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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00706966 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Nonmalignant Neoplasm Prostate Cancer |
Drug: dutasteride Other: questionnaire administration Other: watchful waiting Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Procedure: neoadjuvant therapy Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Diagnostic |
| 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 |
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2005 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
PATIENT CHARACTERISTICS:
No contraindications to MRI/MRSI, including any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Mack Roach, MD 415-353-9855 tdiep@radonc.ucsf.edu | |
| Investigator: | Mack Roach, MD | University of California, San Francisco |
More Information
| Responsible Party: | GlaxoSmithkline ( Regulatory Affairs Associate ) |
| Study ID Numbers: | CDR0000596822, UCSF-05551, H7056-26910-03 |
| Study First Received: | June 27, 2008 |
| Last Updated: | January 28, 2010 |
| ClinicalTrials.gov Identifier: | NCT00706966 History of Changes |
| Health Authority: | Unspecified |
|
adenocarcinoma of the prostate stage II prostate cancer benign prostatic hyperplasia |
|
Pathological Conditions, Anatomical Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Enzyme Inhibitors Genital Diseases, Male |
Pharmacologic Actions Dutasteride Neoplasms Hypertrophy Neoplasms by Site Prostatic Hyperplasia Prostatic Neoplasms |