Prostate CancerNCT07221825
Low-Count Quantitative SPECT for Men Treated With Radium-223
A study testing Low-count quantitative single-photon emission computed tomography imaging in people with Prostate Cancer and Cancer of the Prostate, run by Washington University School of Medicine at 1 site in United States.
Trial 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 tissues. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Cancer of the Prostate
- What is being tested?
- Low-count quantitative single-photon emission computed tomography imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Jul 2028
- 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
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- Medical Oncologist or Radiation Oncologist at Siteman Cancer Center.
- Treating patients with prostate cancer.
- Willing to complete Physician Questionnaire during participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Abhinav K Jha, Ph.D., 314-273-2655, a.jha@wustl.edu
Abhinav K Jha, Ph.D.
About this study
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.
- Conditions
- Prostate Cancer, Cancer of the Prostate
- Being tested
- Low-count quantitative single-photon emission computed tomography imaging
- Keywords
- Prostate cancer, Bone metastasis, SPECT, Radiopharmaceutical therapies, Theranostics, Alpha-particle, Xofigo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-count quantitative single-photon emission computed tomography imagingDevice
Also called LC-QSPECT
LC-QSPECT scans will be performed between 6 and 36 hours after administration of Xofigo during Cycles 1 and 3.
| Study group | Role | What they receive |
|---|---|---|
| LC-QSPECT | Experimental | Consenting and eligible men receiving standard of care (Xofigo) will receive a noninvasive LC-QSPECT scan (~45 minutes) and a low-dose contrast-enhanced CT after Cycles 1 and 3 of Xofigo. SOC CT and bone scans will also be performed at baseline and after Cycles 3 and 6. Specimen collection will be as follows: bone biopsy (Cycle 1 Day 2) (optional), stool (first bowel movement post-each SPECT scan), and blood for PSA and bone turnover biomarkers (with each cycle of treatment). Additionally, pain will be assessed, and quality of life will be monitored prior to treatment and after each treatment cycle. Receives: Device: Low-count quantitative single-photon emission computed tomography imaging |
| Physicians | No intervention | Additionally, medical oncologists and radiation oncologists who are seeing patients who are enrolled in this study will be considered participants in this study (as they will be completing the Physician Questionnaire). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spearman's correlation coefficient between the LC-QSPECT estimated uptake in the lesions and intestine with ex vivo activity sampling
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.
Measured: Through collection of ex vivo sample (estimated to be 3 months)
Secondary outcomes (12)
LC-QSPECT related adverse events
Measured: From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging
Percentage of enrolled patients who withdraw from the study due to adverse events at least possibly related to LC-QSPECT (as chosen by patients or treating physician team)
Measured: From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging
Feasibility of conducting LC-QSPECT will be determined by percentage of SPECT scans that can be processed using the investigators' computational method
Feasibility is defined as at least 80% of scans able to be processed.
Measured: Through completion of LC-QSPECT imaging (estimated to be 3 months)
Correlation between the LC-QSPECT measurements and PSA (Spearman Correlation Coefficient)
Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and PSA doubling time (Spearman Correlation Coefficient)
Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and bone-turnover markers (Spearman Correlation Coefficient)
Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (Spearman Correlation Coefficient)
- Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
- The FACT-P scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and EuroQol-5 (EQ-5D-5L) questionnaire (Spearman Correlation Coefficient)
- Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
- EQ-5D-5L is a descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. Scale Minimum: 0. Scale Maximum: 100. Higher score indicates better outcome.
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and Brief Pain Inventory (BPI) questionnaire (Spearman Correlation Coefficient)
- Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
- BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and bone turnover (Spearman Correlation Coefficient)
Spearman correlation coefficient measures the strength and direction of the linear correlation (dependence) between 2 variables after converting the raw data to ranks, giving a value between +1 and -1 inclusive, where 1 indicates perfect positive correlation, 0 indicates no correlation, and -1 indicates perfect negative correlation.
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Percentage of times that the use of the LC-QSPECT procedure resulted in any changes in treatment plans of the patients
Measured: Through completion of Xofigo treatment (estimated to be 6 months)
Performance of the LC-QSPECT procedure using a no-gold-standard evaluation technique.
- The investigators will use the no-gold-standard technique to assess whether the LC-QSPECT technique yields precise performance on the task of isotope uptake quantification, where slope and noise will be estimated and the noise-to-slope ratio (NSR) will be calculated.
- The no-gold-standard technique can be found here: Jha AK, Caffo B, Frey EC. A no-gold-standard technique for objective assessment of quantitative nuclear-medicine imaging methods. Phys Med Biol. 2016 Apr 7;61(7):2780-800. doi: 10.1088/0031-9155/61/7/2780. Epub 2016 Mar 16. PMID: 26982626; PMCID: PMC4921224 and here: Yan Liu, Ziping Liu, Zekun Li, Daniel Thorek, Barry Siegel, Abhinav Jha, "No-gold-standard evaluation of quantitative SPECT methods for alpha-particle radiopharmaceutical therapy", Journal of Nuclear Medicine Jun 2023, 64 (supplement 1) P1331
Measured: Through completion of LC-QSPECT imaging (estimated to be 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (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.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Abhinav K Jha, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221825
- Sponsor's protocol ID
- 202506234
- Other IDs
- R01EB031962
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified SPECT imaging data, quantitative imaging metrics, and limited clinical variables (e.g., demographics, treatment cycle, administered activity, relevant lab values, clinical outcome measures) may be shared with qualified researchers at academic, nonprofit, or industry institutions for secondary analyses of image data, dosimetry, quantitative modeling, or clinical outcomes related to Radium-223 therapy.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Count Quantitative SPECT for Men Treated With Radium-223
- ClinicalTrials.gov ID
- NCT07221825
- Acronym / sponsor ID
- 202506234
- Conditions
- Prostate Cancer, Cancer of the Prostate
- Keywords
- Prostate cancer, Bone metastasis, SPECT, Radiopharmaceutical therapies, Theranostics, Alpha-particle, Xofigo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 28 Oct 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC-QSPECT | Experimental | Device: Low-count quantitative single-photon emission computed tomography imagingConsenting and eligible men receiving standard of care (Xofigo) will receive a noninvasive LC-QSPECT scan (~45 minutes) and a low-dose contrast-enhanced CT after Cycles 1 and 3 of Xofigo. SOC CT and bone scans will also be performed at baseline and after Cycles 3 and 6. Specimen collection will be as follows: bone biopsy (Cycle 1 Day 2) (optional), stool (first bowel movement post-each SPECT scan), and blood for PSA and bone turnover biomarkers (with each cycle of treatment). Additionally, pain will be assessed, and quality of life will be monitored prior to treatment and after each treatment cycle. |
| Physicians | No intervention | –Additionally, medical oncologists and radiation oncologists who are seeing patients who are enrolled in this study will be considered participants in this study (as they will be completing the Physician Questionnaire). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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 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 |
|---|---|---|
| Low-count quantitative single-photon emission computed tomography imagingAlso: LC-QSPECTLC-QSPECT scans will be performed between 6 and 36 hours after administration of Xofigo during Cycles 1 and 3. | Device | LC-QSPECT |
Primary outcome
Spearman's correlation coefficient between the LC-QSPECT estimated uptake in the lesions and intestine with ex vivo activity sampling
Time frame: Through 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.
12 secondary outcomes
LC-QSPECT related adverse events
Time frame: From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging
Percentage of enrolled patients who withdraw from the study due to adverse events at least possibly related to LC-QSPECT (as chosen by patients or treating physician team)
Time frame: From start of LC-QSPECT imaging through 12 hours following LC-QSPECT imaging
Feasibility of conducting LC-QSPECT will be determined by percentage of SPECT scans that can be processed using the investigators' computational method
Time frame: Through completion of LC-QSPECT imaging (estimated to be 3 months)
Correlation between the LC-QSPECT measurements and PSA (Spearman Correlation Coefficient)
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and PSA doubling time (Spearman Correlation Coefficient)
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and bone-turnover markers (Spearman Correlation Coefficient)
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (Spearman Correlation Coefficient)
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and EuroQol-5 (EQ-5D-5L) questionnaire (Spearman Correlation Coefficient)
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and Brief Pain Inventory (BPI) questionnaire (Spearman Correlation Coefficient)
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Correlation between the LC-QSPECT measurements and bone turnover (Spearman Correlation Coefficient)
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Percentage of times that the use of the LC-QSPECT procedure resulted in any changes in treatment plans of the patients
Time frame: Through completion of Xofigo treatment (estimated to be 6 months)
Performance of the LC-QSPECT procedure using a no-gold-standard evaluation technique.
Time frame: Through completion of LC-QSPECT imaging (estimated to be 3 months)
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 15 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified SPECT imaging data, quantitative imaging metrics, and limited clinical variables (e.g., demographics, treatment cycle, administered activity, relevant lab values, clinical outcome measures) may be shared with qualified researchers at academic, nonprofit, or industry institutions for secondary analyses of image data, dosimetry, quantitative modeling, or clinical outcomes related to Radium-223 therapy.
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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.
Abhinav K Jha, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-count quantitative single-photon emission computed tomography imaging in people with Prostate Cancer and Cancer of the Prostate, run by Washington University School of Medicine at 1 site 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 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 1 site 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?
Contact Abhinav K Jha, Ph.D. (314-273-2655, a.jha@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spearman's correlation coefficient between the LC-QSPECT estimated uptake in the lesions and intestine with ex vivo activity sampling (time frame: Through collection of ex vivo sample (estimated to be 3 months)). 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 15 Oct 2026.