Ra-223 for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Thomas A. Hope, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans (in combination with bone scans) work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started (primary site) to the bones (bone metastasis). Ra-223 is a type of therapy that emits radiation. Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells. Ra-223 is given by infusion into the veins, where it is absorbed by the bones. PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. A PET scan uses a special camera to detect the energy given off from radioactive tracers (such as PSMA) to make detailed pictures of areas where the tracer accumulates in the body. The PET scan is often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan, which helps to map the locations where PSMA has accumulated. PSMA PET scans may be able to select patients that will benefit the most from Ra-223 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.

What data supports the effectiveness of the drug Radium-223 dichloride (Xofigo) for prostate cancer?

Research shows that Radium-223 dichloride (Xofigo) can significantly prolong the life of patients with prostate cancer that has spread to the bones and is resistant to standard hormone therapy. It reduces the risk of death by 30% compared to a placebo and is approved by health authorities in the US and Europe for this use. ^{1 2 3 4 5}

Is Radium-223 safe for humans?

Radium-223, also known as Xofigo, is generally considered safe for treating prostate cancer with bone metastases, showing low toxicity and minimal side effects when used alone. However, combining it with other drugs like abiraterone and prednisone may increase the risk of death and fractures, so more studies are needed to fully understand its safety profile. ^{1 3 4 6 7}

What makes the drug Radium-223 unique for treating prostate cancer?

Radium-223 is unique because it is the first alpha-particle emitting drug approved for treating prostate cancer with bone metastases, specifically targeting cancer cells in the bones while sparing surrounding healthy tissue, which helps reduce the risk of death and delay bone-related symptoms. ^{1 2 3 4 5}

Research Team

Thomas A. Hope, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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 am a man aged 18 or older.

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.

Trial Timeline

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)

Treatment Details

Interventions

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

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, San Francisco San Francisco, CA

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2636

Patients Recruited

19,080,000+

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Industry Sponsor

Trials

28

Patients Recruited

126,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Alpha emitter radium-223 dichloride: new therapy in castration-resistant prostate cancer with symptomatic bone metastases]. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Egypt pubmed.ncbi.nlm.nih.gov

Radium-223 Therapy for Patients with Metastatic Castrate-Resistant Prostate Cancer: An Update on Literature with Case Presentation. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Practical recommendations for radium-223 treatment of metastatic castration-resistant prostate cancer. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Can bone scans guide therapy with radium-223 dichloride for prostate cancer bone metastases? [2023]

6. Switzerland 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. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Dosing, administration, and safety of radium-223: How I do it. [2018]