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Trial record 5 of 117 for:    DUTASTERIDE

Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00985738
Recruitment Status : Terminated (Low recruitment)
First Posted : September 28, 2009
Results First Posted : April 18, 2016
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Dutasteride
Other: Placebo
Enrollment 16
Recruitment Details Between 2009 and 2011, 16 patients were enrolled in the study from the Urologic Oncology clinic and Outpatient Urology clinic.
Pre-assignment Details Subjects who qualified for the study based on the eligibility criteria were randomized to a placebo or treatment arm. After approximately 90 days (± 10 days), patients returned to undergo 3D mapping biopsy as part of their management of prostate cancer and received the tests/procedures outlined in the study calendar.
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy. This group received a placebo followed by 3D mapping biopsy.
Period Title: Overall Study
Started 8 8
Completed 0 0
Not Completed 8 8
Reason Not Completed
Study closed prematurely             8             8
Arm/Group Title Dutasteride Placebo Total
Hide Arm/Group Description Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy. This group received a placebo followed by 3D mapping biopsy. Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
A one sided test of proportions with an alpha level of 0.025 was performed for a conservative Fisher’s exact method. It was estimated that an 80% power in a test of proportions with 100 men in each arm would detect a 17% difference in proportion of men with increased tumor volume (upstaging) between the treatment arm and the control arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  62.5%
4
  50.0%
9
  56.3%
>=65 years
3
  37.5%
4
  50.0%
7
  43.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 16 participants
63.5  (6.0) 65.8  (6.3) 64.4  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
8
 100.0%
16
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
8
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  37.5%
2
  25.0%
5
  31.3%
White
5
  62.5%
6
  75.0%
11
  68.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.
Hide Description The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
"The study was terminated. Study end points were not reached. No data were collected
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description:
Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
This group received a placebo followed by 3D mapping biopsy.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were collected for 27 months.
Adverse Event Reporting Description Adverse events were monitored throughout the course of the study and 3-months as a follow up period.
 
Arm/Group Title Dutasteride Placebo
Hide Arm/Group Description Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy. This group received a placebo followed by 3D mapping biopsy.
All-Cause Mortality
Dutasteride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dutasteride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dutasteride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
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: Dr. Al Baha Barqawi
Organization: University of Colorado Hospital
Phone: 303-724-2722
EMail: AL.BARQAWI@UCDENVER.EDU
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00985738     History of Changes
Other Study ID Numbers: 09-0247.cc
First Submitted: September 11, 2009
First Posted: September 28, 2009
Results First Submitted: March 16, 2016
Results First Posted: April 18, 2016
Last Update Posted: May 17, 2016