Actively Recruiting
Radiologically Guided Biopsies to Study Resistance Mechanisms in Metastatic Castration Resistant Prostate Cancer Patients Receiving 177Lu-PSMA Radioligand Therapy
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with metastatic castration-resistant prostate cancer to understand why some tumors resist treatment with 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy. The study aims to learn how well this therapy kills tumor cells by using image-guided biopsies to analyze changes in tumor, immune, and stromal cells, as well as genetic mutations that may cause resistance. Participants will undergo image-guided biopsies before starting treatment and again 2 to 4 weeks after their second cycle of 177Lu-PSMA-617 therapy. These biopsies will be examined through various laboratory techniques including histopathology, immunohistochemistry, RNA sequencing, and proteomic analyses to assess molecular and cellular changes resulting from the therapy. Throughout the study, researchers will monitor biopsy results to measure treatment impact, focusing on the proportion of patients with successful biopsies showing molecular alterations and gene mutations related to resistance. The primary evaluation occurs at the end of the second treatment cycle, which lasts six weeks. This phase 1 trial is led by the Jonsson Comprehensive Cancer Center and includes careful diagnostic procedures and follow-ups to guide better treatment planning.
CONDITIONS
Brief Title
Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer patient
- Histologically confirmed prostate cancer
- Eligible for 177Lu-PSMA-617 therapy under expanded access or approved trial
- Evidence of lymph node or soft tissue metastatic disease suitable for image-guided biopsy
- Platelet count greater than 75,000/ul within 14 days prior to biopsy
- Prothrombin time (PT) or INR and partial thromboplastin time (PTT) less than 1.5 times the institutional upper limit within 14 days prior to biopsy
- Patients on anticoagulants eligible if they can safely stop medication one week before biopsy with physician agreement
You will not qualify if you...
- Significant congenital or acquired bleeding disorders (e.g., von Willebrand disease, acquired bleeding factor inhibitors)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo an image-guided biopsy at baseline to identify molecular and cellular alterations before treatment.
1 visit (in-person)
Duration - At least 12 weeks (2 cycles)
Participants receive 177Lu-PSMA-617 radioligand therapy in cycles of 6 weeks each.
2 treatment cycles
Duration - 2 to 4 weeks after cycle 2
Participants undergo a second image-guided biopsy 2 to 4 weeks after completing cycle 2 of the radioligand therapy to assess resistance mechanisms.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
A
Ankush Sachdeva
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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