Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01875250 |
Recruitment Status :
Completed
First Posted : June 11, 2013
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Prostate Cancer |
Interventions |
Biological: PROSTVAC-F (Fowlpox)/TRICOM Biological: PROSTVAC-V (Vaccinia)/TRICOM Drug: Enzalutamide (Xtandi) |
Enrollment | 38 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm A - Enzalutamide for 3 Months | Arm B - Enzalutamide for 3 Months + PSA-TRICOM |
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Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor. |
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor. |
Period Title: Overall Study | ||
Started | 19 | 19 |
Completed | 17 | 19 |
Not Completed | 2 | 0 |
Reason Not Completed | ||
Adverse Event | 2 | 0 |
Arm/Group Title | Arm A - Enzalutamide for 3 Months | Arm B - Enzalutamide for 3 Months + PSA-TRICOM | Total | |
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Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor. |
Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 19 | 19 | 38 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | 19 participants | 38 participants | |
<=18 years |
0 0.0%
|
0 0.0%
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0 0.0%
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Between 18 and 65 years |
8 42.1%
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12 63.2%
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20 52.6%
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>=65 years |
11 57.9%
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7 36.8%
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18 47.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 19 participants | 19 participants | 38 participants | |
65.7 (8.46) | 66.07 (5.29) | 65.88 (6.87) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | 19 participants | 38 participants | |
Female |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Male |
19 100.0%
|
19 100.0%
|
38 100.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | 19 participants | 38 participants | |
Hispanic or Latino |
0 0.0%
|
0 0.0%
|
0 0.0%
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|
Not Hispanic or Latino |
19 100.0%
|
19 100.0%
|
38 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 19 participants | 19 participants | 38 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
|
0 0.0%
|
|
Black or African American |
4 21.1%
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3 15.8%
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7 18.4%
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White |
15 78.9%
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16 84.2%
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31 81.6%
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More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 19 participants | 19 participants | 38 participants |
19 | 19 | 38 |
Name/Title: | Dr. Ravi A. Madan |
Organization: | National Cancer Institute |
Phone: | 301-480-7168 |
EMail: | m480i@nih.gov |
Responsible Party: | Ravi A. Madan, M.D., National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT01875250 |
Other Study ID Numbers: |
130153 13-C-0153 |
First Submitted: | June 7, 2013 |
First Posted: | June 11, 2013 |
Results First Submitted: | August 13, 2020 |
Results First Posted: | September 16, 2020 |
Last Update Posted: | September 16, 2020 |