99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer
Study Details
Study Description
Brief Summary
This exploratory study conducted under the RDRC program studies the biodistribution of 99mTc-PSMA-I&S in patients with prostate cancer who undergo pelvic lymph node dissection. Prostate specific membrane antigen (PSMA)-targeted radio-guided surgery uses the preoperative intravenous administration of a PSMA-ligand called PSMA-imaging and surgery (I&S) labeled with the gamma-emitter radioisotope Technetium-99m (99mTc). Giving 99mTc-PSMA-I&S may detect PSMA-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
PRIMARY OBJECTIVE:
- To define the biodistribution of 99mTc-based PSMA imaging and surgery agent (99mTc-PSMA-I&S) in normal and malignant tissues of patients with prostate cancer (PCa) with histopathology validation, when available.
SECONDARY OBJECTIVES:
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To correlate the 99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (SPECT), ex-vivo gamma measurements and level of prostate-specific membrane antigen (PSMA) expression quantified by histopathology, when available.
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To define the best time-point for radio-guided surgery (RGS) with the highest tumor-to-background ratio following 99mTc-PSMA-I&S administration.
OUTLINE:
The first 5 patients receive an initial dose of 99mTc-PSMA-I&S intravenously (IV) followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I&S IV before surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diagnostic (99mTc-PSMA-I&S, SPECT/CT) The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I&S IV followed by 5 SPECT/CT scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. These 5 patients then receive a second dose of 99mTc-PSMA-I&S IV and then undergo standard of care surgery. All subsequent patients receive one dose of 99mTc-PSMA-I&S IV before standard of care surgery. |
Drug: 99mTc-based PSMA Imaging and Surgery Agent
Given via IV injection
Procedure: Computed Tomography
Undergo SPECT/CT
Other Names:
Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax) [time from injection to imaging (range: 1-46 hours)]
Secondary Outcome Measures
- 99mTc-PSMA-I&S accumulation within tumor lesions observed by in-vivo SPECT (SUVmean and SUVmax) will be correlated with ex-vivo gamma measurements (counts/minute) and level of PSMA expression quantified by histopathology (IHC score) [time from injection to imaging (range: 1-46 hours)]
- The best time-point for 99mTc-PSMA-I&S radioguided surgery will be determined by the tumor-to-background uptake ratio (TBR) using the time-activity curve function [time from injection to imaging (range: 1-46 hours)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men with PCa (primary or recurrent disease)
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Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
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Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
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Men who are scheduled for pelvic LN dissection (PLND)
-
Men who can provide oral and written informed consent
-
Men who can comply with study procedures
Exclusion Criteria:
-
Patients who started any PCa treatment between study enrollment and surgery
-
Technically inaccessible nodal location
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- Jonsson Comprehensive Cancer Center
Investigators
- Principal Investigator: Jeremie Calais, MD, UCLA / Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-002256
- NCI-2021-01793
- 20-002256