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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    30
  • sponsor
    Jonsson Comprehensive Cancer Center
Updated on 16 June 2021

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.

Details
Condition Malignant neoplasm of prostate, Recurrent Prostate Carcinoma, Recurrent Prostate Cancer, prostate carcinoma
Treatment computed tomography, single photon emission computed tomography, 99mTc-based PSMA Imaging and Surgery Agent
Clinical Study IdentifierNCT04857502
SponsorJonsson Comprehensive Cancer Center
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

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
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