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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
Category
Molecular & Medical Pharmacology
Oncology
Principal Investigator
JEREMIE CALAIS
Contact
JEREMIE CALAIS
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04857502
For detailed technical eligibility, visit ClinicalTrials.gov.