Using image-guided biopsies to understand resistance in advanced prostate cancer treatment
Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05398302 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed metastatic castration-resistant prostate cancer who are eligible for 177Lu-PSMA-617 therapy.
Not a fit: Patients with non-metastatic prostate cancer or those not eligible for 177Lu-PSMA-617 therapy may not benefit from this study.
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 performed: Other studies have shown promise in using image-guided biopsies to assess treatment responses, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Johannes Czernin — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Ankush Sachdeva
- Email: asachdeva@mednet.ucla.edu
- Phone: 310-794-3421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.