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99mTc-PSMA-I&S Biodistribution in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04857502
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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
Prostate Carcinoma Recurrent Prostate Carcinoma Drug: 99mTc-based PSMA Imaging and Surgery Agent Procedure: Computed Tomography Procedure: Single Photon Emission Computed Tomography Early Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. 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:

I. 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.

II. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Names:
  • Medical Imaging, Single Photon Emission Computed Tomography
  • Single Photon Emission Tomography
  • single-photon emission computed tomography
  • SPECT
  • SPECT imaging
  • SPECT SCAN
  • SPET
  • tomography, emission computed, single photon
  • Tomography, Emission-Computed, Single-Photon




Primary Outcome Measures :
  1. 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 Frame: time from injection to imaging (range: 1-46 hours) ]

Secondary Outcome Measures :
  1. 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 Frame: time from injection to imaging (range: 1-46 hours) ]
  2. 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 Frame: time from injection to imaging (range: 1-46 hours) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with PCa (primary or recurrent disease)
  • Men who received a 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) for staging or restaging
  • Men with evidence of lymph nodes (LNs)-positive disease on 68Ga-PSMA-11 PET/CT
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857502


Contacts
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Contact: Ankush Sachdeva 310-794-3421 ASachdeva@mednet.ucla.edu
Contact: Kathleen Nguyen 310 206-7372 KathleenNguyen@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Ankush Sachdeva    310-794-3421    ASachdeva@mednet.ucla.edu   
Contact: Kathleen Nguyen    310 206-7372    KathleenNguyen@mednet.ucla.edu   
Principal Investigator: Jeremie Calais, MD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Jeremie Calais, MD UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04857502    
Other Study ID Numbers: 20-002256
NCI-2021-01793 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-002256 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases