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
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters | 1 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. |
| Secondary | Participants Experiencing Adverse Events | From 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. |
| Secondary | Biochemical Recurrence Progression Free Survival Rate | 2 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters | 1 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 hpf | MEAN |
| SECONDARY | Participants Experiencing Adverse Events | From first dose of study treatment to one month post-prostatectomy (approximately 2 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Biochemical Recurrence Progression Free Survival Rate | 2 years | Two 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 survival | NUMBER |
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 Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters | Placebo Arm | 0.251560 | Standard Deviation 0.093458902 | VEGFR1+ clusters per hpf | |
| Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters | Pazopanib Arm | 0.269518 | Standard Deviation 0.120773334 | VEGFR1+ clusters per hpf | |
| Participants Experiencing Adverse Events | Placebo Arm | Participants experiencing Grade 1-2 Adverse Events | 15 | Participants | |
| Participants Experiencing Adverse Events | Pazopanib Arm | Participants experiencing Grade 1-2 Adverse Events | 15 | Participants | |
| Participants Experiencing Adverse Events | Placebo Arm | Participants experiencing Grade 3-4 Adverse Events | 0 | Participants | |
| Participants Experiencing Adverse Events | Pazopanib Arm | Participants experiencing Grade 3-4 Adverse Events | 4 | Participants | |
| Biochemical Recurrence Progression Free Survival Rate | Placebo Arm | 73.3 | 95% Confidence Interval 54.0 to 99.5 | percent chance of survival | |
| Biochemical Recurrence Progression Free Survival Rate | Pazopanib Arm | 92.3 | 95% Confidence Interval 78.9 to 100 | percent chance of survival |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Arm | 15 | |
| Overall Study | STARTED | Pazopanib Arm | 15 | |
| Overall Study | COMPLETED | Placebo Arm | 15 | |
| Overall Study | COMPLETED | Pazopanib Arm | 15 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 0 | |
| Overall Study | NOT COMPLETED | Pazopanib Arm | 0 |
Source ClinicalTrials.gov
Adverse events168
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 pain | Gastrointestinal disorders | Placebo Arm | 4 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Pazopanib Arm | 2 | 15 | |
| other | Agitation | Psychiatric disorders | Placebo Arm | 1 | 15 | |
| other | Agitation | Psychiatric disorders | Pazopanib Arm | 0 | 15 | |
| other | Alanine aminotransferase increased | Investigations | Placebo Arm | 0 | 15 | |
| other | Alanine aminotransferase increased | Investigations | Pazopanib Arm | 4 | 15 | 5 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Placebo Arm | 0 | 15 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Pazopanib Arm | 1 | 15 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo Arm | 2 | 15 | |
| other | Anemia | Blood and lymphatic system disorders | Pazopanib Arm | 0 | 15 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Arm | 0 | 15 |
| Total, all-cause mortality | Pazopanib Arm | 0 | 15 |
| Total, other adverse events | Placebo Arm | 15 | 15 |
| Total, other adverse events | Pazopanib Arm | 15 | 15 |
| Total, serious adverse events | Placebo Arm | 0 | 15 |
| Total, serious adverse events | Pazopanib Arm | 0 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30575560 | DERIVED |
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 |
|---|---|
| Pazopanib Arm vs Placebo Arm: deaths from any cause | Trial comparisons |
| Pazopanib Arm vs Placebo Arm: 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.
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