NCT06815354 Comprehensive Assessment of Cancer Theranostic Response
| NCT ID | NCT06815354 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AIQ Solutions |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2026-03-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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.
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