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S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309672
First Posted: March 7, 2011
Last Update Posted: June 2, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
Results First Submitted: March 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: abiraterone acetate
Drug: Prednisone

  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
Abiraterone Acetate + Prednisone

Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily

Prednisone, 5 mg, oral, 5 mg twice daily

abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily

Prednisone: 5 mg, oral, 5 mg twice daily


Participant Flow:   Overall Study
    Abiraterone Acetate + Prednisone
STARTED   41 
Received Protocol Treatment   40 
COMPLETED   4 
NOT COMPLETED   37 
Lack of Efficacy                20 
Other                9 
Adverse Event                5 
Withdrawal by Subject                3 



  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.
One patient is excluded due to patient not receiving any protocol treatment.

Reporting Groups
  Description
Abiraterone Acetate + Prednisone

Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily

Prednisone, 5 mg, oral, 5 mg twice daily

abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily

Prednisone: 5 mg, oral, 5 mg twice daily


Baseline Measures
   Abiraterone Acetate + Prednisone 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Median (Full Range)
 66 
 (39 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      40 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   2.5% 
Asian      2   5.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      10  25.0% 
White      27  67.5% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Ethnicity   
Hispanic      4  10.0% 
Not Hispanic/unknown      36  90.0% 
Testosterone 
[Units: ng/dL]
Median (Full Range)
 12.8 
 (3.0 to 50.0) 
PSA at entry 
[Units: ng/mL]
Median (Inter-Quartile Range)
 23.6 
 (11.7 to 64.4) 
Performance Status [1] 
[Units: Participants]
Count of Participants
 
0-1   39 
 1 
[1]

Zubrod Performance Status Scale:

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 work of a light or sedentary nature, e.g., light housework, office work.
  2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
  3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours.
  4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
Gleason Score [1] 
[Units: Participants]
Count of Participants
 
2-6   3 
 7 
8-10   30 
[1]

Pathologists grade prostate cancers using numbers from 1 to 5 based on how much the cells in the cancerous tissue look like normal tissue. This is called the Gleason system.

If the cancerous tissue looks like normal tissue, a grade of 1 is assigned. If the cancer cells look very abnormal, a grade of 5 is assigned. Grades 2-4 have features in between these extremes.

Since prostate cancers often have areas with different grades, a grade is assigned to the 2 areas that make up most of the cancer. These 2 grades are added to yield the Gleason score. The highest a Gleason score can be is 10.

Metastasis 
[Units: Participants]
Count of Participants
 
Bone   37 
Lymph node   8 
Visceral   6 
Prostate RT 
[Units: Participants]
Count of Participants
 
Yes   5 
No   35 
Prostatectomy 
[Units: Participants]
Count of Participants
 
Yes   5 
No   35 
Antiandrogen use 
[Units: Participants]
Count of Participants
 
Yes   35 
No   5 
PSA status at registration 
[Units: Participants]
Count of Participants
 
Rising level   34 
Stable/falling level   6 


  Outcome Measures
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1.  Primary:   Number of Patients With Undetectable PSA   [ Time Frame: 12 months ]

2.  Secondary:   Number of Patients With PSA Partial Response   [ Time Frame: 12 months ]

3.  Secondary:   Objective Progression-free Survival   [ Time Frame: 3 years ]

4.  Secondary:   Overall Survival   [ Time Frame: 3 years ]

5.  Secondary:   Number of Patients With Toxicity of Abiraterone Acetate   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Thomas W. Flaig, MD
Organization: University of Colorado, School of Medicine
e-mail: Thomas.Flaig@ucdenver.edu



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01309672     History of Changes
Other Study ID Numbers: CDR0000696565
S1014 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2011
First Posted: March 7, 2011
Results First Submitted: March 23, 2017
Results First Posted: May 5, 2017
Last Update Posted: June 2, 2017