Expired Study
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San Francisco, California 94115


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.


Study summary:

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.


Criteria:

Inclusion criteria: - Histologically confirmed adenocarcinoma of the prostate - Clinical stage T1b, T1c, or T2a disease - Gleason score ≤ 6 - Maximal prostate-specific antigen (PSA) < 10 ng/mL - Demonstrates intra-prostatic metabolite abnormalities, consistent with adenocarcinoma of the prostate (i.e., ≥ 3 voxels with magnetic resonance spectroscopy imaging [MRSI] scores 4-5) by baseline MRI and MRSI - Has symptomatic benign prostatic hypertrophy and is currently undergoing watchful waiting OR opting to undergo permanent seed implant (i.e., brachytherapy), but requires neoadjuvant androgen suppression for prostate shrinkage - No regional lymph node involvement - No evidence of distant metastases - Zubrod performance status 0-1 - Able to swallow and retain oral medications Exclusion Criteria: - Other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin - Contraindications to MRI/MRSI, including any of the following: - Prostate biopsy (within the past 8 weeks) and any continued post-biopsy bleeding - Rectal bleeding - Anal fissures - Rectal surgery (end-to-end anastomosis) - Inflammatory bowel disease - Prior radical prostatectomy - Hip replacement - Certain types of penile implants - Vascular clips - Known anaphylactic reaction to latex compounds - Anticoagulant drugs - Severe claustrophobia - Cardiac pacemaker - Metal in eye - Any other metallic or foreign object in the body - Unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident - Major medical or psychiatric illness that, in the investigator's opinion, would preclude the completion of treatment and interfere with follow up - Known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug - Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer - Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy - Prior or concurrent cytotoxic chemotherapy for prostate cancer - Prior hormonal therapy, such as luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide acetate), antiandrogens (e.g., flutamide or bicalutamide), or estrogens (e.g., diethylstilbestrol) - Prior or concurrent finasteride, dutasteride, other drugs with known antiandrogenic properties (e.g., spironolactone or progestational agents), or any dietary or herbal supplement (e.g., selenium, vitamin E, saw palmetto, or PC-SPES)


NCT ID:

NCT00706966


Primary Contact:

Principal Investigator
Mack Roach, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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