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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dutasteride
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Early Stage Prostate Cancer

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 40-85 year old males
  • Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores.
  • Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management.
  • Patient will read, understand and sign the informed consent agreement
  • Patients must have a life expectancy of at least one year.
  • Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4
  • Percentage positive core rate < 50% based on sextant or extended biopsy technique.
  • Prostate Volume (PV) >15 grams.
  • Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA> 10 ng.dl before initiation of the study drug

Exclusion Criteria:

  • Any 5α-reductase inhibitors medications within the past 12 months before enrollment.
  • Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors.
  • Anticipated blood donation within the next 90 days.
  • Serum PSA levels of >20ng/dl.
  • Clinical evidence of metastatic prostate cancer.
  • Two documented urinary tract infections in the past year
  • CHF, MI (within 6 months) or other symptomatic CVS disease
  • Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric)
  • Enrollment in other studies for any disease in the past 30 days
  • Significant urinary incontinence
  • Diagnosis of cancer that in not considered cured, except BCC of skin
  • Prior transurethral resection of the prostate with a large tissue defect.
  • History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
  • Previous or concurrent radiotherapy, hormonal therapy or chemotherapy

Sites / Locations

  • University of Colorado Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dutasteride

Placebo

Arm Description

The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.

The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2009
Last Updated
April 15, 2016
Sponsor
University of Colorado, Denver
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00985738
Brief Title
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
Official Title
A Randomized Placebo-Controlled Double-Blind Clinical Trial to Assess the Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.
Detailed Description
This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Early Stage Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dutasteride
Arm Type
Experimental
Arm Description
The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.
Intervention Type
Drug
Intervention Name(s)
Dutasteride
Other Intervention Name(s)
Avodart
Intervention Description
Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.
Primary Outcome Measure Information:
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.
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40-85 year old males Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores. Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management. Patient will read, understand and sign the informed consent agreement Patients must have a life expectancy of at least one year. Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4 Percentage positive core rate < 50% based on sextant or extended biopsy technique. Prostate Volume (PV) >15 grams. Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA> 10 ng.dl before initiation of the study drug Exclusion Criteria: Any 5α-reductase inhibitors medications within the past 12 months before enrollment. Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors. Anticipated blood donation within the next 90 days. Serum PSA levels of >20ng/dl. Clinical evidence of metastatic prostate cancer. Two documented urinary tract infections in the past year CHF, MI (within 6 months) or other symptomatic CVS disease Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric) Enrollment in other studies for any disease in the past 30 days Significant urinary incontinence Diagnosis of cancer that in not considered cured, except BCC of skin Prior transurethral resection of the prostate with a large tissue defect. History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology Previous or concurrent radiotherapy, hormonal therapy or chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al Barqawi, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.alprostate.com
Description
The link above provides detail about the Primary Investigator (PI- Al Barqawi MD FRCS) and his research on prostate cancer. In addition, this website includes the PI's resume and publications.

Learn more about this trial

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

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