Ex-vivo Investigation of Beta Probe for Prostate Cancer Resection and Evaluation of PSMA-PET for Diagnosis of Intraprostatic Lesions
Pilot Ex-Vivo Investigation of an Experimental Beta Probe for Assessment and Guidance of Prostate Cancer Resection
1 other identifier
observational
28
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
August 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2019
CompletedMarch 28, 2023
March 1, 2023
2.2 years
July 8, 2017
March 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients where prostate cancer was detected using the beta probe on excised prostate tissue
1 day
Secondary Outcomes (4)
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
Study Arms (1)
Prostate cancer
Gleason grade group 1-5 on prostate biopsy or prostate cancer recurrence.
Interventions
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.
PSMA-PET imaging done prior to surgery and compared to whole mount imaging.
Eligibility Criteria
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).
You may qualify if:
- ≥ 18 years of age
- Must provide written informed consent
- Presence of high grade prostate cancer (Gleason grade group 1-5) on prostate biopsy or prostate cancer recurrence.
- Scheduled for prostate cancer removal
- Willing and able to lie still for approximately 30 minutes in an enclosed space for the 68Ga-PSMA-11 PET CT or MRI
You may not qualify if:
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- IntraMedical Imaging, LLCcollaborator
Study Sites (2)
Indiana University Health Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Bahler CD, Green M, Hutchins GD, Cheng L, Magers MJ, Fletcher J, Koch MO. Prostate Specific Membrane Antigen Targeted Positron Emission Tomography of Primary Prostate Cancer: Assessing Accuracy with Whole Mount Pathology. J Urol. 2020 Jan;203(1):92-99. doi: 10.1097/JU.0000000000000501. Epub 2019 Aug 20.
PMID: 31430234RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clinton D. Bahler, MD, MS
Indiana Unversity
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
July 8, 2017
First Posted
July 11, 2017
Study Start
August 18, 2017
Primary Completion
November 13, 2019
Study Completion
November 13, 2019
Last Updated
March 28, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share