Status:
NOT_YET_RECRUITING
Low-Count Quantitative SPECT for Men Treated With Radium-223
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Prostate Cancer
Cancer of the Prostate
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Internal radiotherapies (radiolabeled molecules that are systemically administered and localize to sites of disease) provide cancer-ablating doses to diseased cells while sparing adjacent normal tissu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07221825
Start Date
November 30 2025
End Date
November 30 2027
Last Update
October 30 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110