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

Study Type:	Interventional
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

  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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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) ]

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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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: 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
e-mail: svaziri@Dendreon.com

Responsible Party:	Dendreon
ClinicalTrials.gov Identifier:	NCT01487863 History of Changes
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:	June 12, 2017