Overview
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.
Description
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.
To address the status quo bias of each local investigator team, a blinded clinical evaluation of the week 12 questionnaire and any other anonymized clinical data necessary to make a treatment decision (prior taxane treatments, relevant labs, physical examination, treatment toxicities, and recent medical history) will be shared with each site. The investigator teams at each site will independently answer the week 12 questionnaire considering all information but without knowledge of the treatment decision made by the investigator teams at the other site.
It is important to note that the objective of this clinical study is to evaluate only the "intent" to change treatment. The investigator teams agree that patient treatment management decisions will not be affected by the additional information from TRAQinform Theranostics, and no clinical intervention will be implemented.
Eligibility
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.