Status:
COMPLETED
MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
Lead Sponsor:
University of California, San Francisco
Conditions:
Nonmalignant Neoplasm
Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief 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 pr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00706966
Start Date
June 1 2005
End Date
August 1 2011
Last Update
January 17 2014
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115