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

Completed · Not applicable

Conditions studied: Nonmalignant Neoplasm, Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00706966

Run by

University of California, San Francisco

People needed

10

Starts

2005-06-01

Expected to finish

2011-08-01

Last updated by the study team

2014-01-17

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.