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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center

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