RECRUITINGINTERVENTIONAL

Comprehensive Assessment of Cancer Theranostic Response

Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform Theranostics

About This Trial

The intent of this study is to evaluate actionable outputs from TRAQinform Theranostics in a prospective, multi-center, non-interventional clinical study. The primary objective is to investigate intent-to-change treatment decisions after the addition of TRAQinform Theranostics. The exploratory objective is to investigate if treatment efficacy and treatment-related toxicity could be detected by TRAQinform Theranostics following PSMA PET/CT at week 12.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18 years or older and willing and able to provide willing to sign a consent form. - Diagnosis of metastatic prostate cancer. - Planned to start 177Lu-PSMA (Pluvicto). - Ability to tolerate two 68Ga-PSMA or 18F-DCFPyL PET/CT imaging procedures. One at baseline and at 12 weeks of 177Lu-PSMA (Pluvicto) treatment. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at screening. Who Should NOT Join This Trial: - Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age 18 years or older and willing and able to provide informed consent. * Diagnosis of metastatic prostate cancer. * Planned to start 177Lu-PSMA (Pluvicto). * Ability to tolerate two 68Ga-PSMA or 18F-DCFPyL PET/CT imaging procedures. One at baseline and at 12 weeks of 177Lu-PSMA (Pluvicto) treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at screening. Exclusion Criteria: * Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial.

Treatments Being Tested

DEVICE

TRAQinform Theranostics

This prospective, multi-center, non-interventional clinical study will evaluate actionable outputs from TRAQinform Theranostics, a software only medical device that identifies, quantifies, tracks, and compares lesions between different imaging modalities and multiple imaging timepoints.

Locations (2)

Weill Medical College of Cornell

New York, New York, United States

M.D. Anderson Cancer Center

Houston, Texas, United States