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

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

Tracking Information

• First Submitted Date: September 11, 2009
• First Posted Date: September 28, 2009
• Results First Submitted Date: March 16, 2016
• Results First Posted Date: April 18, 2016
• Last Update Posted Date: May 17, 2016
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 16, 2016)

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. [ Time Frame: 24 Months ]

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.

• Original Primary Outcome Measures (submitted: September 25, 2009): 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. [ Time Frame: 24 Months ]
• Change History: Complete list of historical versions of study NCT00985738 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: September 25, 2009): To determine the effect of daily intake of Dutasteride 0.5 mg (90 days) on prostate volume and total PSA level in patients with prostate size >15 grams before undergoing 3D mapping biopsy. [ Time Frame: 24 Months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Drug: Dutasteride
  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.
  Other Name: Avodart
• Other: Placebo
  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.

Study Arms

• Experimental: Dutasteride
  The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.
  Intervention: Drug: Dutasteride
• Placebo Comparator: Placebo
  The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 15, 2013): 16
• Original Estimated Enrollment (submitted: September 25, 2009): 200
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00985738
• Other Study ID Numbers: 09-0247.cc
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Colorado, Denver
• Study Sponsor: University of Colorado, Denver
• Collaborators: GlaxoSmithKline

Investigators

• Principal Investigator: Al Barqawi, MD; University of Colorado, Denver

• PRS Account: University of Colorado, Denver
• Verification Date: March 2016