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Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer (KHAD)

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ClinicalTrials.gov Identifier: NCT00673127
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Massachusetts General Hospital
Dana-Farber Cancer Institute
Sunnybrook Health Sciences Centre
Oregon Health and Science University
M.D. Anderson Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Information provided by (Responsible Party):
Steven Balk, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Ketoconazole, Hydrocortisone and Dutasteride
Enrollment 57
Recruitment Details Medical oncology clinics
Pre-assignment Details Required 6 week washout for any AR antagonists
Arm/Group Title KHAD
Hide Arm/Group Description KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC
Period Title: Overall Study
Started 57
Completed 57
Not Completed 0
Arm/Group Title KHAD
Hide Arm/Group Description Ketoconazole, Hydrocortisone and Dutasteride
Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  56.1%
>=65 years
25
  43.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
62  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
0
   0.0%
Male
57
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 57 participants
United States 49
Canada 8
1.Primary Outcome
Title PSA Response
Hide Description PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Time Frame From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KHAD
Hide Arm/Group Description:
Ketoconazole, Hydrocortisone and Dutasteride
Overall Number of Participants Analyzed 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(42.4 to 69.3)
2.Secondary Outcome
Title Time to Progression
Hide Description Duration of time from treatment initiation until documented progression (PSA or Disease progression)
Time Frame Duration of time from treatment initiation until documented progression. Maximum 32 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KHAD
Hide Arm/Group Description:
KHAD: ketoconazole, hydrocortisone and dutasteride for CRPC
Overall Number of Participants Analyzed 57
Median (95% Confidence Interval)
Unit of Measure: months
14.5
(11 to 17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KHAD
Hide Arm/Group Description Ketoconazole, Hydrocortisone and Dutasteride
All-Cause Mortality
KHAD
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
KHAD
Affected / at Risk (%) # Events
Total   1/57 (1.75%)    
Vascular disorders   
grade 4 thrombosis *  1/57 (1.75%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
KHAD
Affected / at Risk (%) # Events
Total   56/57 (98.25%)    
Blood and lymphatic system disorders   
Hemoglobin  1  23/57 (40.35%) 
Hematologic-other  1  1/57 (1.75%) 
Cardiac disorders   
Cardiomyopathy, restrictive  1  1/57 (1.75%) 
Cardiac-other  1  1/57 (1.75%) 
Ear and labyrinth disorders   
Tinnitus  1  1/57 (1.75%) 
Endocrine disorders   
Endocrine-other  1  1/57 (1.75%) 
Eye disorders   
Cataract  1  1/57 (1.75%) 
Dry eye syndrome  1  3/57 (5.26%) 
Vision-blurred  1  2/57 (3.51%) 
Tearing  1  1/57 (1.75%) 
Ocular-other  1  2/57 (3.51%) 
Gastrointestinal disorders   
Constipation  1  5/57 (8.77%) 
Diarrhea w/o prior colostomy  1  4/57 (7.02%) 
Distention/bloating, abdominal  1  1/57 (1.75%) 
Dry mouth  1  4/57 (7.02%) 
Esophagitis  1  1/57 (1.75%) 
Flatulence  1  1/57 (1.75%) 
Gastritis  1  1/57 (1.75%) 
Dyspepsia  1  6/57 (10.53%) 
Incontinence, anal  1  1/57 (1.75%) 
Nausea  1  14/57 (24.56%) 
Vomiting  1  4/57 (7.02%) 
GI-other  1  5/57 (8.77%) 
General disorders   
Fatigue  1  21/57 (36.84%) 
Fever w/o neutropenia  1  1/57 (1.75%) 
Constitutional, other  1  6/57 (10.53%) 
Edema head and neck  1  1/57 (1.75%) 
Edema limb  1  10/57 (17.54%) 
Pain-other  1  5/57 (8.77%) 
Infections and infestations   
Infection Gr0-2 neut, sinus  1  1/57 (1.75%) 
Infection-other  1  1/57 (1.75%) 
Injury, poisoning and procedural complications   
Bruising  1  2/57 (3.51%) 
Investigations   
Lymphopenia  1  3/57 (5.26%) 
Weight gain  1  2/57 (3.51%) 
Alkaline phosphatase  1  6/57 (10.53%) 
ALT, SGPT  1  27/57 (47.37%) 
AST, SGOT  1  29/57 (50.88%) 
Bilirubin  1  3/57 (5.26%) 
Creatinine  1  15/57 (26.32%) 
Metabolic/Laboratory-other  1  2/57 (3.51%) 
Metabolism and nutrition disorders   
Pancreatic glucose intolerance  1  1/57 (1.75%) 
Hypoalbuminemia  1  1/57 (1.75%) 
Hypocalcemia  1  1/57 (1.75%) 
Hyperglycemia  1  21/57 (36.84%) 
Hypoglycemia  1  4/57 (7.02%) 
Hypomagnesemia  1  1/57 (1.75%) 
Hyperkalemia  1  2/57 (3.51%) 
Hypokalemia  1  6/57 (10.53%) 
Hyponatremia  1  1/57 (1.75%) 
Hyperuricemia  1  2/57 (3.51%) 
Musculoskeletal and connective tissue disorders   
Nonneuropathic lower extr muscle weak  1  2/57 (3.51%) 
Nonneuropathic generalized weakness  1  1/57 (1.75%) 
Back, pain  1  1/57 (1.75%) 
Extremity-limb, pain  1  1/57 (1.75%) 
Nervous system disorders   
Taste disturbance  1  6/57 (10.53%) 
Cognitive disturbance  1  1/57 (1.75%) 
Dizziness  1  2/57 (3.51%) 
Memory impairment  1  1/57 (1.75%) 
Neuropathy-sensory  1  1/57 (1.75%) 
Neurologic-other  1  3/57 (5.26%) 
Head/headache  1  4/57 (7.02%) 
Psychiatric disorders   
Insomnia  1  5/57 (8.77%) 
Agitation  1  3/57 (5.26%) 
Anxiety  1  1/57 (1.75%) 
Depression  1  3/57 (5.26%) 
Personality  1  1/57 (1.75%) 
Renal and urinary disorders   
Cystitis  1  1/57 (1.75%) 
Incontinence urinary  1  2/57 (3.51%) 
Urinary frequency/urgency  1  6/57 (10.53%) 
Urinary retention  1  1/57 (1.75%) 
Reproductive system and breast disorders   
Erectile impotence  1  2/57 (3.51%) 
Gynecomastia  1  2/57 (3.51%) 
Respiratory, thoracic and mediastinal disorders   
Nose, hemorrhage  1  3/57 (5.26%) 
Cough  1  2/57 (3.51%) 
Dyspnea  1  4/57 (7.02%) 
Nasal cavity/paranasal sinus reaction  1  3/57 (5.26%) 
Voice changes/dysarthria  1  1/57 (1.75%) 
Pulmonary/Upper Respiratory-other  1  1/57 (1.75%) 
Skin and subcutaneous tissue disorders   
Sweating  1  2/57 (3.51%) 
Dry skin  1  9/57 (15.79%) 
Alopecia  1  2/57 (3.51%) 
Hyperpigmentation  1  1/57 (1.75%) 
Nail changes  1  5/57 (8.77%) 
Pruritus/itching  1  1/57 (1.75%) 
Rash/desquamation  1  8/57 (14.04%) 
Rash: acne/acneiform  1  1/57 (1.75%) 
Skin-other  1  7/57 (12.28%) 
Vascular disorders   
Hypertension  1  12/57 (21.05%) 
Hypotension  1  1/57 (1.75%) 
Flushing  1  1/57 (1.75%) 
Hot flashes  1  10/57 (17.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Steven Balk
Organization: Beth Israel Deaconess
Phone: 617-735-2065
EMail: sbalk@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Steven Balk, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00673127     History of Changes
Other Study ID Numbers: 04-414
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: July 9, 2013
Results First Posted: April 22, 2015
Last Update Posted: April 22, 2015