Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

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

• 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)

Locations
United States
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Ankush Sachdeva
asachdeva@mednet.ucla.edu
310-794-3421
Time Frame
Start Date: 2024-04-26
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Diagnostic (image-guided biopsy)
Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov