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Itraconazole in Treating Patients With Biochemically Relapsed Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01787331
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Stage I Prostate Adenocarcinoma AJCC v7
Stage II Prostate Adenocarcinoma AJCC v7
Stage III Prostate Adenocarcinoma AJCC v7
Interventions Drug: Itraconazole
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Itraconazole)
Hide Arm/Group Description Patients receive twice/day 300mg itraconazole (oral)
Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Treatment (Itraconazole)
Hide Arm/Group Description Patients receive twice/day 300mg itraconazole (oral)
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants
40-49 Years 1
50-59 Years 1
60-69 Years 10
70-79 Years 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
0
   0.0%
Male
21
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
2
   9.5%
Not Hispanic or Latino
19
  90.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
20
  95.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Years since diagnosis of prostate cancer  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
7.83
(0.63 to 18.01)
Gleason Grade at Time of Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Gleason grade ≤ 7 (low/intermediate grade)
14
  66.7%
Gleason grade > 7 (high grade)
7
  33.3%
[1]
Measure Description: Gleason grade is determined at the time of diagnosis based on pathology review of prostate cancer biopsy or surgical specimen. A higher Gleason grade (> 7) is associated with a higher chance for disease recurrence and shorter long-term survival.
Time interval from biochemical relapse to study entry  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
4.01
(0.13 to 16.44)
PSA doubling time at the time of study entry  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 21 participants
5.72
(1.16 to 13.05)
1.Primary Outcome
Title Number of Patients Who Achieve a Greater Than or Equal to 50% Decline in Serum Prostate Specific Antigen (PSA)
Hide Description The number of patients with biochemically relapsed disease after prior definitive local therapy who achieve a ≥ 50% decline from baseline in serum PSA after 12 weeks of therapy with itraconazole, confirmed by repeat measurement at least 2 weeks later.
Time Frame At 12 weeks after start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Itraconazole)
Hide Arm/Group Description:
Patients receive twice/day 300mg itraconazole (oral)
Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
2.Secondary Outcome
Title Median Time to PSA Progression
Hide Description

PSA progression defined as:

  1. If no PSA decline is observed on therapy, PSA progression will be defined as an increase in serum PSA > 50% above the baseline PSA, and an absolute increase of > 2 ng/mL above baseline, confirmed by repeat measurement at least 2 weeks later.
  2. If PSA declines on therapy, PSA progression will be defined as an increase in serum PSA > 50% above the nadir PSA on therapy, and an absolute increase > 2 ng/mL above the nadir, confirmed by repeat measurement at least 2 weeks later.

The probability distribution of the time to PSA progression will be estimated using the Kaplan-Meier product limit method measured from the start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.

Time Frame From day 1 of study treatment to the first date of PSA progression, assessed up to 2 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Median Time to Clinical Progression
Hide Description

Clinical progression will be defined as the first occurrence of either the development of metastases or initiation of non-protocol therapy, and will exclude PSA-only progression.

The probability distribution of the time to clinical progression will be estimated using the Kaplan-Meier product limit method measured from the time of start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.

Time Frame From day 1 of protocol therapy to first occurrence of either development of overt metastases or initiation of non-protocol therapy, whichever comes first, assessed up to 2 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Median Metastasis-free Survival
Hide Description The probability distribution of the time to first metastasis will be estimated using the Kaplan-Meier product limit method measured from the time of start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.
Time Frame From the time of start of protocol therapy to development of metastatic disease, assessed up to 2 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Mean Percent Change in PSA Doubling Time
Hide Description The mean percent change in PSA doubling time after 12 weeks of protocol therapy from pre-treatment PSA doubling time.
Time Frame Baseline to up to 12 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients did not make it to week 12
Arm/Group Title Treatment (Itraconazole)
Hide Arm/Group Description:
Patients receive twice/day 300mg itraconazole (oral)
Overall Number of Participants Analyzed 19
Mean (Full Range)
Unit of Measure: Percent change in PSA doubling time
-0.64
(-59.96 to 71.38)
6.Secondary Outcome
Title Adverse Events Observed During Treatment
Hide Description All adverse events will be tabulated by grade according to CTCAE version 4.03. Reported grades will be based on the worst grade experienced by each patient for any given adverse event.
Time Frame Up to 2 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Mean Steady-state Trough Level of Serum Itraconazole
Hide Description Descriptive statistics including the mean, standard deviation, and range of steady-state trough serum levels of itraconazole and its active metabolite hydroxy-itraconazole will be determined.
Time Frame 4 weeks after start of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
test was not performed due to lack of validated assay available
Arm/Group Title Treatment (Itraconazole)
Hide Arm/Group Description:
Patients receive twice/day 300mg itraconazole (oral)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Mean Steady-state Trough Level of Hydroxy-itraconazole
Hide Description [Not Specified]
Time Frame 4 weeks after start of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
test was not performed due to lack of validated assay available
Arm/Group Title Treatment (Itraconazole)
Hide Arm/Group Description:
Patients receive twice/day 300mg itraconazole (oral)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 4 years, 5 months since start of treatment of first patient
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Itraconazole)
Hide Arm/Group Description Patients receive twice/day 300mg itraconazole (oral)
All-Cause Mortality
Treatment (Itraconazole)
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Itraconazole)
Affected / at Risk (%)
Total   2/21 (9.52%) 
Cardiac disorders   
Atrial flutter   1/21 (4.76%) 
Infections and infestations   
Lung infection   1/21 (4.76%) 
Sepsis   1/21 (4.76%) 
Investigations   
Investigations - Other, specify   1/21 (4.76%) 
Renal and urinary disorders   
Renal and urinary disorders - Other, specify   1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary edema   1/21 (4.76%) 
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%
Treatment (Itraconazole)
Affected / at Risk (%)
Total   21/21 (100.00%) 
Cardiac disorders   
Atrial flutter   1/21 (4.76%) 
Chest pain - cardiac   1/21 (4.76%) 
Heart failure   1/21 (4.76%) 
Sinus bradycardia   1/21 (4.76%) 
Endocrine disorders   
Adrenal insufficiency   1/21 (4.76%) 
Gastrointestinal disorders   
Constipation   3/21 (14.29%) 
Diarrhea   3/21 (14.29%) 
Nausea   3/21 (14.29%) 
Abdominal pain   2/21 (9.52%) 
Dry mouth   2/21 (9.52%) 
Gastroesophageal reflux disease   2/21 (9.52%) 
Abdominal distension   1/21 (4.76%) 
Bloating   1/21 (4.76%) 
Flatulence   1/21 (4.76%) 
Gastrointestinal disorders - Other, specify   1/21 (4.76%) 
General disorders   
Edema limbs   12/21 (57.14%) 
Fatigue   9/21 (42.86%) 
Gait disturbance   1/21 (4.76%) 
General disorders and administration site conditions - Other, specify   1/21 (4.76%) 
Non-cardiac chest pain   1/21 (4.76%) 
Hepatobiliary disorders   
Hepatobiliary disorders - Other, specify   1/21 (4.76%) 
Infections and infestations   
Upper respiratory infection   5/21 (23.81%) 
Rhinitis infective   1/21 (4.76%) 
Urinary tract infection   1/21 (4.76%) 
Investigations   
Alanine aminotransferase increased   5/21 (23.81%) 
Aspartate aminotransferase increased   4/21 (19.05%) 
Blood bilirubin increased   1/21 (4.76%) 
Lymphocyte count decreased   1/21 (4.76%) 
Neutrophil count decreased   1/21 (4.76%) 
Weight loss   1/21 (4.76%) 
White blood cell decreased   1/21 (4.76%) 
Metabolism and nutrition disorders   
Hypokalemia   6/21 (28.57%) 
Anorexia   2/21 (9.52%) 
Hyperglycemia   1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity   2/21 (9.52%) 
Generalized muscle weakness   1/21 (4.76%) 
Muscle weakness lower limb   1/21 (4.76%) 
Nervous system disorders   
Dizziness   4/21 (19.05%) 
Headache   2/21 (9.52%) 
Cognitive disturbance   1/21 (4.76%) 
Dysgeusia   1/21 (4.76%) 
Paresthesia   1/21 (4.76%) 
Psychiatric disorders   
Depression   1/21 (4.76%) 
Libido decreased   1/21 (4.76%) 
Renal and urinary disorders   
Urinary frequency   1/21 (4.76%) 
Urinary incontinence   1/21 (4.76%) 
Reproductive system and breast disorders   
Erectile dysfunction   1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   4/21 (19.05%) 
Cough   1/21 (4.76%) 
Hoarseness   1/21 (4.76%) 
Nasal congestion   1/21 (4.76%) 
Sinus disorder   1/21 (4.76%) 
Sore throat   1/21 (4.76%) 
Wheezing   1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Dry skin   2/21 (9.52%) 
Rash maculo-papular   2/21 (9.52%) 
Nail ridging   1/21 (4.76%) 
Photosensitivity   1/21 (4.76%) 
Skin and subcutaneous tissue disorders - Other, specify   1/21 (4.76%) 
Vascular disorders   
Hypertension   6/21 (28.57%) 
Hot flashes   1/21 (4.76%) 
Lymphedema   1/21 (4.76%) 
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: Rahul Aggarwal, MD
Organization: University of California, San Francisco
Phone: 877-827-3222
EMail: clinicaltrials@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01787331     History of Changes
Other Study ID Numbers: 125513
NCI-2013-02375 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: February 6, 2013
First Posted: February 8, 2013
Results First Submitted: June 1, 2018
Results First Posted: October 23, 2018
Last Update Posted: October 23, 2018