Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy
Recruiting · NCT05398302 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Image Guided Biopsy
What this trial is about
This clinical trial studies mechanisms of resistance to 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy using image-guided biopsies in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Diagnostic procedures, such as image guided biopsies, may help in learning how well 177Lu-PSMA works to kill tumor cells and allow doctors to plan better treatment.
Who can take part
Age range
No age limits stated
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Volunteer patient
- Histologically confirmed prostate cancer
- Eligible for 177Lu-PSMA-617 under expanded access protocol (IRB# 21-5010) or as part of an approved trial
- Based on positron emission tomography (PET)/computed tomography (CT) images: Evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy
- Platelets \> 75,000/ul within 14 days prior to biopsy
- Prothrombin time (PT) or International normalized ratio (INR) and a partial thromboplastin time (PTT) \< 1.5 times the institutional upper limit normal (ULN) within 14 days prior to biopsy
- Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)
Exclusion criteria
- Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible
Where it is running
1 location listed across 1 US state.
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles, California, United States