ConductScience.org, home

Trial · NCT01832259

A Study of VEGF Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection

NCT01832259, Phase 2, Completed, University of Utah; results first posted 2018-06-12

3 sourcestrials-2026-11-12-0.5.0

Download JSON
Cite this record

ConductScience Library. A Study of VEGF Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection. Trials, record NCT01832259. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01832259

On this page

Trial

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

Title
A Study of VEGF Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection
NCT number
NCT01832259
Status
Completed
Phases
Phase 2
Enrollment
30 participants, actual
Lead sponsor
University of Utah
Conditions
Adenocarcinoma of the Prostate
Interventions
Pazopanib, Placebo
First posted
2013-04-16
Last updated
2018-12-12
Results first posted
2018-06-12

Source ClinicalTrials.gov

Registered outcomes3

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

ListOutcomeTime frameDescription
PrimaryNumber of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters1 month
Patients with high-risk, localized prostate cancer were treated with 28 days of Pazopanib or placebo, after which they underwent radical prostatectomy. During prostatectomy, benign pelvic lymph node tissue was collected and subsequently analyzed for the average number of VEGFR1-positive clusters in 8 distinct 40x microscopic fields as an indicator of pre-metastatic niche formation.
SecondaryParticipants Experiencing Adverse EventsFrom first dose of study treatment to one month post-prostatectomy (approximately 2 months)
Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4. Each event was assigned a grade (1-5), with lower grades indicating milder events. All adverse events were recorded, regardless of attribution to study treatment. For a full listing of Adverse Events, please see the Adverse Events section of the Results for this study.
SecondaryBiochemical Recurrence Progression Free Survival Rate2 years
Following prostatectomy, patients' Prostate Specific Antigen (PSA) lab values were collected for up to two years. Biochemical recurrence was defined as the first PSA lab value of greater than or equal to 0.2 ng/mL following prostatectomy. Biochemical recurrence progression free survival rate was defined as the percent chance of 1 year survival with no biochemical recurrence.

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters1 month
The tissue of one patient on the Pazopanib arm and two patients on the Placebo arm was not able to be analyzed. Another patient on the Pazopanib arm had surgery delayed by a few weeks following stopping study medication and was determined to be unevaluable, resulting in 13 patients analyzed on each arm.
VEGFR1+ clusters per hpfMEAN
SECONDARYParticipants Experiencing Adverse EventsFrom first dose of study treatment to one month post-prostatectomy (approximately 2 months)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBiochemical Recurrence Progression Free Survival Rate2 yearsTwo patients on the Pazopanib arm were not evaluable, one due to prostatectomy not being completed, and one due to prostatectomy being delayed outside of protocol windows.percent chance of survivalNUMBER

Results by group8

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

OutcomeGroupCategoryValueSpreadUnits
Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive ClustersPlacebo Arm0.251560Standard Deviation 0.093458902VEGFR1+ clusters per hpf
Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive ClustersPazopanib Arm0.269518Standard Deviation 0.120773334VEGFR1+ clusters per hpf
Participants Experiencing Adverse EventsPlacebo ArmParticipants experiencing Grade 1-2 Adverse Events15Participants
Participants Experiencing Adverse EventsPazopanib ArmParticipants experiencing Grade 1-2 Adverse Events15Participants
Participants Experiencing Adverse EventsPlacebo ArmParticipants experiencing Grade 3-4 Adverse Events0Participants
Participants Experiencing Adverse EventsPazopanib ArmParticipants experiencing Grade 3-4 Adverse Events4Participants
Biochemical Recurrence Progression Free Survival RatePlacebo Arm73.395% Confidence Interval 54.0 to 99.5percent chance of survival
Biochemical Recurrence Progression Free Survival RatePazopanib Arm92.395% Confidence Interval 78.9 to 100percent chance of survival

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPlacebo Arm15
Overall StudySTARTEDPazopanib Arm15
Overall StudyCOMPLETEDPlacebo Arm15
Overall StudyCOMPLETEDPazopanib Arm15
Overall StudyNOT COMPLETEDPlacebo Arm0
Overall StudyNOT COMPLETEDPazopanib Arm0

Adverse events168

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAbdominal painGastrointestinal disordersPlacebo Arm415
otherAbdominal painGastrointestinal disordersPazopanib Arm215
otherAgitationPsychiatric disordersPlacebo Arm115
otherAgitationPsychiatric disordersPazopanib Arm015
otherAlanine aminotransferase increasedInvestigationsPlacebo Arm015
otherAlanine aminotransferase increasedInvestigationsPazopanib Arm4155
otherAlopeciaSkin and subcutaneous tissue disordersPlacebo Arm015
otherAlopeciaSkin and subcutaneous tissue disordersPazopanib Arm115
otherAnemiaBlood and lymphatic system disordersPlacebo Arm215
otherAnemiaBlood and lymphatic system disordersPazopanib Arm015

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo Arm015
Total, all-cause mortalityPazopanib Arm015
Total, other adverse eventsPlacebo Arm1515
Total, other adverse eventsPazopanib Arm1515
Total, serious adverse eventsPlacebo Arm015
Total, serious adverse eventsPazopanib Arm015

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30575560DERIVED

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.

ComparisonSource
Pazopanib Arm vs Placebo Arm: deaths from any causeTrial comparisons
Pazopanib Arm vs Placebo Arm: serious adverse eventsTrial 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/NCT01832259

GET https://conductscience.org/api/trials/v1/NCT01832259/events?page=2