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Magnetic Resonance Imaging in Evaluating Patients With Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on September 15, 2005.   Last Updated on February 18, 2011   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182624
  Purpose

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help doctors learn the extent of prostate cancer.

PURPOSE: This phase I/II trial is studying how well MRI works in evaluating patients with prostate cancer. (Phase I portion of the study closed to accrual as of February 2005)


Condition Intervention Phase
Prostate Cancer
 Procedure: magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
 Phase I
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Comprehensive Prostate MRI for the Evaluation of Prostate Cancer 3.0T: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer MRI Scans Prostate Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Sensitivity/specificity and test-retest reproducibility of tumor localization on T2-weighted signal ratios (Phase I) [ Designated as safety issue: No ]
  • Sensitivity/specificity and test-retest reproducibility of spectroscopic choline to citrate ratios (Phase I) [ Designated as safety issue: No ]
  • Sensitivity/specificity and test-retest reproducibility of pharmacokinetic modeling parameters after dynamic-enhanced MRI of the prostate (Phase I) [ Designated as safety issue: No ]
  • Sensitivity/specificity and test-retest reproducibility of signal intensity changes on hypoxia maps (Phase I) [ Designated as safety issue: No ]
  • Sensitivity/specificity and test-retest reproducibility of Apparent Diffusion Constant maps (Phase I) [ Designated as safety issue: No ]
  • Sensitivity/specificity and test-retest reproducibility of the overall comprehensive examination (Phase I) [ Designated as safety issue: No ]
  • Histopathological diagnosis (malignant vs benign) within each sextant (Phase II) [ Designated as safety issue: No ]
  • MRI-based diagnosis (malignant vs benign) within each sextant (Phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to acquire the MRI data (Phase I) [ Designated as safety issue: No ]
  • Time to analyze the MRI data and generate a multiparameter tumor map (Phase I) [ Designated as safety issue: No ]
  • Patient feedback on discomfort during the examination using a standard questionnaire (Phase I) [ Designated as safety issue: No ]
  • Volume of cancer by imaging and histology (Phase II) [ Designated as safety issue: No ]
  • Tumor grade (Phase II) [ Designated as safety issue: No ]
  • Prostate-specific antigen (Phase II) [ Designated as safety issue: No ]
  • Genomic and proteomic profiles (Phase II) [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2005
Detailed Description:

OBJECTIVES:

Primary

  • Develop a comprehensive magnetic resonance imaging (MRI) exam that is reproducible, has low diagnostic error, and is tolerated by patients with prostate cancer. (Phase I) (closed to accrual as of February 2005)
  • Determine the appropriate diagnostic criteria for each MRI technique in order to establish interpretative guidelines for the phase II portion of this study in these patients. (Phase I) (closed to accrual as of February 2005)
  • Determine the diagnostic error, sensitivity, and specificity of a comprehensive MRI prostate exam on a region by region basis in these patients. (Phase II)

Secondary

  • Determine the optimal MRI pulse sequences for prostate acquisitions in these patients. (Phase I) (closed to accrual as of February 2005)
  • Determine the tolerability of a comprehensive MRI prostate exam at 3.0 Tesla in these patients. (Phase I) (closed to accrual as of February 2005)
  • Generate overall probability maps of malignancy within the prostate gland in patients undergoing MRI. (Phase I) (closed to accrual as of February 2005)
  • Correlate MRI measurements obtained on different sequences with prostate-specific antigen levels and tumor grade in these patients. (Phase II)
  • Correlate suspicious regions identified by MRI with pathologic findings obtained through biopsy or prostate specimen material in these patients. (Phase II)
  • Compare imaging results with molecular and proteomic profiles of prostate tissue samples co-localized with imaging in these patients. (Phase II)

OUTLINE: This is a pilot, phase I study (closed to accrual as of February 2005) followed by a phase II study.

  • Phase I (closed to accrual as of February 2005): Patients undergo a comprehensive endorectal-coil and surface-phased array MRI of the prostate at 3.0 Tesla comprising high-resolution T2 weighted fast spin echo, MR spectroscopy, hypoxia imaging, diffusion weighted MRI, and dynamic contrast-enhanced MRI. Some patients may undergo repeat MRI.
  • Phase II: Patients undergo a comprehensive endorectal-coil and surface-array MRI of the prostate at 3.0 Tesla that includes some or all of the components performed in the phase I portion of the study. Some patients may also undergo core needle biopsy and/or radical prostatectomy.

PROJECTED ACCRUAL: A total of 80 patients (30 for the phase I portion [closed to accrual as of February 2005] and 50 for the phase II portion) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate by transrectal biopsy

    • Patient must have undergone at least a sextant biopsy and the location of each specimen must be known
  • No distant metastatic disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count ≥ 50,000/mm^3
  • No history of documented bleeding disorder

Hepatic

  • PT/PTT ≤ 1.5 times upper limit of normal

Renal

  • Not specified

Cardiovascular

  • No pacemaker
  • No artificial heart valve
  • No cerebral aneurysm clips

Other

  • Weight ≤ 136 kg
  • No history of documented severe immunocompromise
  • No severe hemorrhoids
  • No shrapnel injury
  • No foreign metal objects within the eye
  • No cochlear implant
  • No other implanted electronic device not compatible with MRI
  • No prior severe adverse event associated with prostatic biopsy
  • No other contraindication to prostatic biopsy or MRI
  • No other contraindication to endorectal coil placement
  • No other medical condition that would preclude study participation
  • No cognitive impairment that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No prior androgen ablative hormonal therapy (e.g., luteinizing hormone-releasing hormone analogues or anti-androgens)

Radiotherapy

  • No prior radiotherapy to the pelvis or prostate

Surgery

  • No prior surgery to remove the rectum
  • No prior orchiectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182624

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter Choyke, MD National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Web site for additional information  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00182624     History of Changes
Obsolete Identifiers: NCT00076908
Other Study ID Numbers: CDR0000439518, NCI-04-CC-0109
Study First Received: September 15, 2005
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
 stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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