Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.

Image Guided Biopsy

Matthew Rettig

This trial studies image-guided biopsies work in identifying mechanisms of resistance in participants with castration resistant prostate cancer that has spread to other places in the body and who are undergoing radioligand therapy (RLT). Tissue sample collected from a biopsy may help determine why response to RLT varies among patients, and this may help researchers to find better treatments for advanced prostate cancer.

PRIMARY OBJECTIVES:

I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with altered signaling pathways after radioligand therapy assessed by phospho-proteomics of biopsy samples.

SECONDARY OBJECTIVES:

I. Generation of patient derived xenograft (PDX) models to determine if tumor levels of activity for individual adaptive pathways are related to the best prostate specific antigen (PSA) response.

II. Sequencing to identify frequently mutated genes such as TP53 and ATM.

OUTLINE:

Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.

Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy

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

No statistical power analysis was performed as this is a pilot study. An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy. The study will in subsequent studies use the information obtained here to design a more definitive trial.

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

The radiologist will perform a routine ultrasonic guided biopsy procedure using the Smart Biopsy Device, with the device readings not visible (i.e. the radiologist will be blinded to device readings)

The radiologist will perform a routine ultrasonic guided biopsy procedure using the smart biopsy system, with the device readings not visible (i.e. the radiologist will be blinded to device readings)

Smart Biopsy Device

Noemi Weisenberg

This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.

This is a single arm, multicenter study. It will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast.

The study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.

In Vivo Smart Biopsy Device Protocol In Radiology

AEs will be documented during the biopsy procedure and SAEs will be followed up to 3 weeks after the biopsy procedure. Rates of adverse events such as bleeding, hematoma, infection and pain will be compared to adverse events for similar procedures published in the literature and anticipated in the product risk analysis.

Correlation between pathology results and device readings

A questionnaire will be completed by the radiologist and applicable radiology lab staff to assess the ease of device assembly and handling properties. Each of the eight questions will use the same four point rating scale. At the end of the study the average and standard deviation will be calculated for each of the questions.

Dune Medical Devices

Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

Ankush Sachdeva

Johannes Czernin, MD

Johannes Czernin

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.

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.

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy	NCT03596710	Castration-Resi... Metastatic Pros... Stage IV Prosta...	Image Guided Bi...	-	Jonsson Comprehensive Cancer Center
In Vivo Smart Biopsy Device Protocol In Radiology	NCT03914911	Breast Cancer Image Guided Bi...	Smart Biopsy De...	18 Years -	Dune Medical Devices
In Vivo Smart Biopsy Device Protocol In Radiology	NCT03914911	Breast Cancer Image Guided Bi...	Smart Biopsy De...	18 Years -	Dune Medical Devices
Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy	NCT05398302	Castration-Resi... Metastatic Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Image Guided Bi...	-	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for image guided biopsy