Trial · NCT01341652

Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

NCT01341652, Phase 2, Completed, University of Wisconsin, Madison; results first posted 2020-11-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer. Trials, record NCT01341652. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01341652

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Trial

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

Title: Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
NCT number: NCT01341652
Status: Completed
Phases: Phase 2
Enrollment: 99 participants, actual
Lead sponsor: University of Wisconsin, Madison
Conditions: Prostate Cancer
Interventions: pTVG-HP, rhGM-CSF
First posted: 2011-04-26
Last updated: 2021-01-20
Results first posted: 2020-11-25

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	2-year Metastasis-Free Survival Rate	2 years	2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
Secondary	Prostate Specific Antigen (PSA) Doubling Time (DT)	up to 9 months	PSA DT was calculated using all serum PSA values available from the same clinical laboratory for the specified period by the equation log2/b where b denotes the least-squares estimator of the linear regression model of the log-transformed PSA values on time. Pretreatment PSA DT (3-6 months before treatment, with a minimum of 4 values), on-treatment PSA DT was determined using values from month 3 to month 9.
Secondary	Number and Severity of Observed Toxicities	2 years	Number of participants who experienced any adverse events greater than grade 1 that were determined to be at least possibly related to treatment, highest grade reported per participant for each adverse event (AE). All toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4). Higher grades indicate more severe toxicities.
Secondary	Median Time to Radiographic Disease Progression	up to 2 years	Time to metastasis was determined from the date of registration to the first CT or bone scan that demonstrated metastatic disease. As defined by RECIST 1.1 criteria.
Secondary	PSA Progression Free Survival	up to 2 years

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	2-year Metastasis-Free Survival Rate	2 years		percent probability	NUMBER
SECONDARY	Prostate Specific Antigen (PSA) Doubling Time (DT)	up to 9 months		months	MEDIAN
SECONDARY	Number and Severity of Observed Toxicities	2 years	Number of Severity of Adverse Events (AE) by grade complements the Adverse Events Section of this record.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Time to Radiographic Disease Progression	up to 2 years		months	MEDIAN
SECONDARY	PSA Progression Free Survival	up to 2 years		months	MEDIAN

Source ClinicalTrials.gov

Results by group176

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

Outcome	Group	Category	Value	Spread	Units
2-year Metastasis-Free Survival Rate	GM-CSF Alone		42.3		percent probability
2-year Metastasis-Free Survival Rate	pTVG-HP Vaccine With GM-CSF		41.8		percent probability
Prostate Specific Antigen (PSA) Doubling Time (DT)	GM-CSF Alone		8.9	Full Range 1.6 to 77.9	months
Prostate Specific Antigen (PSA) Doubling Time (DT)	pTVG-HP Vaccine With GM-CSF		5.4	Full Range 1.8 to 77.9	months
Number and Severity of Observed Toxicities	GM-CSF Alone	Chills / Grade 2	2		Participants
Number and Severity of Observed Toxicities	pTVG-HP Vaccine With GM-CSF	Chills / Grade 2	1		Participants
Number and Severity of Observed Toxicities	GM-CSF Alone	Chills / Grade 3	0		Participants
Number and Severity of Observed Toxicities	pTVG-HP Vaccine With GM-CSF	Chills / Grade 3	0		Participants
Number and Severity of Observed Toxicities	GM-CSF Alone	Chills / Grade 4	0		Participants
Number and Severity of Observed Toxicities	pTVG-HP Vaccine With GM-CSF	Chills / Grade 4	0		Participants

1 to 10 of 176Source ClinicalTrials.gov

See all 176 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	GM-CSF Alone	49
Overall Study	STARTED	pTVG-HP Vaccine With GM-CSF	50
Overall Study	COMPLETED	GM-CSF Alone	49
Overall Study	COMPLETED	pTVG-HP Vaccine With GM-CSF	48
Overall Study	NOT COMPLETED	GM-CSF Alone	0
Overall Study	NOT COMPLETED	pTVG-HP Vaccine With GM-CSF	2

Source ClinicalTrials.gov

Adverse events282

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	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	GM-CSF Alone	0	49	0
other	Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	pTVG-HP Vaccine With GM-CSF	1	50	1
other	Aortic valve disease	Cardiac disorders	GM-CSF Alone	1	49	1
other	Aortic valve disease	Cardiac disorders	pTVG-HP Vaccine With GM-CSF	1	50	1
other	Cardiac disorders - Other, specify	Cardiac disorders	GM-CSF Alone	1	49	1
other	Cardiac disorders - Other, specify	Cardiac disorders	pTVG-HP Vaccine With GM-CSF	1	50	4
other	Chest pain - cardiac	Cardiac disorders	GM-CSF Alone	1	49	1
other	Chest pain - cardiac	Cardiac disorders	pTVG-HP Vaccine With GM-CSF	1	50	1
other	Palpitations	Cardiac disorders	GM-CSF Alone	1	49	1
other	Palpitations	Cardiac disorders	pTVG-HP Vaccine With GM-CSF	2	50	2

1 to 10 of 282Source ClinicalTrials.gov

See all 282 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GM-CSF Alone	0	49
Total, all-cause mortality	pTVG-HP Vaccine With GM-CSF	0	50
Total, other adverse events	GM-CSF Alone	45	49
Total, other adverse events	pTVG-HP Vaccine With GM-CSF	49	50
Total, serious adverse events	GM-CSF Alone	6	49
Total, serious adverse events	pTVG-HP Vaccine With GM-CSF	3	50

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31644357	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 comparisons2

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

Comparison	Source
GM-CSF Alone vs pTVG-HP Vaccine With GM-CSF: deaths from any cause	Trial comparisons
GM-CSF Alone vs pTVG-HP Vaccine With GM-CSF: 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.

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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