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

Who is this study for? Male patients with Prostate Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Deepu Varughese
DVarughese@mednet.ucla.edu
310-206-7372
Backup
Ankush Sachdeva
ASachdeva@mednet.ucla.edu
310-794-3421
Time Frame
Start Date: 2021-04-27
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov