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.

GET https://conductscience.org/api/trials/v1/NCT00450463

GET https://conductscience.org/api/trials/v1/NCT00450463/events?page=2

API reference For AI assistants