Prostate Cancer Clinical Trial
Official title:
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
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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