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Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)

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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
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Prostate Cancer
Intervention Biological: Sipuleucel-T
Enrollment 139
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description 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
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
  23.7%
>=65 years
106
  76.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants
71.8  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants
Female
0
   0.0%
Male
139
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
23
  16.5%
White
115
  82.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 139 participants
139
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centemeters
Number Analyzed 139 participants
177.6  (6.8)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 139 participants
91.1  (19.2)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
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%
ECOG=1
34
  24.5%
ECOG=2
4
   2.9%
ECOG=3
3
   2.2%
Missing
9
   6.5%
[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
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.
1.Primary Outcome
Title The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
Hide Description The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
Time Frame Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to administrative reasons. A min of 200 patients were needed to obtain reliable data but only 139 were enrolled, 123 treated only 118 had analyzable immune response samples. Therefore this was a descriptive analysis of only 118pts with an immune response after dosing with Provenge. No comparative group available.
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description:
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 Participants Analyzed 118
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects who had an immune response
110
  93.2%
Subjects who did not have an immune response
8
   6.8%
Time Frame All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Reporting requirements for serious adverse events (SAEs) are described in the respective protocols (P10-3 and P12-1) for the trial in which each subject is concurrently enrolled.
Adverse Event Reporting Description

All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were not monitored/assessed.

Reporting requirements for serious adverse events (SAEs) are described in the respective protocols (P10-3 and P12-1) for the trial in which each subject is concurrently enrolled.
 
Arm/Group Title Sipuleucel-T
Hide Arm/Group Description 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.
All-Cause Mortality
Sipuleucel-T
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
Sipuleucel-T
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sipuleucel-T
Affected / at Risk (%)
Total   0/0 
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.
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Shabnam Vaziri
Organization: Dendreon
Phone: 206.455.2323
EMail: svaziri@Dendreon.com
Layout table for additonal information
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