Status:
RECRUITING
Mechanisms of Resistance to PSMA Radioligand Therapy
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Prostate Cancer Foundation
Conditions:
Prostate Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, correlative study to existing Lutetium based prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) trials and uses.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the relationship between whole body tumor absorbed dose and response Lutetium based prostate-specific membrane antigen-targeted radioligand therapy (177Lu-PSMA-RLT...
Eligibility Criteria
Inclusion
- Initiating treatment with Lutetium based PSMA-targeted RLT.
- Participants must have a PSMA-avid lesion that is accessible to biopsy. Biopsy of newly emerging radiographic metastases is desired and preferable to the biopsy of previously existing lesions whenever possible. Newly emerging lesions are defined as those that are absent on a previous scan, or those demonstrating unequivocal progression since initiation of the last treatment. Biopsies will be performed according to local institutional standards.
- Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for at least five days prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is approval by the interventional radiologist or the PI.
- Age \>=18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients with significant congenital or acquired bleeding disorders (eg von Wildebrand's disease, acquired bleeding factor inhibitors).
- Patients who are not able to undergo additional study related imaging procedures.
Key Trial Info
Start Date :
October 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT05435495
Start Date
October 21 2021
End Date
December 31 2025
Last Update
January 30 2025
Active Locations (3)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Memorial Sloan Kettering
New York, New York, United States, 10065