Low-count SPECT imaging to guide Radium-223 treatment for men with bone-metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers are investigating how well low-count quantitative SPECT imaging can measure Radium-223 distribution in men with castration-resistant prostate cancer and bone metastases. The goal is to improve monitoring and personalize dosing by quantifying radiopharmaceutical uptake throughout the body. The study uses an imaging-based approach alongside standard treatment with Xofigo to see if imaging data correlate with therapeutic effect and safety. Participation is limited to adults with symptomatic bone metastases who are eligible for Radium-223 and can provide informed consent. The study is led by Washington University School of Medicine with collaboration from NIBIB and is conducted at a single site in St. Louis.

Why it matters

Who can join: the full rules

Inclusion Criteria - Patients:

* Histologically or cytologically confirmed castration-resistant prostate cancer with symptomatic bone metastases.
* Minimum detectable skeletal lesion count of 3.
* Eligible to receive Xofigo.
* At least 18 years of age.
* ECOG performance status ≤ 3.
* Ability to understand and willingness to sign an IRB-approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

Exclusion Criteria - Patients:

* Predominant visceral metastatic disease.
* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Concurrent alternative radiopharmaceuticals
* Inability to maintain stationary supine pose for 45-60 minutes

Eligibility Criteria - Physicians:

* Medical Oncologist or Radiation Oncologist at Siteman Cancer Center.
* Treating patients with prostate cancer.
* Willing to complete Physician Questionnaire during participation.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Abhinav K Jha, Ph.D. — Washington University School of Medicine
• Study coordinator: Abhinav K Jha, Ph.D.
• Email: a.jha@wustl.edu
• Phone: 314-273-2655

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.