Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental beta probe | Other | — | UNRESOLVED |
| PSMA-PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostate cancer
- description
- Gleason grade group 1-5 on prostate biopsy or prostate cancer recurrence.
- interventionNames
- Other: Experimental beta probe
- Diagnostic Test: PSMA-PET
Primary outcomes (1)
- measure
- Proportion of patients where prostate cancer was detected using the beta probe on excised prostate tissue
- timeFrame
- 1 day
Secondary outcomes (4)
- 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
- timeFrame
- 1 day
- measure
- Proportion of patients who had cancer detected by the beta probe on excised prostate tissue compared with surgical observations
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTBahler 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 31430234