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

Conditions

• Prostate Carcinoma
• Recurrent Prostate Carcinoma

Eligibility Criteria

Sex

MALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 99mTc-based PSMA Imaging and Surgery Agent — DRUG
  Given via IV injection
• Computed Tomography — PROCEDURE
  Undergo SPECT/CT
• Single Photon Emission Computed Tomography — PROCEDURE
  Undergo SPECT/CT

Study Details

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.

Key Dates

Start date

Apr 27, 2021

Status verified

Mar 2026

Primary completion

Jun 1, 2026

Completion

Jun 1, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Diagnostic (99mTc-PSMA-I&S, SPECT/CT)
  The first 5 patients receive an initial dose of undergo 99mTc-PSMA-I\&S 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 standard of care surgery.

Primary Outcome Measure

The biodistribution of 99mTc-PSMA-I&S in normal and malignant tissues of patients with prostate cancer will be measured by average and maximum standardized uptake value (SUVmean and SUVmax) [ Time Frame: time from injection to imaging (range: 1-46 hours) ]

Central Contacts

• Deepu Varughese
  310-206-7372
  [email protected]
• Ankush Sachdeva
  310-794-3421
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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