Clinical Trials /

Ex-vivo Investigation of Beta Probe for Prostate Cancer Resection and Evaluation of PSMA-PET for Diagnosis of Intraprostatic Lesions

NCT03213951

Description:

68Ga-PSMA is a radiopharmaceutical used with PET imaging for the detection of prostate cancer under a compassionate IND in patients who have presented with biochemical failure. In this study, the use of 68Ga-PSMA-11 will be extended to newly diagnosed patients with high risk prostate cancer. Patients enrolled to this study will undergo a 68Ga-PSMA-11 PET/CT or PET/MRI scan for research purposes (in addition to the routine CT or MRI that is routinely done for staging), and a second 68Ga-PSMA-11 administration just prior to surgery for experimental ex-vivo beta probe testing of resected tissue. Immediately following resection of the prostate, the intact tissue will be scanned using a PET camera designed for animal research in order to record the 68Ga-PSMA-11 distribution in the isolated tissue at higher resolution than can be attained using whole-body PET imaging. The experimental beta probe will then be use to measure 68Ga-PSMA-11 counts of the resected tissue.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Completed

URL:

https://clinicaltrials.gov/show/NCT03213951

Trial Eligibility

Document

Title

  • Brief Title: Ex-vivo Investigation of Beta Probe for Prostate Cancer Resection and Evaluation of PSMA-PET for Diagnosis of Intraprostatic Lesions
  • Official Title: Pilot Ex-Vivo Investigation of an Experimental Beta Probe for Assessment and Guidance of Prostate Cancer Resection

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0615
  • NCT ID: NCT03213951

Conditions

  • Prostate Cancer

Purpose

68Ga-PSMA is a radiopharmaceutical used with PET imaging for the detection of prostate cancer under a compassionate IND in patients who have presented with biochemical failure. In this study, the use of 68Ga-PSMA-11 will be extended to newly diagnosed patients with high risk prostate cancer. Patients enrolled to this study will undergo a 68Ga-PSMA-11 PET/CT or PET/MRI scan for research purposes (in addition to the routine CT or MRI that is routinely done for staging), and a second 68Ga-PSMA-11 administration just prior to surgery for experimental ex-vivo beta probe testing of resected tissue. Immediately following resection of the prostate, the intact tissue will be scanned using a PET camera designed for animal research in order to record the 68Ga-PSMA-11 distribution in the isolated tissue at higher resolution than can be attained using whole-body PET imaging. The experimental beta probe will then be use to measure 68Ga-PSMA-11 counts of the resected tissue.

Detailed Description

      Primary Objective To assess beta ray detection of prostate cancer ex-vivo using experimental
      beta probe immediately after prostate cancer removal as determined by pathologist.

      Secondary Objectives

        -  Compare preoperative standard of care staging via CT or MRI to 68Ga-PSMA-11 PET (CT or
           MRI) findings.

        -  Compare preoperative 68Ga-PSMA-11 PET (CT or MRI) lesion measurements with postoperative
           high-resolution PET of ex-vivo tissue.

        -  To compare the findings of each of the 68Ga-PSMA-11 detection methods to the surgical
           observations and the clinical tissue histopathology findings.

      Exploratory Objective Correlation of beta probe measurements with preoperative 68Ga-PSMA-11
      PET (CT or MRI) lesion measurements, postoperative PET/CT ex-vivo images, surgical
      observations, and pathology findings.

Trial Arms

NameTypeDescriptionInterventions
Prostate cancerGleason grade group 1-5 on prostate biopsy or prostate cancer recurrence.

    Eligibility Criteria

            Inclusion Criteria

        To be considered eligible to participate in this study, a patient must meet all the
        inclusion criteria listed below:

          1. ≥ 18 years of age

          2. Must provide written informed consent

          3. Presence of high grade prostate cancer (Gleason grade group 1-5) on prostate biopsy or
             prostate cancer recurrence.

          4. Scheduled for prostate cancer removal

          5. Willing and able to lie still for approximately 30 minutes in an enclosed space for
             the 68Ga-PSMA-11 PET CT or MRI

        Exclusion Criteria

          1. Participation in another investigational trial involving research exposure to ionizing
             radiation concurrently or within 30 days.

          2. Significant acute or chronic medical, neurologic, or psychiatric illness in the
             subject that, in the judgment of the Principal Investigator, could compromise subject
             safety, limit the subject's ability to complete the study, and/or compromise the
             objectives of the study.
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Proportion of patients where prostate cancer was detected using the beta probe on excised prostate tissue
    Time Frame:1 day
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Proportion of patients who had cancer detected by both the standard of care imaging (CT or MRI) and the 68Ga-PSMA-11 PET (CT or MRI) imaging
    Time Frame:1 day
    Safety Issue:
    Description:
    Measure:Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with surgical observations
    Time Frame:1 day
    Safety Issue:
    Description:
    Measure:Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with clinical tissue histopathology observations
    Time Frame:1 day
    Safety Issue:
    Description:
    Measure:Comparison of pre-operative 68Ga-PSMA-11 (CT or MRI) lesions measurements with post-operative ex-vivo PET of prostate tissue
    Time Frame:1 day
    Safety Issue:
    Description:

    Details

    Phase:
    Primary Purpose:Observational
    Overall Status:Completed
    Lead Sponsor:Indiana University

    Trial Keywords

    • Surgical resection
    • Margins of resection
    • Beta radiopharmaceutical
    • Beta probe device
    • Ex-vivo

    Last Updated

    April 7, 2020