Image-Guided Biopsies to Identify Mechanisms of Resistanc... | NCT05398302

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

NCT05398302

Sponsor

Jonsson Comprehensive Cancer Center

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

30Estimated

Phase

Phase 1

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

Interventions

Image Guided Biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2021-12416	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 26, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

May 23, 2022

First Submission Date that Met QC Criteria

May 26, 2022

First Posted Date

May 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic (image-guided biopsy)	Experimental	Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.	Procedure: Image Guided Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Image Guided Biopsy	Procedure	Undergo image-guided biopsy	Diagnostic (image-guided biopsy)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ankush Sachdeva	Contact	310-794-3421		asachdeva@mednet.ucla.edu

Overall Officials

Name	Affiliation	Role
Johannes Czernin	UCLA / Jonsson Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA / Jonsson Comprehensive Cancer Center	Recruiting	Los Angeles	California	90095	United States

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013048	Specimen Handling
D003949	Diagnostic Techniques, Surgical
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques