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Trial record 11 of 118 for:    DUTASTERIDE

MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk 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: NCT00706966
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : January 17, 2014
Last Update Posted : January 17, 2014
Sponsor:
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: Diagnostic
Conditions Nonmalignant Neoplasm
Prostate Cancer
Intervention Drug: dutasteride
Enrollment 10
Recruitment Details Patients were recruited from June 2005 to June 2008 from untreated patients seen at the University of California San Francisco
Pre-assignment Details  
Arm/Group Title Dutasteride
Hide Arm/Group Description

Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months

dutasteride : 6 months of dutasteride 3.5 mg daily

Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Dutasteride
Hide Arm/Group Description

Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months

dutasteride : 6 months of dutasteride 3.5 mg daily

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
65
(57 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Clinical Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
T1c 7
T2a 3
[1]
Measure Description: In the TNM system, T refers to the primary prostate tumor, N refers to the status of the lymph nodes near to the prostate, and M refers to the degree to which prostate cancer has traveled out of the immediate area of the prostate to other organs of the body (metastases). T1c = a positive prostate specific antigen (PSA) test but no other clinical sign of the disease (i.e., no abnormality felt on digital rectal examination or visible on any form of imaging test). T2a = tumor is palpable or visible on imaging (ultrasound or MRI) in not more than half of one side (one lobe) of the prostate.
Total PSA   [1] 
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 10 participants
5.05
(2.14 to 11.74)
[1]
Measure Description: The prostate-specific antigen (PSA) test measures the blood level of PSA, a protein that is produced by the prostate gland.
Prostate volume   [1] 
Mean (Full Range)
Unit of measure:  mL
Number Analyzed 10 participants
47.3
(22.0 to 75.2)
[1]
Measure Description: To assess prostate volume, regions of interest were manually drawn around the prostate across its full three-dimensional extent on the T2-weighted MR images; at subsequent timepoints, prostate volume was assessed as a percentage of the baseline value.
1.Primary Outcome
Title Change in Extent of Cancer
Hide Description Proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging (MRSI). MRSI spectra were examined and scored as healthy or cancerous. The change in cancerous volumes over time was evaluated. Because a significant decrease in citrate and polyamines on MRSI spectra was noted at 1 month compared with baseline, healthy tissue appeared to be more like cancer and thus created a false impression that the cancer had grown after 1 month. To reduce this bias, primary comparisons were made between the 1-month and 6-month scans.
Time Frame 1 month, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew from the study
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months

dutasteride : 6 months of dutasteride 3.5 mg daily

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
30-45% Decrease 3
No change (95 - 100%) 2
65-167% Increase 4
2.Secondary Outcome
Title Adverse Events Indicative of Safety of Dutasteride
Hide Description Toxicities from Dutasteride were recorded at each study visit and assessed by NCI-CTCAE v3.0.
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dutasteride
Hide Arm/Group Description:

Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months

dutasteride : 6 months of dutasteride 3.5 mg daily

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: adverse events
5
3.Secondary Outcome
Title Symptom Indices Over Time - IPSS
Hide Description IPSS (The International Prostate Symptom Score) is a symptom index based on seven questions concerning urinary symptoms (1 Incomplete emptying, 2 Frequency, 3 Intermittency, 4 Urgency, 5 Weak Stream, 6 Straining, 7 Nocturia) for which the patient chooses one out of six answers indicating increasing severity of the particular symptom, ranging from 0 (Not at all) to 5(Almost always). The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7); Moderate (symptom score range 8-19); Severe (symptom score range 20-35).
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.
Arm/Group Title Dutasteride - Baseline Dutasteride - 1 Month Dutasteride - 3 Months Dutasteride - 6 Months
Hide Arm/Group Description:
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at Baseline.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 1 month.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 3 months.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IPSS was assessed at 6 months.
Overall Number of Participants Analyzed 10 10 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.8  (3.8) 6.6  (3.0) 7.9  (4.4) 5.9  (4.3)
4.Secondary Outcome
Title Symptom Indices Over Time - IIEF-5
Hide Description The International Index of Erectile Function (IIEF-5) is an abridged five-item version of the original IIEF 15-item questionnaire designed to evaluate erectile function, based on a definition arrived at by the National Institutes of Health Consensus Panel. Each of 5 questions about erectile function over the past 6 months is scored by the patient from 1 (severe dysfunction) to 5 (little or no dysfunction). The IIEF-5 is scored from 5 to 25, with lower scores indicating erectile dysfunction: 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.
Arm/Group Title Dutasteride - Baseline Dutasteride - 1 Month Dutasteride - 3 Months Dutasteride - 6 Months
Hide Arm/Group Description:
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at baseline.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 1 month.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 3 months.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. IIEF-5 was assessed at 6 months.
Overall Number of Participants Analyzed 10 10 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.4  (7.8) 17.0  (8.7) 16.0  (7.9) 15.3  (8.6)
5.Secondary Outcome
Title Health-Related Quality of Life (HRQL) Indices Over Time - FACE
Hide Description Functional Alterations due to Changes in Elimination (FACE) is a 14-item questionnaire designed to evaluate the effects of changes in urinary and bowel elimination on daily functioning. It is scored out of 56, with higher scores reflecting poorer HRQL.
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew from the study prior to the 6 month timepoint; thus n=9 at 6 months.
Arm/Group Title Dutasteride - Baseline Dutasteride - 1 Month Dutasteride - 3 Months Dutasteride - 6 Months
Hide Arm/Group Description:
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at Baseline.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 1 month.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 3 months.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. FACE was assessed at 6 months.
Overall Number of Participants Analyzed 10 10 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.6  (2.5) 4.7  (1.2) 5.0  (1.9) 4.8  (1.3)
6.Secondary Outcome
Title Health-Related Quality of Life (HRQL) Indices Over Time - SQLI
Hide Description The Spitzer Quality of Life Index (SQLI) is a validated five-item questionnaire evaluating global HRQL. Activity, daily living, health, support of family and friends, and outlook are each rated on a 3-point scale (0 to 2), with total score ranging from 0-10, with lower score indicating poorer HRQL.
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew from the study prior to 6 months; thus, n=9 at 6 months.
Arm/Group Title Dutasteride - Baseline Dutasteride - 1 Month Dutasteride - 3 Months Dutasteride - 6 Months
Hide Arm/Group Description:
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at Baseline.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 1 month.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 3 months.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. SQLI was assessed at 6 months.
Overall Number of Participants Analyzed 10 10 10 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.7  (0.7) 9.9  (0.3) 9.6  (0.7) 9.9  (0.3)
7.Secondary Outcome
Title Total PSA Over Time
Hide Description [Not Specified]
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Because one participant withdrew from the study prior to 6-months, n=9 for the 6-month Mean(SD) levels.
Arm/Group Title Dutasteride - Baseline Dutasteride - 1 Month Dutasteride - 3 Months Dutasteride - 6 Months
Hide Arm/Group Description:
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at Baseline.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 1 month.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 3 months.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. PSA was measured at 6 months.
Overall Number of Participants Analyzed 10 10 10 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
5.44  (2.90) 4.33  (2.23) 2.85  (1.49) 2.59  (1.06)
8.Secondary Outcome
Title Dihydrotestosterone (DHT) Over Time
Hide Description [Not Specified]
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.
Arm/Group Title Dutasteride - Baseline Dutasteride - 1 Month Dutasteride - 3 Months Dutasteride - 6 Months
Hide Arm/Group Description:
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at Baseline.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 1 month.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 3 months.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. DHT was measured at 6 months.
Overall Number of Participants Analyzed 10 10 10 9
Mean (Standard Deviation)
Unit of Measure: ng/dL
33.5  (8.9) 5.2  (5.5) 2.5  (0.8) 2.5  (0.8)
9.Secondary Outcome
Title Testosterone Over Time
Hide Description [Not Specified]
Time Frame Baseline, 1, 3, and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Because one participant withdrew from the study prior to 6-months, n=9 at 6 months.
Arm/Group Title Dutasteride - Baseline Dutasteride - 1 Month Dutasteride - 3 Months Dutasteride - 6 Months
Hide Arm/Group Description:
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at Baseline.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 1 month.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 3 months.
Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months. Testosterone was measured at 6 months.
Overall Number of Participants Analyzed 10 10 10 9
Mean (Standard Deviation)
Unit of Measure: ng/dL
356.5  (109.3) 418.4  (155.7) 443.2  (132.1) 484.3  (106.0)
Time Frame 6 months
Adverse Event Reporting Description Toxicities from dutasteride were recorded at each follow-up visit using the National Cancer Institute's Common Terminology Criteria for Adverse Events toxicity scale version 3.0
 
Arm/Group Title Dutasteride
Hide Arm/Group Description

Dutasteride was administered at a dose of 3.5 mg as an oral soft gelatin capsule once daily for 6 months

dutasteride: 6 months of dutasteride 3.5 mg daily

All-Cause Mortality
Dutasteride
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Dutasteride
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Dutasteride
Affected / at Risk (%) # Events
Total   4/10 (40.00%)    
Reproductive system and breast disorders   
Decreased ejaculate volume  1  3/10 (30.00%)  3
Skin and subcutaneous tissue disorders   
Rash  1  1/10 (10.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE
The inclusion of only men with low volume disease may have limited our ability to accurately assess response rates after dutasteride due to the background effects on normal prostate metabolism.
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: Mack Roach, MD
Organization: University of California San Francisco
Phone: 415-353-9855
EMail: tdiep@radonc.ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00706966    
Other Study ID Numbers: CDR0000596822
UCSF-05551 ( Other Identifier: UCSF )
H7056-26910-03 ( Other Identifier: Committee on Human Research (CHR) )
First Submitted: June 27, 2008
First Posted: June 30, 2008
Results First Submitted: December 2, 2013
Results First Posted: January 17, 2014
Last Update Posted: January 17, 2014