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

Metastatic Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05398302
• Other study ID #: 22-000460
• Secondary ID: NCI-2021-12416
• Status: Recruiting
• Phase: Phase 1
• Start date: April 26, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Jonsson Comprehensive Cancer Center
• Contact: Ankush Sachdeva
• Phone: 310-794-3421
• Email: asachdeva[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies mechanisms of resistance to 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy using image-guided biopsies in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Diagnostic procedures, such as image guided biopsies, may help in learning how well 177Lu-PSMA works to kill tumor cells and allow doctors to plan better treatment.

Description:

PRIMARY OBJECTIVE: I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with molecular and cellular alterations in tumor, immune and stromal cells after radioligand therapy assessed by histopathology/immunohistochemistry, ribonucleic acid (RNA)-sequencing and proteomic/phospho-proteomic analyses of biopsy samples. SECONDARY OBJECTIVE: I. Sequencing to identify frequently mutated genes. OUTLINE: Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Image Guided Biopsy
Undergo image-guided biopsy

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Proportion of patients with gene mutations that might confer resistance to RLT		At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)