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

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ClinicalTrials.gov Identifier: NCT01309672
Recruitment Status : Active, not recruiting
First Posted : March 7, 2011
Results First Posted : May 5, 2017
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: abiraterone acetate
Drug: Prednisone
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description

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

Period Title: Overall Study
Started 41
Received Protocol Treatment 40
Completed 4
Not Completed 37
Reason Not Completed
Lack of Efficacy             20
Other             9
Adverse Event             5
Withdrawal by Subject             3
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description

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

Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
One patient is excluded due to patient not receiving any protocol treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
66
(39 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
0
   0.0%
Male
40
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 40 participants
Hispanic
4
  10.0%
Not Hispanic/unknown
36
  90.0%
Testosterone  
Median (Full Range)
Unit of measure:  ng/dL
Number Analyzed 40 participants
12.8
(3.0 to 50.0)
PSA at entry  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 40 participants
23.6
(11.7 to 64.4)
Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
0-1
39
  97.5%
2
1
   2.5%
[1]
Measure Description:

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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
2-6
3
   7.5%
7
7
  17.5%
8-10
30
  75.0%
[1]
Measure Description:

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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Bone
37
  92.5%
Lymph node
8
  20.0%
Visceral
6
  15.0%
Prostate RT  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Yes
5
  12.5%
No
35
  87.5%
Prostatectomy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Yes
5
  12.5%
No
35
  87.5%
Antiandrogen use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Yes
35
  87.5%
No
5
  12.5%
PSA status at registration  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Rising level
34
  85.0%
Stable/falling level
6
  15.0%
1.Primary Outcome
Title Number of Patients With Undetectable PSA
Hide Description undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of protocol treatment
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
5
  12.5%
2.Secondary Outcome
Title Number of Patients With PSA Partial Response
Hide Description PSA reduction to < 4 ng/ml, but >0.2 ng/ml
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
13
  32.5%
3.Secondary Outcome
Title Objective Progression-free Survival
Hide Description Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
17.5
(8.6 to 25.0)
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 40
Median (95% Confidence Interval)
Unit of Measure: months
25.8
(15.7 to 25.8)
5.Secondary Outcome
Title Number of Patients With Toxicity of Abiraterone Acetate
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least some protocol treatment
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: Participants
Alanine aminotransferase increased 2
Anorexia 1
Aspartate aminotransferase increased 2
Hyperglycemia 2
Hypertension 2
Hypokalemia 2
INR increased 1
Leukocytosis 1
Lung infection 1
Nausea 2
Rectal hemorrhage 1
Thromboembolic event 1
Vomiting 2
Weight gain 1
Time Frame Up to 3 years
Adverse Event Reporting Description Participants were monitored for toxicity every 2 weeks for the first 3 months, then monthly thereafter or at more frequent intervals appropriate for that participant, as judged by the treating physician.
 
Arm/Group Title Abiraterone Acetate + Prednisone
Hide Arm/Group Description 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
All-Cause Mortality
Abiraterone Acetate + Prednisone
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Abiraterone Acetate + Prednisone
Affected / at Risk (%)
Total   16/40 (40.00%) 
Blood and lymphatic system disorders   
Anemia   1/40 (2.50%) 
Leukocytosis   1/40 (2.50%) 
Cardiac disorders   
Aortic valve disease   1/40 (2.50%) 
Atrial flutter   1/40 (2.50%) 
Eye disorders   
Retinal detachment   1/40 (2.50%) 
Gastrointestinal disorders   
Abdominal pain   1/40 (2.50%) 
Constipation   1/40 (2.50%) 
Nausea   3/40 (7.50%) 
Rectal hemorrhage   1/40 (2.50%) 
Small intestinal obstruction   1/40 (2.50%) 
Vomiting   2/40 (5.00%) 
General disorders   
Death NOS   1/40 (2.50%) 
Fatigue   1/40 (2.50%) 
Fever   1/40 (2.50%) 
Hepatobiliary disorders   
Cholecystitis   1/40 (2.50%) 
Infections and infestations   
Lung infection   1/40 (2.50%) 
Urinary tract infection   1/40 (2.50%) 
Injury, poisoning and procedural complications   
Hip fracture   1/40 (2.50%) 
Injury, poison and procedural complications - Other   1/40 (2.50%) 
Postoperative hemorrhage   1/40 (2.50%) 
Investigations   
Alanine aminotransferase increased   2/40 (5.00%) 
Aspartate aminotransferase increased   2/40 (5.00%) 
Blood bilirubin increased   1/40 (2.50%) 
Metabolism and nutrition disorders   
Anorexia   1/40 (2.50%) 
Hyperglycemia   2/40 (5.00%) 
Hyperkalemia   1/40 (2.50%) 
Hypokalemia   1/40 (2.50%) 
Metabolism and nutrition disorders - Other, specify   1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Back pain   1/40 (2.50%) 
Musculoskeletal and connective tiss disorder - Other   1/40 (2.50%) 
Pain in extremity   1/40 (2.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified - Other   1/40 (2.50%) 
Nervous system disorders   
Paresthesia   1/40 (2.50%) 
Vascular disorders   
Hypertension   1/40 (2.50%) 
Thromboembolic event   2/40 (5.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abiraterone Acetate + Prednisone
Affected / at Risk (%)
Total   39/40 (97.50%) 
Blood and lymphatic system disorders   
Anemia   12/40 (30.00%) 
Blood and lymphatic system disorders - Other   3/40 (7.50%) 
Ear and labyrinth disorders   
Ear and labyrinth disorders-Other   2/40 (5.00%) 
Gastrointestinal disorders   
Abdominal pain   4/40 (10.00%) 
Constipation   9/40 (22.50%) 
Diarrhea   3/40 (7.50%) 
Gastroesophageal reflux disease   2/40 (5.00%) 
Gastrointestinal disorders-Other   2/40 (5.00%) 
Nausea   7/40 (17.50%) 
Vomiting   7/40 (17.50%) 
General disorders   
Chills   2/40 (5.00%) 
Edema limbs   8/40 (20.00%) 
Fatigue   15/40 (37.50%) 
Pain   6/40 (15.00%) 
Infections and infestations   
Bronchial infection   2/40 (5.00%) 
Infections and infestations-Other   3/40 (7.50%) 
Upper respiratory infection   4/40 (10.00%) 
Injury, poisoning and procedural complications   
Bruising   4/40 (10.00%) 
Fracture   3/40 (7.50%) 
Investigations   
Alanine aminotransferase increased   7/40 (17.50%) 
Alkaline phosphatase increased   14/40 (35.00%) 
Aspartate aminotransferase increased   10/40 (25.00%) 
Blood bilirubin increased   2/40 (5.00%) 
Creatinine increased   5/40 (12.50%) 
Lymphocyte count decreased   2/40 (5.00%) 
Platelet count decreased   4/40 (10.00%) 
Weight gain   5/40 (12.50%) 
Metabolism and nutrition disorders   
Anorexia   3/40 (7.50%) 
Dehydration   2/40 (5.00%) 
Hypercalcemia   3/40 (7.50%) 
Hyperglycemia   14/40 (35.00%) 
Hyperkalemia   2/40 (5.00%) 
Hypernatremia   5/40 (12.50%) 
Hypoalbuminemia   5/40 (12.50%) 
Hypocalcemia   5/40 (12.50%) 
Hypoglycemia   2/40 (5.00%) 
Hypokalemia   7/40 (17.50%) 
Hyponatremia   5/40 (12.50%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   4/40 (10.00%) 
Back pain   10/40 (25.00%) 
Bone pain   7/40 (17.50%) 
Chest wall pain   2/40 (5.00%) 
Flank pain   2/40 (5.00%) 
Generalized muscle weakness   3/40 (7.50%) 
Musculoskeletal and connective tiss disorder - Other   4/40 (10.00%) 
Myalgia   4/40 (10.00%) 
Pain in extremity   6/40 (15.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified - Other   2/40 (5.00%) 
Nervous system disorders   
Dizziness   5/40 (12.50%) 
Headache   4/40 (10.00%) 
Nervous system disorders-Other   2/40 (5.00%) 
Psychiatric disorders   
Insomnia   6/40 (15.00%) 
Renal and urinary disorders   
Urinary frequency   3/40 (7.50%) 
Reproductive system and breast disorders   
Pelvic pain   4/40 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough   6/40 (15.00%) 
Dyspnea   4/40 (10.00%) 
Epistaxis   2/40 (5.00%) 
Resp, thoracic and mediastinal disorders - Other   2/40 (5.00%) 
Skin and subcutaneous tissue disorders   
Rash acneiform   3/40 (7.50%) 
Skin and subcutaneous tissue disorders - Other   3/40 (7.50%) 
Surgical and medical procedures   
Surgical and medical procedures-Other   2/40 (5.00%) 
Vascular disorders   
Hot flashes   11/40 (27.50%) 
Hypertension   15/40 (37.50%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas W. Flaig, MD
Organization: University of Colorado, School of Medicine
EMail: Thomas.Flaig@ucdenver.edu
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01309672    
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: December 16, 2019