Low-Count Quantitative SPECT for Men Treated With Radium-223

This study is looking at a new way to measure how much of the cancer medicine Xofigo (Radium-223) goes to bone tumors and other areas in the body. Xofigo is an approved treatment for men with prostate cancer that has spread to the bones and is no longer responding to hormone therapy (castration-resistant prostate cancer). Researchers will use a special imaging scan called LC-QSPECT (low-count quantitative single-photon emission computed tomography) to see how Xofigo is distributed. The main goal is to see if these scans accurately show how much Xofigo is in the tumors and intestine by comparing it to samples taken later. This study is for men aged 18 or older with prostate cancer that has spread to the bones and who are eligible to receive Xofigo. The study plans to enroll 38 participants, but its current status is unclear.

Study design: This is an interventional study, meaning participants will receive a specific intervention (LC-QSPECT scans). It is planned to include 38 participants.
What's involved: You would have LC-QSPECT scans performed between 6 and 36 hours after receiving Xofigo during Cycles 1 and 3. Ex vivo samples will be collected, estimated to be 3 months after the start of the study.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint involves measurements taken through ex vivo sample collection, estimated to be 3 months after the start of the study.

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Low-Count Quantitative SPECT for Men Treated With Radium-223

Recruiting

NAAges 18+InterventionalDiagnostic

Washington University School of Medicine

~38 participants

Updated 2026-07-21 on ClinicalTrials.gov

What's tested:Low-count quantitative single-photon emission computed tomography imaging

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Spearman's correlation coefficient between the LC-QSPECT estimated uptake in the lesions and intestine with ex vivo activity sampling

Measured over Through collection of ex vivo sample (estimated to be 3 months)

Conditions

Prostate Cancer

Cancer of the Prostate

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Abhinav K Jha, Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Abhinav K Jha, Ph.D.

[email protected]

314-273-2655

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

Medical Oncologist or Radiation Oncologist at Siteman Cancer Center.

Treating patients with prostate cancer.

Willing to complete Physician Questionnaire during participation.

What this trial measures

Spearman's correlation coefficient between the LC-QSPECT estimated uptake in the lesions and intestine with ex vivo activity samplingThrough collection of ex vivo sample (estimated to be 3 months)
The investigators will assess if the correlation (in absolute magnitude) ≥ 0.60 between the tissue and SPECT data against a low correlation of \< 0.2 based on 1-sided normal test at a 5% level.

Trialytics