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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Dutasteride

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)