Trial · NCT01875250
Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
NCT01875250, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-09-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer. Trials, record NCT01875250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01875250
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
- NCT number
- NCT01875250
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Prostate Cancer
- Interventions
- PROSTVAC-F (Fowlpox)/TRICOM, PROSTVAC-V (Vaccinia)/TRICOM, Enzalutamide (Xtandi)
- First posted
- 2013-06-11
- Last updated
- 2020-09-16
- Results first posted
- 2020-09-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Growth Rate | 7 months | Growth rate was measured using the growth rate equation -f(t) = exp (-d\*t) + exp (g\*t) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics. |
| Secondary | Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide | 30 Days After the Start of Course 1 and Course 2 of Enzalutamide | VEGF was measured by the enzyme-linked immunosorbent assay (ELISA) assay. The lower limit of quantitation of assay was 9.0 pg/ml. |
| Secondary | Median Testosterone After 84 Days of Enzalutamide | 84 days | Normal testosterone is 270-1070 nd/dL. |
| Secondary | Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1 | 84 days | Median PSA change would be considered optimal. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for 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 | Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide | up to 41 months | PSA recovery is defined as the return above baseline PSA in participants with normal testosterone and non-metastatic, castration sensitive prostate cancer. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Growth Rate | 7 months | unitless | NUMBER | |
| SECONDARY | Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide | 30 Days After the Start of Course 1 and Course 2 of Enzalutamide | It was pre-specified to combine analysis for Arms of growth factors. | pg/ml | MEAN |
| SECONDARY | Median Testosterone After 84 Days of Enzalutamide | 84 days | It was pre-specified to combine analysis for testosterone. In addition, data was not analyzed beyond Course 1 because it was not part of the initial statistical plan. | ng/dl | MEDIAN |
| SECONDARY | Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1 | 84 days | Percent change | MEDIAN | |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide | up to 41 months | It was pre-specified to combine analysis for Arms of PSA Recovery time. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Growth Rate | Arm A - Enzalutamide for 3 Months | 0.031 | unitless | ||
| Tumor Growth Rate | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 0.030 | unitless | ||
| Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide | All Participants | Course 1 | 192 | Standard Deviation 82 | pg/ml |
| Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide | All Participants | Course 2 | 165.04 | Standard Deviation 82.38 | pg/ml |
| Median Testosterone After 84 Days of Enzalutamide | All Participants | 834 | Full Range 308 to 1579 | ng/dl | |
| Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1 | Arm A - Enzalutamide for 3 Months | -99 | Full Range -84 to -99 | Percent change | |
| Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1 | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | -99 | Full Range -87 to -99 | Percent change | |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Arm A - Enzalutamide for 3 Months | 19 | Participants | ||
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 19 | Participants | ||
| Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide | All Participants | Course 1 | 224 | Full Range 84 to 1246 | Days |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - Enzalutamide for 3 Months | 19 | |
| Overall Study | STARTED | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 19 | |
| Overall Study | COMPLETED | Arm A - Enzalutamide for 3 Months | 17 | |
| Overall Study | COMPLETED | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 19 | |
| Overall Study | NOT COMPLETED | Arm A - Enzalutamide for 3 Months | 2 | |
| Overall Study | NOT COMPLETED | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 0 |
Source ClinicalTrials.gov
Adverse events306
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 | Arm A - Enzalutamide for 3 Months | 1 | 19 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 1 | 19 | 2 |
| other | Alanine aminotransferase increased | Investigations | Arm A - Enzalutamide for 3 Months | 5 | 19 | 9 |
| other | Alanine aminotransferase increased | Investigations | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 5 | 19 | 8 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm A - Enzalutamide for 3 Months | 3 | 19 | 3 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 2 | 19 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Arm A - Enzalutamide for 3 Months | 5 | 19 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 8 | 19 | 11 |
| other | Anorexia | Metabolism and nutrition disorders | Arm A - Enzalutamide for 3 Months | 3 | 19 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 4 | 19 | 5 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - Enzalutamide for 3 Months | 0 | 19 |
| Total, all-cause mortality | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 0 | 19 |
| Total, other adverse events | Arm A - Enzalutamide for 3 Months | 19 | 19 |
| Total, other adverse events | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 19 | 19 |
| Total, serious adverse events | Arm A - Enzalutamide for 3 Months | 0 | 19 |
| Total, serious adverse events | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | 1 | 19 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A - Enzalutamide for 3 Months vs Arm B - Enzalutamide for 3 Months + PSA-TRICOM: deaths from any cause | Trial comparisons |
Arm A - Enzalutamide for 3 Months vs Arm B - Enzalutamide for 3 Months + PSA-TRICOM: Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Trial comparisons |
| Arm A - Enzalutamide for 3 Months vs Arm B - Enzalutamide for 3 Months + PSA-TRICOM: 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/NCT01875250
GET https://conductscience.org/api/trials/v1/NCT01875250/events?page=2