Characterization of Prostate Cancer With 3T MR

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00831142
Collaborator
National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH)
236
1
192
1.2

Study Details

Study Description

Brief Summary

The long-term goal of this proposal is to provide a pre-treatment evaluation that can assist in the rational selection of patients to undergo appropriate and definitive therapy for prostate cancer. In so doing, it may be possible to further improve the numbers and percentage of cancer patients who receive effective therapy that will cure the disease and maximize their quality of life following therapy.

  • Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.

  • Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.

  • Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In our laboratory we have combined the use of new 3T clinical magnetic resonance (MR) technology, dynamic-contrast enhancement (DCE), and a unique endorectal-coil (ERC) probe in order to non-invasively obtain images of the prostate gland with higher signal-to-noise resolution and better spectral dispersion than has been previously achieved. This imaging strategy acquires higher-resolution images with smaller voxel sizes than has been possible with prior MR technology and more comprehensive tissue sampling compared to other pre-surgical assessments. This methodology should make it feasible to assess prostate-tissue morphology and additional features of prostate cancer such as tissue metabolism, tissue kinetics, and the vascular microenvironment, and thus provide a non-invasive tool to: 1) detect extra-capsular spread, 2) detect specific areas within the prostate that harbor cancer, 3) determine the aggressiveness of the cancer and 4) direct biopsy and treatment specifically to diseased areas.

    In order to prospectively validate these goals we will recruit successive patients who have been scheduled for prostate removal to participate to our protocol. Each patient will be studied with an ERC MRI at 3T using T2-weighted (T2W) imaging, DCE 3D T1-weighted imaging and MR spectroscopy (MRS). A pathologist using whole mount preparations will independently analyze each patient's prostate specimen. The whole mount data will be used as the standard against which we will compare the observations and data obtained from the 3T MRI findings.

    Aim 1: To evaluate the accuracy of T2W MRI, DCE-MRI and their combined data for staging prostate cancer.

    Supplementing T2W imaging with the high-resolution capability of 3TMR, we will apply standard morphologic criteria used at 1.5T to determine the presence or absence of extracapsular extension (ECE) of disease. The possible incremental value of high spatial resolution, dynamic contrast-enhanced data will be investigated. MRI results will be compared to ECE determination at whole-mount pathology.

    Aim 2: To evaluate the accuracy of MRI in determining tumor volume in the prostate gland.

    Using dynamic-contrast enhanced MRI with parametric analyses and T2-weighted images, both at smaller voxel sizes than have been used previously, will be our approach. Tumor volumes determined with MRI will be compared to those determined at pathology.

    Aim 3: To evaluate the accuracy of MRI in grading prostate cancer.

    The enhanced resolution available at 3T offers new opportunities to compare Gleason grades with independent and combined assessments of tissue kinetics and metabolism. Pixel by pixel parametric analyses will be obtained. Furthermore, choline to citrate and choline plus creatine to citrate ratios determined using MRS techniques will be obtained. Single voxel techniques will first be employed, followed by 3D chemical shift imaging, when the latter becomes available at 3T. DCE and MRS data will be compared both separately and in combination to the histologic Gleason scores of the comparable tumor identified at whole mount pathology.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    236 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Characterization of Prostate Cancer With 3T MR
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    Jan 1, 2012
    Anticipated Study Completion Date :
    May 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Prostate Cancer

    Males with prostate cancer, referred for biopsy or radical prostatectomy

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      40 Years and Older
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      No

      Inclusion Criteria

      1. Biopsy-proven adenocarcinoma of the prostate.

      2. Written documentation from the urologist stating the anticipation that the patient will undergo radical prostatectomy or biopsy of the prostate within six months of MRI.

      3. The interval between biopsy and protocol MRI must not be less than 2 weeks.

      4. Pathologic specimens from radical prostatectomy must be provided for whole mount analysis.

      5. Patients will sign a study-specific consent prior to study entry.

      6. Men above the age of 40 years old

      Exclusion Criteria

      1. Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.

      2. Patients unwilling or unable to undergo MRI including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.

      3. Patients who cannot tolerate or have contra-indications to ERC insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease.

      4. Patients with an allergic reaction to latex.

      5. Cryosurgery, surgery for prostate cancer including TURP, prostatic radiotherapy, including bradiotherapy for rectal cancer, androgen deprivation therapy, rectal surgery, or alternative medicine prior to radical prostatectomy.

      6. Any metallic implant (e.g. hip) or device that might distort local magnetic field and compromise quality of MRI.

      7. Radical prostatectomy or biopsy of the prostate not planned to be performed within six (6) months of protocol MRI.

      8. Patients who have undergone BCG for bladder cancer.

      9. Patients with severe motion artifacts rendering the data unusable.

      10. Patients who have an allergic history to gadopentetate dimeglumine administration.

      11. Patients with a contraindication to the administration of glucagon (pheochromocytoma, islet pancreatic tumor, or insulin-dependent diabetes) or a prior history of allergic reaction following glucagon administration.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

      Sponsors and Collaborators

      • Beth Israel Deaconess Medical Center
      • National Institutes of Health (NIH)
      • National Cancer Institute (NCI)

      Investigators

      • Principal Investigator: David C Alsop, PhD, Beth Israel Deaconess Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      David Alsop, Director of MR Research, Beth Israel Deaconess Medical Center
      ClinicalTrials.gov Identifier:
      NCT00831142
      Other Study ID Numbers:
      • 2006P000154
      • 5R01CA116465-04
      First Posted:
      Jan 28, 2009
      Last Update Posted:
      May 20, 2021
      Last Verified:
      May 1, 2021
      Keywords provided by David Alsop, Director of MR Research, Beth Israel Deaconess Medical Center
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of May 20, 2021