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

Jonsson Comprehensive Cancer Center

Status and phase: Enrolling; Early Phase 1

Conditions: Prostate Carcinoma; Recurrent Prostate Carcinoma

Treatments: Drug: 99mTc-based PSMA Imaging and Surgery Agent; Procedure: Single Photon Emission Computed Tomography; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT04857502

20-002256 (Other Identifier)

NCI-2021-01793 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Diagnostic (99mTc-PSMA-I&S, SPECT/CT)

Experimental group

Description:

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.

Treatment:

Procedure: Computed Tomography

Procedure: Single Photon Emission Computed Tomography

Drug: 99mTc-based PSMA Imaging and Surgery Agent