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MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
First Received: June 27, 2008   Last Updated: January 28, 2010   History of Changes
Sponsor: University of California, San Francisco
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00706966
  Purpose

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.


Condition Intervention
Nonmalignant Neoplasm
Prostate Cancer
Drug: dutasteride
Other: questionnaire administration
Other: watchful waiting
Procedure: magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of dutasteride as assessed by NCI-CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Temporal and magnitude of change in serum-free and total prostate-specific antigen (PSA), dihydrotestosterone, and testosterone [ Designated as safety issue: No ]
  • Symptom and quality-of-life indices [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2005
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706966

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Mack Roach, MD     415-353-9855     tdiep@radonc.ucsf.edu    
Sponsors and Collaborators
University of California, San Francisco
Investigators
Investigator: Mack Roach, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: GlaxoSmithkline ( Regulatory Affairs Associate )
Study ID Numbers: CDR0000596822, UCSF-05551, H7056-26910-03
Study First Received: June 27, 2008
Last Updated: January 28, 2010
ClinicalTrials.gov Identifier: NCT00706966     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage II prostate cancer
benign prostatic hyperplasia

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Urogenital Neoplasms
Enzyme Inhibitors
Genital Diseases, Male
Pharmacologic Actions
Dutasteride
Neoplasms
Hypertrophy
Neoplasms by Site
Prostatic Hyperplasia
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010