Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

Primary

1. 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

1. To monitor the effects of dutasteride on serum testosterone, dihydrotestosterone, and free and total prostate-specific antigen (PSA).
2. To monitor the effects of dutasteride on symptom and quality-of-life indices.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• See Patient Characteristics
• No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
• No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
• No prior or concurrent cytotoxic chemotherapy for prostate cancer
• No 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)
• No 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)

Patient Characteristics:

• Zubrod performance status 0-1
• Able to swallow and retain oral medications
• No other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin
• No 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
• No unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident
• No major medical or psychiatric illness that, in the investigator’s opinion, would preclude the completion of treatment and interfere with follow up
• No known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug

Expected Enrollment

Outcomes

Decrease of ≥ 50% in the proportion of voxels consistent with prostate cancer as measured by magnetic resonance spectroscopy imaging at baseline and at 6 months

Safety of dutasteride as assessed by NCI-CTCAE v3.0
Temporal and magnitude of change in serum-free and total prostate-specific antigen (PSA), dihydrotestosterone, and testosterone
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.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

Mack Roach, MD, Research coordinator		Ph: 415-353-9855 Email: tdiep@radonc.ucsf.edu

U.S.A.
California
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Mack Roach, MD	Ph:  415-353-9855
			Email: tdiep@radonc.ucsf.edu

Registry Information
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
Trial Start Date		2005-06-01
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00706966
Date Submitted to PDQ		2008-06-02
Information Last Verified		2008-12-14
NCI Grant/Contract Number		CA93373

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