Low-Count Quantitative SPECT for Men Treated With Radium-223
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Single-photon emission computed tomography (SPECT) imaging offers a mechanism to quantify uptake; however, αRPT administered activities are significantly lower than those used with diagnostic procedures, which presents a challenge for quantitation with conventional methods."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a scan called LC-QSPECT can measure where radium-223 (Xofigo), a radiation drug, goes in the body and how well people tolerate the scan. It is for adult men with prostate cancer that keeps growing despite treatment to lower testosterone and has spread to bones, causing symptoms.
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 tissues. \[223Ra\]RaCl2 (Xofigo) is the first FDA-approved alpha-particle emitting radiopharmaceutical therapy (αRPT), providing a survival benefit for men with bone metastatic castration-resistant prostate cancer. Systemically administered radiotherapies distribute throughout the patient, accumulating to unknown levels at sites of disease and in radiosensitive vital organs. The whole-body distribution means that absorbed doses in the patient extend far beyond a pre-defined treatment field. There is a lack of information about αRPT distribution and localization, and this confounds treatment monitoring, complicates dose and schedule personalization, and impedes drug development. Single-photon emission computed tomography (SPECT) imaging offers a mechanism to quantify uptake; however, αRPT administered activities are significantly lower than those used with diagnostic procedures, which presents a challenge for quantitation with conventional methods. Preliminary research shows that low-count quantitative SPECT (LC-QSPECT) imaging demonstrates reliable quantitation of regional uptake for αRPTs. The purpose of this study is to demonstrate the feasibility, tolerability and performance of LC-QSPECT imaging.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Patients: Have prostate cancer confirmed by a tissue or cell test that keeps growing despite treatment to lower testosterone, with symptoms from cancer in the bones.
- Have at least 3 areas of cancer in the bones that can be detected.
- Be able to receive Xofigo and be at least 18 years old.
- Have an ECOG activity score of 0–3, a rating of how well you can do daily tasks.
- Understand and agree to sign the study consent form. A legally approved representative may give consent for you.
- Doctors: Be a cancer doctor who uses medicines or radiation at Siteman Cancer Center.
- Treat patients with prostate cancer.
- Be willing to complete the doctor questionnaire during the study.
Who can't join
- Most of the cancer spread is in internal organs rather than bones.
- Have another past or current cancer that could affect how the study judges safety or treatment results.
- Have an illness that is not controlled, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat.
- Receive another radioactive drug at the same time.
- Cannot lie still on your back for 45–60 minutes.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Abhinav K Jha, Ph.D. · Study contact · 314-273-2655 · a.jha@wustl.eduAbhinav K Jha, Ph.D. · Principal investigatorDaniel Thorek, Ph.D. · Sub-investigatorTyler J Fraum, M.D. · Sub-investigatorMore trials in St Louis