Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01487863 |
Recruitment Status :
Completed
First Posted : December 8, 2011
Results First Posted : June 12, 2017
Last Update Posted : March 19, 2019
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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: Basic Science |
Conditions |
Prostate Cancer Metastatic Hormone Refractory Prostate Cancer Castration-resistant Prostate Cancer |
Interventions |
Biological: sipuleucel-T Drug: abiraterone acetate |
Enrollment | 69 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Concurrent Arm | Sequential Arm |
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Subjects received sipuleucel-T with concurrent abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
Period Title: Overall Study | ||
Started | 35 | 34 |
Subjects Randomized (Efficacy Analysis) | 35 | 34 |
Rcvd ≥1 Leukapheresis (Safety Analysis) | 35 | 34 |
Completed | 16 | 15 |
Not Completed | 19 | 19 |
Reason Not Completed | ||
Death | 19 | 19 |
Arm/Group Title | Concurrent Arm | Sequential Arm | Total | |
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Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 35 | 34 | 69 | |
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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 | 35 participants | 34 participants | 69 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
13 37.1%
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11 32.4%
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24 34.8%
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>=65 years |
22 62.9%
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23 67.6%
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45 65.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 35 participants | 34 participants | 69 participants | |
69.7 (9.8) | 70.5 (10.15) | 70.1 (9.91) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 35 participants | 34 participants | 69 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
35 100.0%
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34 100.0%
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69 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 35 participants | 34 participants | 69 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%
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2 5.9%
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2 2.9%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 5.7%
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3 8.8%
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5 7.2%
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White |
33 94.3%
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29 85.3%
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62 89.9%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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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 | 35 participants | 34 participants | 69 participants |
35 | 34 | 69 | ||
Weight
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 35 participants | 34 participants | 69 participants | |
94.22 (21.38) | 93.46 (16.29) | 93.85 (18.90) | ||
Height
Mean (Standard Deviation) Unit of measure: Centimeters |
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Number Analyzed | 35 participants | 34 participants | 69 participants | |
176.10 (8.25) | 177.39 (8.06) | 176.73 (8.12) | ||
Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 35 participants | 34 participants | 69 participants |
ECOG 0=Fully Active; No restrictions |
28 80.0%
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26 76.5%
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54 78.3%
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ECOG 1= Restricted Strenuous Activity |
7 20.0%
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8 23.5%
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15 21.7%
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[1]
Measure Description: ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
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Gleason Score
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 35 participants | 34 participants | 69 participants |
Gleason Score ≤ 6 |
5 14.3%
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5 14.7%
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10 14.5%
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Gleason Score = 7 |
12 34.3%
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8 23.5%
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20 29.0%
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Gleason Score ≥ 8 |
18 51.4%
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20 58.8%
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38 55.1%
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Gleason Score - Missing Data |
0 0.0%
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1 2.9%
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1 1.4%
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[1]
Measure Description: Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.
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Name/Title: | Shabnam Vaziri |
Organization: | Dendreon |
Phone: | 206-455-2323 |
EMail: | svaziri@Dendreon.com |
Responsible Party: | Dendreon |
ClinicalTrials.gov Identifier: | NCT01487863 |
Other Study ID Numbers: |
P11-3 |
First Submitted: | December 6, 2011 |
First Posted: | December 8, 2011 |
Results First Submitted: | March 27, 2017 |
Results First Posted: | June 12, 2017 |
Last Update Posted: | March 19, 2019 |