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

Launched by JONSSON COMPREHENSIVE CANCER CENTER · May 26, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how some patients with metastatic castration-resistant prostate cancer respond to a specific treatment called 177Lu-PSMA radioligand therapy. The researchers want to understand why some tumors don't respond well to this treatment. To do this, they will perform image-guided biopsies, which are procedures that help doctors take a small sample of tissue from the tumor using imaging technology. This will help them learn more about the tumors and tailor treatments better for patients.

To participate in this trial, patients must have a confirmed diagnosis of prostate cancer that has spread and must be eligible for the 177Lu-PSMA therapy. They need to be male, and their medical condition must meet certain requirements, such as having enough platelets in their blood and being able to safely stop certain blood-thinning medications before the biopsy. If eligible, participants can expect to undergo some imaging tests and biopsies, which will help gain valuable insights into their cancer treatment and potentially improve future therapies.

Gender

MALE

Eligibility criteria

• 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