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

This study has been terminated.
(low recruitment)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00985738
First received: September 11, 2009
Last updated: January 15, 2013
Last verified: September 2009
  Purpose

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 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.


Condition Intervention Phase
Prostate Cancer
Drug: Dutasteride
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dutasteride
Dutasteride (Avodart) 0.5 mg QD. Drug initiation 3 months before 3 D mapping biopsy.
Drug: Dutasteride
Dutasteride (Avodart) 0.5 mg QD. Drug initiation 3 months before 3 D mapping biopsy.
Placebo Comparator: placebo
placebo
Other: placebo

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985738

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
GlaxoSmithKline
Investigators
Principal Investigator: Al Barqawi, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00985738     History of Changes
Other Study ID Numbers: 09-0247
Study First Received: September 11, 2009
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Prostate Cancer
Early Stage Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014