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Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01717053
Recruitment Status : Active, not recruiting
First Posted : October 30, 2012
Results First Posted : September 24, 2018
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Duke University

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: Androgen deprivation
Radiation: Radiation Therapy
Drug: Prednisone
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abiraterone+Radiotherapy+ADT
Hide Arm/Group Description Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Period Title: Overall Study
Started 37
Completed 33
Not Completed 4
Arm/Group Title Abiraterone+Radiotherapy+ADT
Hide Arm/Group Description Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
66.0  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
0
   0.0%
Male
37
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
37
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  16.2%
White
31
  83.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Patients With Undetectable PSA at 1 Year
Hide Description The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all patients that completed protocol therapy.
Arm/Group Title Abiraterone+Radiotherapy+ADT
Hide Arm/Group Description:
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of participants
52
2.Secondary Outcome
Title PSA Nadir Value
Hide Description PSA nadir values at 1 and 2 years
Time Frame 1 year, 2 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to PSA Nadir
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Biochemical Progression-free Survival
Hide Description Disease progression defined as Phoenix RTOG definition of nadir + 2ng/ml or initiation of salvage therapy
Time Frame up to 2.5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Metastasis or Systemic Therapy
Hide Description Time to metastasis or systemic therapy
Time Frame up to 2.5 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Testosterone Recovery
Hide Description Time to testosterone recovery
Time Frame up to 2.5 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
Hide Description Proportion of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone
Time Frame 1 year, 2 years, 3 years, 4 years, 5 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Safety and Tolerability
Hide Description To evaluate the short and long term safety and tolerability of 6 months of abiraterone acetate with prednisone and ADT combined with standard RT in men with intermediate/lower high risk localized prostate cancer
Time Frame up to 7 months
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abiraterone+Radiotherapy+ADT
Hide Arm/Group Description Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
All-Cause Mortality
Abiraterone+Radiotherapy+ADT
Affected / at Risk (%)
Total   0/37 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Abiraterone+Radiotherapy+ADT
Affected / at Risk (%)
Total   4/37 (10.81%) 
General disorders   
Fever  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  1/37 (2.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Other, specify: Malignant melanoma  1  1/37 (2.70%) 
Psychiatric disorders   
Psychiatric disorders - Other, specify  1  1/37 (2.70%) 
Renal and urinary disorders   
Acute kidney injury  1  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders - Other, specify: Bilateral pleural effusion  1  1/37 (2.70%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abiraterone+Radiotherapy+ADT
Affected / at Risk (%)
Total   36/37 (97.30%) 
Blood and lymphatic system disorders   
Anemia  1  4/37 (10.81%) 
Cardiac disorders   
Atrial fibrillation  1  1/37 (2.70%) 
Cardiac disorders - Other, specify: Irregular heart beats  1  1/37 (2.70%) 
Chest pain - cardiac  1  1/37 (2.70%) 
Palpitations  1  1/37 (2.70%) 
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify: ""slight off balance and fluid in ears""  1  1/37 (2.70%) 
Ear and labyrinth disorders - Other, specify: Slight off balance  1  1/37 (2.70%) 
Ear pain  1  1/37 (2.70%) 
Vertigo  1  1/37 (2.70%) 
Eye disorders   
Blurred vision  1  2/37 (5.41%) 
Dry eye  1  1/37 (2.70%) 
Eye disorders - Other, specify: Left eye ""stye with morning crustiness""  1  1/37 (2.70%) 
Gastrointestinal disorders   
Abdominal distension  1  1/37 (2.70%) 
Colitis  1  1/37 (2.70%) 
Constipation  1  5/37 (13.51%) 
Diarrhea  1  10/37 (27.03%) 
Dry mouth  1  5/37 (13.51%) 
Dyspepsia  1  3/37 (8.11%) 
Esophageal pain  1  1/37 (2.70%) 
Fecal incontinence  1  2/37 (5.41%) 
Flatulence  1  1/37 (2.70%) 
Gastrointestinal disorders - Other, specify: Bowel urgency  1  1/37 (2.70%) 
Gastrointestinal disorders - Other, specify: Guaiac positive stools  1  1/37 (2.70%) 
Gastrointestinal disorders - Other, specify: Intermittent ""mucous loose stool""  1  1/37 (2.70%) 
Gastrointestinal disorders - Other, specify: Pt reports intermittent frank red blood on stool  1  1/37 (2.70%) 
Gastrointestinal disorders - Other, specify: diverticulitis  1  1/37 (2.70%) 
Gastrointestinal disorders - Other, specify: intermittent rectal bleeding  1  1/37 (2.70%) 
Gastrointestinal disorders - Other, specify: urgency with bowels  1  1/37 (2.70%) 
Gingival pain  1  1/37 (2.70%) 
Hemorrhoids  1  2/37 (5.41%) 
Nausea  1  4/37 (10.81%) 
Oral pain  1  1/37 (2.70%) 
Rectal pain  1  4/37 (10.81%) 
Toothache  1  1/37 (2.70%) 
Vomiting  1  3/37 (8.11%) 
General disorders   
Edema limbs  1  2/37 (5.41%) 
Fatigue  1  24/37 (64.86%) 
General disorders and administration site conditions - Other, specify: Injury left hand  1  1/37 (2.70%) 
General disorders and administration site conditions - Other, specify: Occasional cramping  1  1/37 (2.70%) 
General disorders and administration site conditions - Other, specify: Perineal pain  1  1/37 (2.70%) 
Injection site reaction  1  1/37 (2.70%) 
Irritability  1  3/37 (8.11%) 
Neck edema  1  1/37 (2.70%) 
Non-cardiac chest pain  1  1/37 (2.70%) 
Pain  1  4/37 (10.81%) 
Infections and infestations   
Infections and infestations - Other, specify: C diff colitis  1  1/37 (2.70%) 
Tooth infection  1  1/37 (2.70%) 
Urinary tract infection  1  1/37 (2.70%) 
Injury, poisoning and procedural complications   
Bruising  1  2/37 (5.41%) 
Burn  1  1/37 (2.70%) 
Fall  1  1/37 (2.70%) 
Injury, poisoning and procedural complications - Other, specify:Chigger bite  1  1/37 (2.70%) 
Injury, poisoning and procedural complications - Other, specify: Injury to Right Shin  1  1/37 (2.70%) 
Injury, poisoning and procedural complications - Other, specify: face injury  1  1/37 (2.70%) 
Investigations   
Alanine aminotransferase increased  1  12/37 (32.43%) 
Alkaline phosphatase increased  1  3/37 (8.11%) 
Aspartate aminotransferase increased  1  13/37 (35.14%) 
Blood bilirubin increased  1  3/37 (8.11%) 
Creatinine increased  1  1/37 (2.70%) 
Investigations - Other, specify: Blood Urea Nitrogen 20(7-18); 20 (8-20)  1  1/37 (2.70%) 
Investigations - Other, specify: Blood Urea Nitrogen 21 (8-20)  1  1/37 (2.70%) 
Investigations - Other, specify: Blood Urea Nitrogen 23 (7-18); 20 (8-20)  1  1/37 (2.70%) 
Investigations - Other, specify: Blood urea nitrogen 28;18  1  1/37 (2.70%) 
Investigations - Other, specify: CO2 level (carbon dioxide) 31  1  1/37 (2.70%) 
Investigations - Other, specify: CO2 level (carbon dioxide)31  1  1/37 (2.70%) 
Investigations - Other, specify: CO2 level (carbon dioxide)31 (23-30)  1  1/37 (2.70%) 
Investigations - Other, specify: Decreased ALT, <12 (7-56)  1  1/37 (2.70%) 
Investigations - Other, specify: Elevated CO2 (Carbon Dioxide) level at 31 (23-30)  1  1/37 (2.70%) 
Investigations - Other, specify: Elevated Total Bilirubin  1  1/37 (2.70%) 
Investigations - Other, specify: Elevated Total Bilirubin, decreased at 1.5  1  1/37 (2.70%) 
Investigations - Other, specify: Increased Albumin 5.0 (3.5-4.7)  1  1/37 (2.70%) 
Investigations - Other, specify: Increased CO2 (carbon dioxide) level, 31  1  1/37 (2.70%) 
Investigations - Other, specify: Low Chloride 96 (98-108)  1  1/37 (2.70%) 
Investigations - Other, specify: Low Chloride 97;on 3/31- 96 (98-108)  1  1/37 (2.70%) 
Investigations - Other, specify: Low serum creatinine, 0.66  1  1/37 (2.70%) 
Investigations - Other, specify: Minimally increased @ 32 (23-30)  1  1/37 (2.70%) 
Investigations - Other, specify: Serum Carbon Dioxide Level 32;28 (23-30)  1  1/37 (2.70%) 
Investigations - Other, specify: Serum Carbon Dioxide Level 34;29 (23-30)  1  1/37 (2.70%) 
Investigations - Other, specify: Weight loss, 83.7 kg (88 kg on 6/4/15)  1  1/37 (2.70%) 
Platelet count decreased  1  1/37 (2.70%) 
Urine output decreased  1  1/37 (2.70%) 
Weight gain  1  1/37 (2.70%) 
Weight loss  1  2/37 (5.41%) 
White blood cell decreased  1  1/37 (2.70%) 
Metabolism and nutrition disorders   
Acidosis  1  1/37 (2.70%) 
Anorexia  1  2/37 (5.41%) 
Hyperglycemia  1  8/37 (21.62%) 
Hyperkalemia  1  1/37 (2.70%) 
Hypocalcemia  1  1/37 (2.70%) 
Hypokalemia  1  8/37 (21.62%) 
Hyponatremia  1  3/37 (8.11%) 
Metabolism and nutrition disorders - Other, specify: Possible mineralcorticoid excess (hypokalemia)  1  1/37 (2.70%) 
Metabolism and nutrition disorders - Other, specify: elevated ALT/AST  1  1/37 (2.70%) 
Metabolism and nutrition disorders - Other, specify: low Total Protein level- 5.8 (6.1-8.1)  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/37 (2.70%) 
Back pain  1  2/37 (5.41%) 
Chest wall pain  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorder - Other, specify: Chronic left hip/sciatica pain  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorder - Other, specify: Decreased strength & endurance  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorder - Other, specify: L4-L5 procedure on 8/4/15  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorder - Other, specify: Right Lower Extremity leg spasm  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorder - Other, specify: Right flank pain  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorder - Other, specify: bursitis, left knee  1  1/37 (2.70%) 
Musculoskeletal and connective tissue disorder - Other, specify: restless legs  1  1/37 (2.70%) 
Pain in extremity  1  2/37 (5.41%) 
Nervous system disorders   
Dizziness  1  4/37 (10.81%) 
Dysgeusia  1  1/37 (2.70%) 
Headache  1  4/37 (10.81%) 
Memory impairment  1  2/37 (5.41%) 
Nervous system disorders - Other, specify: Chronic sciatic back pain  1  1/37 (2.70%) 
Nervous system disorders - Other, specify: Pre-treatment, chronic sciatic back pain  1  1/37 (2.70%) 
Nervous system disorders - Other, specify: lightheaded, when standing  1  1/37 (2.70%) 
Paresthesia  1  2/37 (5.41%) 
Presyncope  1  1/37 (2.70%) 
Somnolence  1  1/37 (2.70%) 
Psychiatric disorders   
Agitation  1  1/37 (2.70%) 
Anxiety  1  1/37 (2.70%) 
Depression  1  1/37 (2.70%) 
Insomnia  1  5/37 (13.51%) 
Libido decreased  1  6/37 (16.22%) 
Psychiatric disorders - Other, specify  1  1/37 (2.70%) 
Restlessness  1  1/37 (2.70%) 
Renal and urinary disorders   
Cystitis noninfective  1  4/37 (10.81%) 
Hematuria  1  2/37 (5.41%) 
Renal and urinary disorders - Other, specify: Dysuria  1  1/37 (2.70%) 
Renal and urinary disorders - Other, specify: Increased urination  1  1/37 (2.70%) 
Renal and urinary disorders - Other, specify: Nocturia  1  2/37 (5.41%) 
Renal and urinary disorders - Other, specify: Slow urinary stream  1  1/37 (2.70%) 
Renal and urinary disorders - Other, specify: Urinary hesistancy  1  1/37 (2.70%) 
Renal and urinary disorders - Other, specify: Urinary hesitancy  1  3/37 (8.11%) 
Renal and urinary disorders - Other, specify: Weak urinary stream  1  1/37 (2.70%) 
Renal and urinary disorders - Other, specify: nocturia  1  1/37 (2.70%) 
Renal and urinary disorders - Other, specify: weak stream  1  1/37 (2.70%) 
Urinary frequency  1  20/37 (54.05%) 
Urinary incontinence  1  5/37 (13.51%) 
Urinary retention  1  2/37 (5.41%) 
Urinary tract pain  1  6/37 (16.22%) 
Urinary urgency  1  5/37 (13.51%) 
Reproductive system and breast disorders   
Erectile dysfunction  1  3/37 (8.11%) 
Gynecomastia  1  2/37 (5.41%) 
Perineal pain  1  1/37 (2.70%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/37 (13.51%) 
Dyspnea  1  4/37 (10.81%) 
Laryngeal inflammation  1  1/37 (2.70%) 
Nasal congestion  1  4/37 (10.81%) 
Pleural effusion  1  1/37 (2.70%) 
Postnasal drip  1  1/37 (2.70%) 
Productive cough  1  2/37 (5.41%) 
Respiratory, thoracic and mediastinal disorders - Other, specify: Dry nose  1  1/37 (2.70%) 
Sleep apnea  1  1/37 (2.70%) 
Sore throat  1  2/37 (5.41%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  3/37 (8.11%) 
Erythema multiforme  1  2/37 (5.41%) 
Pruritus  1  2/37 (5.41%) 
Rash maculo-papular  1  2/37 (5.41%) 
Skin and subcutaneous tissue disorders - Other, specify:  1  1/37 (2.70%) 
Skin and subcutaneous tissue disorders - Other, specify: Basal cell carcinoma of left ear  1  1/37 (2.70%) 
Skin and subcutaneous tissue disorders - Other, specify: Melanoma of lower back  1  1/37 (2.70%) 
Skin and subcutaneous tissue disorders - Other, specify: Melanoma of right shoulder  1  1/37 (2.70%) 
Skin and subcutaneous tissue disorders - Other, specify: Soft non-tender area on lower leg  1  1/37 (2.70%) 
Skin and subcutaneous tissue disorders - Other, specify: skin pallor, pale  1  1/37 (2.70%) 
Vascular disorders   
Hot flashes  1  28/37 (75.68%) 
Hypertension  1  22/37 (59.46%) 
Vascular disorders - Other, specify: Facial petechiae ""from force of vomiting"" per pt  1  1/37 (2.70%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Bridget Koontz
Organization: Duke University
Phone: 919-668-5213
EMail: bridget.koontz@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01717053     History of Changes
Other Study ID Numbers: Pro00044071
First Submitted: October 26, 2012
First Posted: October 30, 2012
Results First Submitted: August 23, 2018
Results First Posted: September 24, 2018
Last Update Posted: May 6, 2019