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

March 25, 2023 updated by: Clinton Bahler, Indiana University

Pilot Ex-Vivo Investigation of an Experimental Beta Probe for Assessment and Guidance of Prostate Cancer Resection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This patient population will have Prostate cancer with planned surgical resection (GG2-5) of prostate cancer as part of routine clinical care or active surveillance/HIFU (GG1-3).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate cancer
Gleason grade group 1-5 on prostate biopsy or prostate cancer recurrence.
Other: Experimental beta probe
3mCi (or similar) dose of 68Ga-PSMA-11 will be given prior to resection of cancer. Experimental beta probe designed to detect 68Ga-PSMA-11 will be used on prostate tissue after it has been surgically removed.
Diagnostic test: PSMA-PET
PSMA-PET imaging done prior to surgery and compared to whole mount imaging.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 day
Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with surgical observations
Time Frame: 1 day
1 day
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
1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

IntraMedical Imaging, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2017

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

July 8, 2017

First Submitted That Met QC Criteria

July 8, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUSCC-0615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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