Clinical trial Recruiting at 1 site Phase 1 Interventional Men only

Using image-guided biopsies to understand resistance in advanced prostate cancer treatment

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

Run by Jonsson Comprehensive Cancer Center · NCT05398302 · Data updated 2026-11-12

This study is testing how advanced imaging can help doctors understand why some men with hard-to-treat prostate cancer don't respond to a specific therapy, so they can find better treatment options.

Quick facts

PhasePhase 1
Study typeInterventional
SexMen only
Enrollment30 (estimated)
SponsorJonsson Comprehensive Cancer Center
Academic / other
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedApril 26, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedJune 15, 2026
Trial IDNCT05398302 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with histologically confirmed metastatic castration-resistant prostate cancer who are eligible for 177Lu-PSMA-617 therapy.

Probably not a fit

Patients with non-metastatic prostate cancer or those not eligible for 177Lu-PSMA-617 therapy may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the mechanisms of resistance to 177Lu-PSMA radioligand therapy in patients with metastatic castration-resistant prostate cancer. It employs image-guided biopsies to collect tumor samples before and after treatment, allowing for detailed analysis of molecular and cellular changes. The study aims to assess alterations in tumor, immune, and stromal cells through various advanced techniques, including histopathology and RNA sequencing. By understanding these mechanisms, the trial seeks to improve treatment strategies for affected patients.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment plans for patients with advanced prostate cancer by identifying resistance mechanisms.

How similar studies have gone: Other studies have shown promise in using image-guided biopsies to assess treatment responses, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.