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

Condition(s) targeted: Nonmalignant Neoplasm; Prostate Cancer

Intervention: dutasteride (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Mack Roach, MD, Principal Investigator, Affiliation: University of California, San Francisco

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.

Official title: A Pilot Study of MRI and Spectroscopy Imaging Changes With 6-months of Dutasteride in Patients With Symptomatic Benign Prostatic Hypertrophy and Low-risk Prostate Cancer on Watchful Waiting or Requiring Neoadjuvant Androgen Suppression Prior to Prostate Brachytherapy

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Change in Extent of Cancer

Secondary outcome:

Adverse Events Indicative of Safety of Dutasteride

Symptom Indices Over Time - IPSS

Symptom Indices Over Time - IIEF-5

Health-Related Quality of Life (HRQL) Indices Over Time - FACE

Health-Related Quality of Life (HRQL) Indices Over Time - SQLI

Total PSA Over Time

Dihydrotestosterone (DHT) Over Time

Testosterone Over Time

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 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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)

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2005
Last updated: December 2, 2013