Evaluating the impact of TRAQinform Theranostics on prostate cancer treatment decisions
Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform Theranostics
This study is testing if a new software tool can help doctors make better treatment choices for men with advanced prostate cancer who are starting a specific therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | AIQ Solutions Industry-sponsored |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06815354 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical impact of TRAQinform Theranostics, a software device that analyzes imaging data to inform treatment decisions for metastatic prostate cancer patients. The study will enroll 32 patients who are about to start treatment with 177Lu-PSMA (Pluvicto) and will undergo PET/CT imaging at baseline and again at week 12. The primary goal is to determine if the addition of TRAQinform Theranostics influences treatment decisions, while the exploratory goal is to evaluate treatment efficacy and toxicity at the 12-week mark. The study will utilize multi-center data and involve collaboration with prominent cancer institutions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of metastatic prostate cancer who are about to start 177Lu-PSMA treatment.
Not a fit: Patients with concurrent diseases or conditions that may interfere with participation in the trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment decision-making for prostate cancer patients, potentially leading to improved outcomes.
How similar studies have performed: While the use of theranostics in cancer treatment is an emerging field, similar studies have shown promise in improving treatment outcomes, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 1 other locations
- Weill Medical College of Cornell — New York, New York, United States (Recruiting)
- M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Dona Alberti, RN, MSN
- Email: dona.alberti@aiq-solutions.com
- Phone: 608-268-9684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.