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

ConditionsCastration-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

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexMale

AgeNot listed

SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible

Trial design

Design model

Single group

Treatments tested in this trial

Image Guided Biopsy
Procedure/Surgery
Undergo image-guided biopsy

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Diagnostic (image-guided biopsy)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT)

Time frame

At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)

Secondary outcomes

Proportion of patients with gene mutations that might confer resistance to RLT

Time frame

At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)

Sponsors and contacts

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Jonsson Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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