RecruitingPhase 1NCT05398302

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

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


Sponsor

Jonsson Comprehensive Cancer Center

Enrollment

30 participants

Start Date

Apr 26, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALE

Inclusion Criteria7

  • 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 Criteria1

  • Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible

Interventions

PROCEDUREImage Guided Biopsy

Undergo image-guided biopsy


Locations(1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

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NCT05398302


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