mri and magnetic resonance spectroscopy imaging in patients receiving dutasteride for benign prostatic hypertrophy and low-risk prostate cancer

Conditions: Nonmalignant Neoplasm; Prostate Cancer

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.

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.

Eligibility 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)

Keywords: adenocarcinoma of the prostate stage iib prostate cancer stage iia prostate cancer benign prostatic hyperplasia