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Trial Outcomes & Findings for Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer (NCT NCT00985738)

NCT ID: NCT00985738

Last Updated: 2016-05-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

24 Months

Results posted on

2016-05-17

Participant Flow

Between 2009 and 2011, 16 patients were enrolled in the study from the Urologic Oncology clinic and Outpatient Urology clinic.

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.

Participant milestones

Participant milestones
Measure
Dutasteride
Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
Placebo
This group received a placebo followed by 3D mapping biopsy.
Overall Study
STARTED
8
8
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
8
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Dutasteride
Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
Placebo
This group received a placebo followed by 3D mapping biopsy.
Overall Study
Study closed prematurely
8
8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dutasteride
n=8 Participants
Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
Placebo
n=8 Participants
This group received a placebo followed by 3D mapping biopsy.
Total
n=16 Participants
Total of all reporting groups
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
6 Participants
n=7 Participants
11 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
8 Participants
n=5 Participants
8 Participants
n=7 Participants
16 Participants
n=5 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Age, Continuous
63.5 Years
STANDARD_DEVIATION 6.0 • n=5 Participants
65.8 Years
STANDARD_DEVIATION 6.3 • n=7 Participants
64.4 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
8 Participants
n=7 Participants
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=5 Participants
8 Participants
n=7 Participants
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: "The study was terminated. Study end points were not reached. No data were collected

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.

Outcome measures

Outcome data not reported

Adverse Events

Dutasteride

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Al Baha Barqawi

University of Colorado Hospital

Phone: 303-724-2722

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place