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Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01487863
First received: December 6, 2011
Last updated: May 11, 2017
Last verified: May 2017
History of Changes
Results First Received: March 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Basic Science
Conditions: Prostate Cancer Metastatic
Hormone Refractory Prostate Cancer
Castration-resistant Prostate Cancer
Interventions: Biological: sipuleucel-T
Drug: abiraterone acetate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Concurrent Arm

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.
Sequential Arm

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.

Participant Flow:   Overall Study
    Concurrent Arm   Sequential Arm
STARTED   35   34 
Subjects Randomized (Efficacy Analysis)   35   34 
Rcvd ≥1 Leukapheresis (Safety Analysis)   35   34 
COMPLETED   16   15 
NOT COMPLETED   19   19 
Death                19                19 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Concurrent Arm

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.
Sequential Arm

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 Total of all reporting groups

Baseline Measures
   Concurrent Arm   Sequential Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 35   34   69 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13  37.1%      11  32.4%      24  34.8% 
>=65 years      22  62.9%      23  67.6%      45  65.2% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 69.7  (9.8)   70.5  (10.15)   70.1  (9.91) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      35 100.0%      34 100.0%      69 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      2   5.9%      2   2.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   5.7%      3   8.8%      5   7.2% 
White      33  94.3%      29  85.3%      62  89.9% 
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% 
Region of Enrollment 
[Units: Participants]
 		     
United States   35   34   69 
Weight 
[Units: Kg]
Mean (Standard Deviation) 		 94.22  (21.38)   93.46  (16.29)   93.85  (18.90) 
Height 
[Units: Centimeters]
Mean (Standard Deviation) 		 176.10  (8.25)   177.39  (8.06)   176.73  (8.12) 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants 		     
ECOG 0=Fully Active; No restrictions   28   26   54 
ECOG 1= Restricted Strenuous Activity   7   8   15 
[1] 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
Gleason Score [1] 
[Units: Participants]
Count of Participants 		     
Gleason Score ≤ 6   5   5   10 
Gleason Score = 7   12   8   20 
Gleason Score ≥ 8   18   20   38 
Gleason Score - Missing Data   0   1   1 
[1] 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.


  Outcome Measures

1.  Primary:   Cumulative CD54 Upregulation Ratio Between the Cohorts.   [ Time Frame: Over the course of sipuleucel-T therapy (approximately 1 month) ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Shabnam Vaziri
Organization: Dendreon
phone: 206-455-2323
e-mail: svaziri@Dendreon.com



Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01487863     History of Changes
Other Study ID Numbers: P11-3
Study First Received: December 6, 2011
Results First Received: March 27, 2017
Last Updated: May 11, 2017