MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer

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)