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

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Experimental beta probe; Diagnostic Test: PSMA-PET

• Registration Number: NCT03213951
• Lead Sponsor: Indiana University

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-08
• Study First Posted: 2017-07-11
• Study Start: 2017-08-18
• Primary Completion: 2019-11-13
• Study Completion: 2019-11-13
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-25
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cancer	Experimental beta probe	Gleason grade group 1-5 on prostate biopsy or prostate cancer recurrence.
Prostate cancer	PSMA-PET	Gleason grade group 1-5 on prostate biopsy or prostate cancer recurrence.

Primary Outcome Measures

Name	Time	Method
Proportion of patients where prostate cancer was detected using the beta probe on excised prostate tissue	1 day

Secondary Outcome Measures

Name	Time	Method
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	1 day
Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with surgical observations	1 day
Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with clinical tissue histopathology observations	1 day
Comparison of pre-operative 68Ga-PSMA-11 (CT or MRI) lesions measurements with post-operative ex-vivo PET of prostate tissue	1 day

Trial Locations

Locations (2)

Indiana University Health Hospital; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States