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

To fully understand the clinical impact of TRAQinform Theranostics on a clinical workflow, 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. The primary objective of this clinical study 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 can be detected by TRAQinform Theranostics in week 12 of 177Lu-PSMA (Pluvicto) treatment.

This clinical study will enroll 32 metastatic prostate cancer patients, planned to start treatment with 177Lu-PSMA (Pluvicto). Enrolled subjects will receive a 68Ga-PSMA or 18F-DCFPyL PET/CT and a diagnostic CT at baseline (SOC) and again at week 12 of the 177Lu-PSMA treatment. Week 12 PET/CT is for research purposes only and the 68PSMA or 18F-DCFPyL imaging agent may be considered investigational.

Following each imaging timepoint, scans will be transmitted to AIQ for analysis. At baseline and again at week 12, the investigator team, using the PET/CT and other relevant clinical data, will make a treatment decision without TRAQinform Theranostics and complete a questionnaire .

The TRAQinform Theranostics report will then be sent to the investigator team after the patient's treatment decision is made and the team again, will then provide answers to the questionnaire assessing how TRAQinform Theranostics would have impacted treatment decisions.