Summary

Eligibility
for males (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jeremie Calais, MD (ucla)

Description

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.

Official Title

99mTc-PSMA-I&Amp;S in Patients With Prostate Cancer: An Exploratory Biodistribution Study With Histopathology Validation

Details

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.

Keywords

Prostate Carcinoma Recurrent Prostate Carcinoma Carcinoma Prostatic Neoplasms 99mTc-based PSMA Imaging and Surgery Agent Computed Tomography Single Photon Emission Computed Tomography

Eligibility

You can join if…

Open to males

  • 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

You CAN'T join if...

  • Patients who started any PCa treatment between study enrollment and surgery
  • Technically inaccessible nodal location

Location

  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

  • Jeremie Calais, MD (ucla)
    HS Assistant Clinical Professor, Molecular and Medical Pharmacology. Authored (or co-authored) 65 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT04857502
Phase
Phase 1
Study Type
Interventional
Last Updated