Radium-223 for Prostate Cancer

AK
Overseen ByAbhinav K Jha, Ph.D.
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Washington University School of Medicine
Must be taking: Xofigo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new imaging technique called LC-QSPECT to assess its effectiveness in tracking the distribution of Radium-223, a treatment for prostate cancer that has spread to bones. The goal is to better understand how this treatment spreads throughout the body, which can help personalize doses and improve overall treatment. This trial may be suitable for individuals with prostate cancer that does not respond to hormone therapy and has spread to the bones. Participants will undergo imaging and provide samples to assist researchers in gathering data. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to more personalized and effective treatments for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are using other radiopharmaceuticals at the same time.

What prior data suggests that LC-QSPECT imaging is safe for patients with prostate cancer?

Research has shown that Radium-223, also known as Xofigo, is generally safe for patients with prostate cancer that has spread to the bones. It has been used safely in many patients, with some followed for up to 95 months, and most did not experience serious side effects. One study found it effective and well-tolerated by Taiwanese patients with similar conditions.

The FDA has approved Radium-223 for treating prostate cancer that has spread to the bones, further suggesting its safety. While it is known to be effective, like any treatment, it can have side effects. Overall, research supports the safety of Radium-223 for use in people.12345

Why are researchers excited about this trial?

Most treatments for prostate cancer, such as hormone therapy or chemotherapy, aim to slow cancer growth or alleviate symptoms. But Radium-223 works differently, targeting cancerous bone metastases directly with radiation. This treatment is unique because it mimics calcium and integrates into the bone, delivering targeted radiation to kill cancer cells while sparing surrounding healthy tissue. Researchers are excited about Radium-223 because it offers a more precise approach, potentially reducing side effects and improving quality of life for patients with advanced prostate cancer.

What evidence suggests that Radium-223 might be an effective treatment for prostate cancer?

Research has shown that Radium-223 effectively treats prostate cancer that has spread to the bones. One study found that patients treated with Radium-223 lived for an average of 15.7 months, longer than with some other treatments. Another study demonstrated that Radium-223 not only extended patients' lives but also reduced their pain. It works by delivering radiation directly to the bones, targeting cancer cells while leaving healthy tissue mostly unharmed. This targeted approach makes it a valuable option for men with advanced prostate cancer that has spread to the bones. Participants in this trial will receive Radium-223 as part of the standard of care, with additional monitoring through noninvasive LC-QSPECT scans and other assessments.23467

Who Is on the Research Team?

AK

Abhinav K Jha, Ph.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for men with bone metastatic castration-resistant prostate cancer who have been treated with Radium-223. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to give informed consent.

Inclusion Criteria

Patients must have a minimum detectable skeletal lesion count of 3
My prostate cancer is resistant to hormone therapy and has spread to my bones, causing symptoms.
I am eligible to receive Xofigo treatment.
See 3 more

Exclusion Criteria

My cancer has mainly spread to the organs in my body.
I have or had another cancer that won't affect this trial's treatment.
I do not have any uncontrolled illnesses like heart problems or infections.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care Xofigo treatment with LC-QSPECT imaging and additional assessments

6 months
Visits at baseline, after Cycles 1, 3, and 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Radium-223
Trial Overview The study tests the feasibility of using low-count quantitative SPECT imaging to monitor how a radiopharmaceutical therapy called Xofigo distributes in the body and localizes in diseased cells versus normal tissues.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: LC-QSPECTExperimental Treatment1 Intervention
Group II: PhysiciansActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38924042/
Real-world safety and effectiveness of radium-223 in ...Median OS was 15.7 months (95% confidence interval 12.13-19.51); patients receiving 5-6 223Ra injections and earlier 223Ra use had longer OS ...
Effectiveness and safety of radium-223 in men with ...12 studies reporting pain outcomes showed a reduction in pain with varying magnitude. Of 13 studies reporting grade 3+ myelosuppression, ...
Clinical outcomes and treatment patterns in REASSURERadium-223 is a targeted alpha therapy approved for the treatment of castration-resistant prostate cancer (CRPC) with bone metastases based on ...
ASCO 2025: XOFIGO® (radium-223 dichloride) Combination ...The results demonstrated that the addition of XOFIGO to enzalutamide significantly increased radiological progression-free survival (rPFS) among ...
Treatment outcomes with radium-223 in patients ...In the Alpharadin in Symptomatic Prostate Cancer trial, the median OS in the Ra-223 treatment group was 14.9 months, significantly longer than the 11.3 months ...
Long-term safety of radium-223 (Ra-223) in metastatic ...Results: Analyses included 1472 pts; median follow-up was 17 months (range 0.3–95.4). Median age was 73 years and 80% of pts had an ECOG PS of 0 ...
New XOFIGO® (radium-223 dichloride) Data in Metastatic ...XOFIGO® in combination with enzalutamide significantly increased radiological progression-free survival for patients with prostate cancer.
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