Trials / Completed
CompletedNCT00706966
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
A Pilot Study of MRI and Spectroscopy Imaging Changes With 6-months of Dutasteride in Patients With Symptomatic Benign Prostatic Hypertrophy and Low-risk Prostate Cancer on Watchful Waiting or Requiring Neoadjuvant Androgen Suppression Prior to Prostate Brachytherapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Diagnostic procedures, such as MRI and magnetic resonance spectroscopy imaging, may help in learning how well dutasteride works in patients with benign prostatic hypertrophy and low-risk prostate cancer. PURPOSE: This clinical trial is studying MRI and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer.
Detailed description
OBJECTIVES: Primary * To determine whether there is a decrease in the extent of prostate cancer as measured by endorectal MRI and magnetic resonance spectroscopy imaging in patients with symptomatic benign prostatic hypertrophy and low-risk prostate cancer treated with dutasteride for 6 months. Secondary * To monitor the effects of dutasteride on serum testosterone, dihydrotestosterone, and free and total prostate-specific antigen (PSA). * To monitor the effects of dutasteride on symptom and quality-of-life indices. OUTLINE: Patients receive oral dutasteride once daily for 6 months. Patients undergo endorectal MRI and magnetic resonance spectroscopy imaging at baseline and at 1, 3, and 6 months. Patients complete quality-of-life questionnaires using the International Index of Erectile Function Questionnaire, American Urological Association Symptom Index, Functional Alterations due to Changes in Elimination, and Spitzer Quality-of-Life Index at baseline and at 1, 3, and 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dutasteride | 6 months of dutasteride 3.5 mg daily |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2008-12-01
- Completion
- 2011-08-01
- First posted
- 2008-06-30
- Last updated
- 2014-01-17
- Results posted
- 2014-01-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00706966. Inclusion in this directory is not an endorsement.