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PROvenge Treatment and Early Cancer Treatment (PROTECT)

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ClinicalTrials.gov Identifier: NCT00779402
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Other: Control
Biological: Sipuleucel-T

  Participant Flow

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
Sipuleucel-T

Provenge

Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF

Control

Control

Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen


Participant Flow for 3 periods

Period 1:   Treatment Phase 1
    Sipuleucel-T   Control
STARTED   117   59 
Received ≥1 Leukapherisis (Safety Set)   116   59 
Received ≥1 Study Product (Exposure Set)   113   59 
Received Booster Infusion   50   30 
COMPLETED [1]   84   44 
NOT COMPLETED   33   15 
Disease Progression                1                0 
Adverse Event                2                0 
Protocol Violation                1                0 
Patient Refused to Continue                17                2 
Lost to Follow-up                0                1 
Death                0                1 
Intercurrent Illness                1                1 
Withdrawal by Subject                1                0 
Not Specified                4                2 
Closure of Study                3                2 
Completed Protocol Visits                3                6 
[1] Completed 3 scheduled infusion treatments and had confirmed Biochemical Failure (BF).

Period 2:   Surveillance Phase
    Sipuleucel-T   Control
STARTED   84   44 
COMPLETED [1]   41   13 
NOT COMPLETED   43   31 
Protocol Violation                0                1 
Patient refused to continue                22                14 
Lost to Follow-up                2                1 
Death                0                1 
Intercurrent Illness                2                0 
Not specified                5                5 
Withdrawal by Subject                4                1 
Closure of study                5                6 
Completed Protocol Visits                3                2 
[1] Reached Distant Failure (DF) following Treatment Phase.

Period 3:   Long-term Follow-up
    Sipuleucel-T   Control
STARTED   41   13 
COMPLETED [1]   20   7 
NOT COMPLETED   21   6 
Patient refused to continue                2                0 
Not specified                5                0 
Closure of Study                8                4 
Completed Protocol Visits                6                2 
[1] Subject survival status was assessed by phone Q6 months until death of subject. Death=Completion.



  Baseline Characteristics

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
Sipuleucel-T

Provenge

Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF

Control

Control

Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen

Total Total of all reporting groups

Baseline Measures
   Sipuleucel-T   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 117   59   176 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.4  (7.40)   65.2  (6.75)   64.7  (7.18) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      117 100.0%      59 100.0%      176 100.0% 
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%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      9   7.7%      3   5.1%      12   6.8% 
White      107  91.5%      55  93.2%      162  92.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   0.9%      1   1.7%      2   1.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   117   59   176 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants
     
ECOG 0=Fully Active; No restrictions.   109   57   166 
ECOG 1= Restricted Strenuous Activity   6   1   7 
ECOG Missing   2   1   3 
[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
Weight 
[Units: Kg]
Mean (Standard Deviation)
 90.45  (15.52)   89.70  (13.85)   90.21  (14.95) 
Gleason Score [1] 
[Units: Participants]
Count of Participants
     
Gleason Score ≤ 6   20   13   33 
Gleason Score =7   69   34   103 
Gleason Score ≥ 8   28   12   40 
[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.
Time from diagnosis to randomization 
[Units: Years]
Mean (Standard Deviation)
 5.84  (2.76)   6.34  (2.76)   6.01  (2.76) 


  Outcome Measures

1.  Primary:   Time to Biochemical Failure Cumulative Incidence Percentile   [ Time Frame: Every 3 months post-infusion ]

2.  Primary:   Number of Subjects That Met Biochemical Failure Status   [ Time Frame: Every 3 months post-infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00779402     History of Changes
Other Study ID Numbers: P-11
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: April 10, 2017
Results First Posted: January 29, 2018
Last Update Posted: January 29, 2018