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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

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 28, 2009
Results First Submitted Date  ICMJE March 16, 2016
Results First Posted Date  ICMJE April 18, 2016
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2013)
16
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2009)
200
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985738
Other Study ID Numbers  ICMJE 09-0247.cc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Al Barqawi, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP