Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01727154 |
Recruitment Status :
Terminated
(Administrative reasons)
First Posted : November 15, 2012
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
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Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
- Study Details
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Study Type | Observational |
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Study Design | Observational Model: Case-Only; Time Perspective: Prospective |
Condition |
Prostate Cancer |
Intervention |
Biological: Sipuleucel-T |
Enrollment | 139 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Sipuleucel-T |
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Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. |
Period Title: Overall Study | |
Started | 139 |
Completed | 80 |
Not Completed | 59 |
Reason Not Completed | |
Death | 17 |
Withdrawal by Subject | 14 |
Subject Withdrew Consent | 18 |
Study Terminated | 6 |
No Discontinuation Documentation | 4 |
Baseline Characteristics
Arm/Group Title | Sipuleucel-T | |
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Sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals. | |
Overall Number of Baseline Participants | 139 | |
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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 | 139 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
33 23.7%
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>=65 years |
106 76.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 139 participants | |
71.8 (8.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 139 participants | |
Female |
0 0.0%
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Male |
139 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 139 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
1 0.7%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
23 16.5%
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White |
115 82.7%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 139 participants |
139 100.0%
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Height
Mean (Standard Deviation) Unit of measure: Centemeters |
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Number Analyzed | 139 participants | |
177.6 (6.8) | ||
Weight
Mean (Standard Deviation) Unit of measure: Kg |
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Number Analyzed | 139 participants | |
91.1 (19.2) | ||
Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 139 participants | |
28.8 (5.6) | ||
Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 139 participants |
ECOG=0 |
89 64.0%
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ECOG=1 |
34 24.5%
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ECOG=2 |
4 2.9%
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ECOG=3 |
3 2.2%
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Missing |
9 6.5%
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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 selfcare. Totally confined to bed or chair;5=Dead
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Gleason Sum Reported
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 139 participants |
Gleson Sum<= 6 | 14 | |
Gleson Sum=7 | 37 | |
Gleson Sum>= 8 | 63 | |
Missing | 25 | |
[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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Outcome Measures
Adverse Events
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed as a minimum of 200 patients were needed to obtain reliable data; however only 123 were treated. Given the small number of patients enrolled, analyses do not provide reliable results.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Results Point of Contact
Name/Title: | Shabnam Vaziri |
Organization: | Dendreon |
Phone: | 206.455.2323 |
EMail: | svaziri@Dendreon.com |
Responsible Party: | Dendreon |
ClinicalTrials.gov Identifier: | NCT01727154 |
Other Study ID Numbers: |
P11-4 |
First Submitted: | November 12, 2012 |
First Posted: | November 15, 2012 |
Results First Submitted: | August 23, 2018 |
Results First Posted: | August 19, 2019 |
Last Update Posted: | August 19, 2019 |