Prostate Cancer Clinical Trial

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

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.

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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.

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT04857502

Recruitment Status:

Recruiting

Sponsor:

Jonsson Comprehensive Cancer Center

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There is 1 Location for this study

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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States More Info
Deepu Varughese
Contact
310-206-7372
[email protected]
Ankush Sachdeva
Contact
310-794-3421
[email protected]
Jeremie Calais, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT04857502

Recruitment Status:

Recruiting

Sponsor:


Jonsson Comprehensive Cancer Center

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