Mechanisms of Resistance to PSMA Radioligand Therapy
Recruiting · NCT05435495 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
Blood DrawSingle-photon emission computed tomographyTumor Biopsy
What this trial is about
This is a multicenter, correlative study to existing Lutetium based prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) trials and uses.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
3 locations listed across 2 US states.
- University of California, Los Angeles - Los Angeles, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Memorial Sloan Kettering - New York, New York, United States