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

University of California San Francisco (UCSF)

Status

Completed

Conditions

Nonmalignant Neoplasm

Prostate Cancer

Treatments

Drug: dutasteride

Study type

Interventional

Funder types

Other

Identifiers

NCT00706966

UCSF-05551 (Other Identifier)

H7056-26910-03 (Other Identifier)

CDR0000596822

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

10 patients

Sex

Male

Volunteers

No Healthy Volunteers

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)