Trial Outcomes & Findings for Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer (NCT NCT00673127)
NCT ID: NCT00673127
Last Updated: 2015-04-22
Results Overview
PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.
Results posted on
2015-04-22
Participant Flow
Medical oncology clinics
Required 6 week washout for any AR antagonists
Participant milestones
| Measure |
KHAD
KHAD; ketoconazole, hydrocortisone and dutasteride for CRPC
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer
Baseline characteristics by cohort
| Measure |
KHAD
n=57 Participants
Ketoconazole, Hydrocortisone and Dutasteride
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation until treatment cessation. Maximum 32 months. Median treament duration 8 months.PSA decline of 50% from baseline confirmed by a PSA at least 4 weeks later.
Outcome measures
| Measure |
KHAD
n=57 Participants
Ketoconazole, Hydrocortisone and Dutasteride
|
|---|---|
|
PSA Response
|
56 percentage of participants
Interval 42.4 to 69.3
|
SECONDARY outcome
Timeframe: Duration of time from treatment initiation until documented progression. Maximum 32 monthsDuration of time from treatment initiation until documented progression (PSA or Disease progression)
Outcome measures
| Measure |
KHAD
n=57 Participants
Ketoconazole, Hydrocortisone and Dutasteride
|
|---|---|
|
Time to Progression
|
14.5 months
Interval 11.0 to 17.0
|
Adverse Events
KHAD
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KHAD
n=57 participants at risk
Ketoconazole, Hydrocortisone and Dutasteride
|
|---|---|
|
Vascular disorders
grade 4 thrombosis
|
1.8%
1/57 • Number of events 1
|
Other adverse events
| Measure |
KHAD
n=57 participants at risk
Ketoconazole, Hydrocortisone and Dutasteride
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
40.4%
23/57
|
|
Blood and lymphatic system disorders
Hematologic-other
|
1.8%
1/57
|
|
Cardiac disorders
Cardiomyopathy, restrictive
|
1.8%
1/57
|
|
Cardiac disorders
Cardiac-other
|
1.8%
1/57
|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
1/57
|
|
Endocrine disorders
Endocrine-other
|
1.8%
1/57
|
|
Eye disorders
Cataract
|
1.8%
1/57
|
|
Eye disorders
Dry eye syndrome
|
5.3%
3/57
|
|
Eye disorders
Vision-blurred
|
3.5%
2/57
|
|
Eye disorders
Tearing
|
1.8%
1/57
|
|
Eye disorders
Ocular-other
|
3.5%
2/57
|
|
Gastrointestinal disorders
Constipation
|
8.8%
5/57
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
7.0%
4/57
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
1.8%
1/57
|
|
Gastrointestinal disorders
Dry mouth
|
7.0%
4/57
|
|
Gastrointestinal disorders
Esophagitis
|
1.8%
1/57
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/57
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/57
|
|
Gastrointestinal disorders
Dyspepsia
|
10.5%
6/57
|
|
Gastrointestinal disorders
Incontinence, anal
|
1.8%
1/57
|
|
Gastrointestinal disorders
Nausea
|
24.6%
14/57
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
4/57
|
|
Gastrointestinal disorders
GI-other
|
8.8%
5/57
|
|
General disorders
Fatigue
|
36.8%
21/57
|
|
General disorders
Fever w/o neutropenia
|
1.8%
1/57
|
|
General disorders
Constitutional, other
|
10.5%
6/57
|
|
General disorders
Edema head and neck
|
1.8%
1/57
|
|
General disorders
Edema limb
|
17.5%
10/57
|
|
General disorders
Pain-other
|
8.8%
5/57
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
1.8%
1/57
|
|
Infections and infestations
Infection-other
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
Bruising
|
3.5%
2/57
|
|
Investigations
Lymphopenia
|
5.3%
3/57
|
|
Investigations
Weight gain
|
3.5%
2/57
|
|
Investigations
Alkaline phosphatase
|
10.5%
6/57
|
|
Investigations
ALT, SGPT
|
47.4%
27/57
|
|
Investigations
AST, SGOT
|
50.9%
29/57
|
|
Investigations
Bilirubin
|
5.3%
3/57
|
|
Investigations
Creatinine
|
26.3%
15/57
|
|
Investigations
Metabolic/Laboratory-other
|
3.5%
2/57
|
|
Metabolism and nutrition disorders
Pancreatic glucose intolerance
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.8%
21/57
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.0%
4/57
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.5%
2/57
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
6/57
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/57
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.5%
2/57
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
3.5%
2/57
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.8%
1/57
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
1.8%
1/57
|
|
Nervous system disorders
Taste disturbance
|
10.5%
6/57
|
|
Nervous system disorders
Cognitive disturbance
|
1.8%
1/57
|
|
Nervous system disorders
Dizziness
|
3.5%
2/57
|
|
Nervous system disorders
Memory impairment
|
1.8%
1/57
|
|
Nervous system disorders
Neuropathy-sensory
|
1.8%
1/57
|
|
Nervous system disorders
Neurologic-other
|
5.3%
3/57
|
|
Nervous system disorders
Head/headache
|
7.0%
4/57
|
|
Psychiatric disorders
Insomnia
|
8.8%
5/57
|
|
Psychiatric disorders
Agitation
|
5.3%
3/57
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/57
|
|
Psychiatric disorders
Depression
|
5.3%
3/57
|
|
Psychiatric disorders
Personality
|
1.8%
1/57
|
|
Renal and urinary disorders
Cystitis
|
1.8%
1/57
|
|
Renal and urinary disorders
Incontinence urinary
|
3.5%
2/57
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
10.5%
6/57
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
1/57
|
|
Reproductive system and breast disorders
Erectile impotence
|
3.5%
2/57
|
|
Reproductive system and breast disorders
Gynecomastia
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
5.3%
3/57
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
2/57
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.0%
4/57
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
5.3%
3/57
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.5%
2/57
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.8%
9/57
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.5%
2/57
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
8.8%
5/57
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.0%
8/57
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
12.3%
7/57
|
|
Vascular disorders
Hypertension
|
21.1%
12/57
|
|
Vascular disorders
Hypotension
|
1.8%
1/57
|
|
Vascular disorders
Flushing
|
1.8%
1/57
|
|
Vascular disorders
Hot flashes
|
17.5%
10/57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place