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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


Phase 2
40 Years
85 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

24 Months

Safety Issue:

Yes

Principal Investigator

Al Barqawi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

09-0247

NCT ID:

NCT00985738

Start Date:

September 2009

Completion Date:

January 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Early Stage Prostate Cancer
  • Prostatic Neoplasms

Name

Location

University of Colorado HospitalDenver, Colorado  80262