Prostate CancerTRAQinformNCT06815354
Comprehensive Assessment of Cancer Theranostic Response
A study testing TRAQinform Theranostics in people with Prostate Cancer, run by AIQ Solutions at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TRAQinform Theranostics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M.D. Anderson Cancer Center
Houston, Texas, 77030
Weill Medical College of Cornell
New York, New York, 10065
About this study
Official title: Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform Theranostics
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.
Read the detailed 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.
- Conditions
- Prostate Cancer
- Being tested
- TRAQinform Theranostics
- Keywords
- Prostate Cancer, Theranostics, PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAQinform TheranosticsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Prostate Cancer | Other | 32 patients with metastatic prostate cancer planned to start treatment with 177Lu-PSMA (Pluvicto) will be enrolled. Receives: Device: TRAQinform Theranostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate intent to change treatment decisions after the addition of the TRAQinform Theranostics
Medical teams make a treatment decision using the PSMA PET/CT, diagnostic CT, and other clinical data without the TRAQinform Theranostics analysis report. A treatment decision questionnaire is completed. The medical team is then given the TRAQinform Theranostic report, and the treatment decision questionnaire is completed again.
TRAQinform Theranostic analyzes PSMA PET/CT and CTs. A pdf report allows a medical team to view and interpret the TRAQinform outputs. The report is a theranostic tracer concordance analysis of the PSMA PET/CT and the diagnostic CT for lesions and organs. PSMA PET/CT metrics include SUVmax, SUVmean, Volume and Slice. CT metrics include Volume and Slice. Treatment decisions with/without TRAQinform Theranostics report will be evaluated by calculating the Kappa Index, reported with corresponding 95% confidence interval. Logistic regression analysis will be conducted to correlate decisions with outcomes.
Measured: 12 weeks
Secondary outcomes (1)
Investigate if treatment efficacy and treatment-related toxicity could be detected by the TRAQinform Theranostics
Clinical reports and patient history information from the PRRT patient dataset will be used to identify patients with PRRT-related toxicities (nephrotoxicity, xerostomia, bone pain flair, thrombocytopenia). Toxicity type, grade, and date of first known presence of toxicity will be captured. In addition to identifying single imaging metrics that may predict toxicity, an updated TRAQinform Profile model will be trained to predict patient toxicity status using baseline only imaging and dosimetry metrics and a combination of baseline, follow-up, and response metrics.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start2 Dec 2024
- Primary completion31 Aug 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Recruited patients will receive a PSMA PET/CT at week 12 in addition to SOC baseline PSMA PET/CT and diagnostic CT and week 12 diagnostic CT images. After each follow-up PET/CT, the local team will make a clinical decision about the care of the patient, using the PET/CT images and other relevant clinical data, but without information provided by TRAQinform Theranostics, and answer a investigator questonnaire. The design is modeled after intent-to-change studies con-ducted by the National Oncology PET Registry (NOPR).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIQ Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Weill Medical College of Cornell University, M.D. Anderson Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815354
- Sponsor's protocol ID
- AIQ 24-3216
- Other IDs
- 5R44CA285006-02
- Acronym
- TRAQinform
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform Theranostics
- ClinicalTrials.gov ID
- NCT06815354
- Acronym / sponsor ID
- TRAQinform / AIQ 24-3216
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Theranostics, PET/CT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AIQ SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Weill Medical College of Cornell University, M.D. Anderson Cancer Center
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Recruited patients will receive a PSMA PET/CT at week 12 in addition to SOC baseline PSMA PET/CT and diagnostic CT and week 12 diagnostic CT images. After each follow-up PET/CT, the local team will make a clinical decision about the care of the patient, using the PET/CT images and other relevant clinical data, but without information provided by TRAQinform Theranostics, and answer a investigator questonnaire. The design is modeled after intent-to-change studies con-ducted by the National Oncology PET Registry (NOPR).
| Arm | Type | Receives |
|---|---|---|
| Metastatic Prostate Cancer | Other | Device: TRAQinform Theranostics32 patients with metastatic prostate cancer planned to start treatment with 177Lu-PSMA (Pluvicto) will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAQinform TheranosticsThis 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. | Device | Metastatic Prostate Cancer |
Primary outcome
Investigate intent to change treatment decisions after the addition of the TRAQinform Theranostics
Time frame: 12 weeks
Medical teams make a treatment decision using the PSMA PET/CT, diagnostic CT, and other clinical data without the TRAQinform Theranostics analysis report. A treatment decision questionnaire is completed. The medical team is then given the TRAQinform Theranostic report, and the treatment decision questionnaire is completed again. TRAQinform Theranostic analyzes PSMA PET/CT and CTs. A pdf report allows a medical team to view and interpret the TRAQinform outputs. The report is a theranostic tracer concordance analysis of the PSMA PET/CT and the diagnostic CT for lesions and organs. PSMA PET/CT metrics include SUVmax, SUVmean, Volume and Slice. CT metrics include Volume and Slice. Treatment decisions with/without TRAQinform Theranostics report will be evaluated by calculating the Kappa Index, reported with corresponding 95% confidence interval. Logistic regression analysis will be conducted to correlate decisions with outcomes.
1 secondary outcome
Investigate if treatment efficacy and treatment-related toxicity could be detected by the TRAQinform Theranostics
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAQinform Theranostics in people with Prostate Cancer, run by AIQ Solutions at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate intent to change treatment decisions after the addition of the TRAQinform Theranostics (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.