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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), August 2008

Sponsored by: UCSF Helen Diller Family Comprehensive Cancer Center
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
Precancerous/Nonmalignant Condition
Prostate Cancer
Drug: dutasteride
Procedure: magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Procedure: questionnaire administration

MedlinePlus related topics:   Cancer    MRI Scans    Prostate Cancer   

Drug Information available for:   Dutasteride   

U.S. FDA Resources

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

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
UCSF Helen Diller Family Comprehensive Cancer Center

Investigators
Investigator:     Mack Roach, MD     UCSF Helen Diller Family Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Responsible Party:   GlaxoSmithkline ( Regulatory Affairs Associate )
Study ID Numbers:   CDR0000596822, UCSF-05551, H7056-26910-03
First Received:   June 27, 2008
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00706966
Health Authority:   Unspecified

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

Study placed in the following topic categories:
Dutasteride
Pathological Conditions, Anatomical
Hypertrophy
Hyperplasia
Genital Neoplasms, Male
Prostatic Diseases
Prostatic Hyperplasia
Precancerous Conditions
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008




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