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

RecruitingEARLY Phase 1Ages any - anyMaleJonsson Comprehensive Cancer Center
NCT04857502 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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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What it tests

  • 99mTc-based PSMA Imaging and Surgery Agent
  • Computed Tomography
  • Single Photon Emission Computed Tomography
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Where

1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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