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

Prostate Carcinoma Clinical Trial

Official title:

99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857502
• Other study ID #: 20-002256
• Secondary ID: NCI-2021-01793
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 27, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: Deepu Varughese
• Phone: 310-206-7372
• Email: DVarughese[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Prostate Carcinoma
• Prostatic Neoplasms
• Recurrent Prostate Carcinoma

Intervention

Drug:
• 99mTc-based PSMA Imaging and Surgery Agent
Given via IV injection

Procedure:
• Computed Tomography
Undergo SPECT/CT
• Single Photon Emission Computed Tomography
Undergo SPECT/CT

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)