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Image-Guided Biopsies for 177Lu-PSMA Resistance in Metastatic Prostate Cancer

This study is for men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to hormone therapy). It aims to understand why some patients might not respond to a treatment called 177Lu-PSMA radioligand therapy. You would undergo image-guided biopsies (a procedure to take small tissue samples using imaging to guide the needle) to look for changes in your tumor cells after receiving 177Lu-PSMA. The goal is to identify these changes, called molecular and cellular alterations, to help doctors plan better treatments in the future. The study plans to enroll 30 participants.

Study design
This is an interventional study, meaning you will receive a specific procedure. It plans to enroll 30 men.
What's involved
You would undergo an image-guided biopsy at the start of the study and again 2-4 weeks after your second cycle of 177Lu-PSMA-617 therapy.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at the end of cycle 2 before the start of cycle 3 of radioligand therapy (each cycle is six weeks).

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NCT05398302

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

Recruiting
PHASE1All AgesInterventionalDiagnostic
Jonsson Comprehensive Cancer Center
~30 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Image Guided Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT)
Measured over At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)

Conditions

Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8

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Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Johannes Czernin · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Ankush Sachdeva
[email protected]
310-794-3421
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT)At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)