Ra-223 for Prostate Cancer

Overseen By Maya Aslam

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must be taking: Androgen inhibitors

Must not be taking: Taxane chemotherapy

Disqualifiers: Visceral metastases, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 6 months

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating prostate cancer that resists hormone therapy and spreads to the bones. The main goal is to determine if a PSMA PET scan can identify patients who will benefit most from Ra-223 radiation therapy. Ra-223 targets bone tumors by emitting radiation to kill cancer cells. The trial seeks men whose prostate cancer has spread to their bones and who have previously tried ineffective hormone treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any systemic anti-cancer therapy within 21 days before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that radium-223 (Ra-223) is generally well-tolerated by patients with prostate cancer that has spread to the bones. One study found Ra-223 to be safe, with most patients experiencing no severe side effects. The treatment is already approved for similar conditions, indicating its relative safety when used as directed.

Common side effects include mild to moderate issues like nausea, diarrhea, and low blood cell levels, which are usually manageable. Serious side effects are rare, but patients should still discuss potential risks with their healthcare providers. Overall, Ra-223 is a promising option for treating prostate cancer that has spread to the bones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radium-223 is unique because it specifically targets bone metastases in prostate cancer patients by mimicking calcium and delivering radiation directly to the affected areas in the bones. This targeted approach helps to minimize damage to surrounding healthy tissues, which is a significant advantage over more generalized radiation treatments. Researchers are excited about Radium-223 because it not only helps to control bone pain but also has the potential to improve overall survival rates, offering a promising option for patients with advanced prostate cancer.

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

Research has shown that Radium-223, which participants in this trial will receive, effectively treats prostate cancer that has spread to the bones and does not respond to hormone therapy. One study found that patients receiving Radium-223 lived for about 15.7 months on average, with half of the patients living longer. Previous research also demonstrated that Radium-223 helps delay bone problems and improves quality of life. When combined with other treatments like enzalutamide, Radium-223 can further extend the time patients live without their cancer worsening. Radium-223 is specifically approved for treating prostate cancer that has spread to the bones. ^{1 3 4 5 6}

Who Is on the Research Team?

Thomas A. Hope, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for men aged 18+ with castration-resistant prostate cancer that has spread to bones, but not beyond. They must have low testosterone levels and be in fairly good health overall. Participants need a positive PSMA PET scan result and can't have had certain previous cancer treatments or high bone involvement by the cancer.

Inclusion Criteria

For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration

My cancer is only in the bones, confirmed by a special PET scan.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I have undergone at least two cycles of chemotherapy that included a taxane.

My cancer has spread to my organs or brain/spine and hasn't been treated there.

I have previously been treated with specific radioactive medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

1 visit (in-person)

Treatment

Participants receive Ra-223 intravenously every 28 days for 6 cycles

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Every 3-6 months

Post-treatment Monitoring

Participants undergo PSMA PET/CT and blood sample collection

30-60 days after last dose

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PSMA Positron Emission Tomography (PET) Scan
• Radium-223

Trial Overview

The study tests if PSMA PET scans are effective in selecting patients who would benefit from Ra-223 radiation therapy. Ra-223 targets bone metastases from prostate cancer. The trial will assess how well this targeted radiation works after identifying tumor activity through advanced imaging techniques.

How Is the Trial Designed?

Group I: Treatment (NaF PET/CT/MDP, Ra-223, PSMA PET) Experimental Treatment 3 Interventions

Patients undergo NaF PET/CT or MDP scan within 45 days prior to cycle 1 day 1. Patients then receive standard of care Ra-223 IV on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo PSMA PET/CT over 45-60 minutes between 30-60 days after the last dose of Ra-223. Patients also undergo collection of blood samples during screening, on day 1 of every Ra-223 cycle, and at 30 days after the last dose of Ra-223. Patients may also undergo NaF PET/CT or MDP scans during Ra-223 treatment as clinically indicated, and/or CT scans during screening and Ra-223 treatment as clinically indicated.

Radium-223 is already approved in United States, European Union for the following indications:

Approved in United States as Xofigo for:

• Castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease

Approved in European Union as Xofigo for:

• Castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Industry Sponsor

Trials

28

Recruited

126,000+

Published Research Related to This Trial

Radium-223 dichloride is the first FDA-approved α-particle emitter for treating metastatic castrate-resistant prostate cancer (CRPC), showing benefits in overall survival and delaying skeletal-related events based on the phase III ALSYMPCA trial.

Current research is exploring Radium-223's effectiveness in earlier stages of cancer, its use in combination with other therapies, and its potential application in treating other cancers that have spread to bone, such as breast and renal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radium-223 Therapy for Patients with Metastatic Castrate-Resistant Prostate Cancer: An Update on Literature with Case Presentation. Nguyen, NC., Shah, M., Appleman, LJ., et al.[2020]

In a study of 20 patients with metastatic castrate-resistant prostate cancer (mCRPC) treated with Ra-223 dichloride, those with lower baseline PSA levels and fewer bone lesions had a higher likelihood of a favorable response to therapy, indicating better treatment outcomes.

The study found that 8 out of 20 patients showed improvement in pain and functional status after treatment, while 10 patients did not respond favorably, highlighting the importance of patient selection for optimizing Ra-223 therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can bone scans guide therapy with radium-223 dichloride for prostate cancer bone metastases? Gayed, I., Salama, V., Dawood, L., et al.[2023]

Radium-223 dichloride is a unique radiopharmaceutical that uses alpha-emission to effectively treat metastatic castrate resistant prostate cancer (mCRPC) with minimal side effects, particularly low myelosuppression.

Following the successful ALSYMPCA trial, radium-223 was FDA approved in 2013 for patients with mCRPC and symptomatic bone metastases, highlighting its efficacy in prolonging survival in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosing, administration, and safety of radium-223: How I do it. Dan, TD., Doyle, L., Raval, AJ., et al.[2018]

Radium-223 dichloride (Ra-223) is an effective treatment for patients with castration-resistant prostate cancer and symptomatic bone metastases, showing a 30% reduction in the risk of death compared to placebo.

Ra-223 is considered to have low toxicity, making it a safe option for patients, and it has been approved by both the FDA and EMA for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Alpha emitter radium-223 dichloride: new therapy in castration-resistant prostate cancer with symptomatic bone metastases]. Heinzer, H., König, F., Klutmann, S.[2021]

Radium-223 is the first targeted alpha therapy for patients with castration-resistant prostate cancer and symptomatic bone metastases, offering a new treatment option that requires careful management.

Expert recommendations from 11 nuclear medicine centres across six countries emphasize the importance of structured coordination and communication to optimize radium-223 treatment delivery and enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical recommendations for radium-223 treatment of metastatic castration-resistant prostate cancer. Du, Y., Carrio, I., De Vincentis, G., et al.[2023]

Radium-223 dichloride is a first-in-class radiopharmaceutical that significantly prolongs overall survival in patients with castration-resistant prostate cancer (CRPC) who have symptomatic bone metastases, based on findings from the Phase III ALSYMPCA trial.

The treatment has a favorable safety profile, with low rates of hematologic adverse events, making it a valuable option for both pre- and post-docetaxel settings in CRPC management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radium-223 dichloride for the treatment of bone metastatic castration-resistant prostate cancer: an evaluation of its safety. Nilsson, S.[2018]

Radium-223 dichloride (Xofigo®) has shown significant survival benefits for prostate cancer patients with bone metastases and a generally favorable safety profile, but its combination with abiraterone and prednisone may increase risks of death and fractures.

A retrospective analysis of approximately 1500 prostate cancer patients revealed that radium-223 can lead to hematological-related side effects, and its safety profile may vary when used with other treatments, highlighting the need for further studies to clarify its toxicological effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data. Soldatos, TG., Iakovou, I., Sachpekidis, C.[2020]

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Background: In the Phase 3 ALSYMPCA trial, radium-223 (Ra-223) demonstrated an overall survival (OS) benefit and a favorable safety profile ...