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

About

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.

Primary Purpose

Basic science

Study Type

Interventional

Phase

Pilot/Feasibility

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

N/A

Maximum Age

N/A

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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Study Stats

Protocol No.

20-002256