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Radium-223

Phase 2

Prostate Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 28, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Radium-223 · 1 trial · 1 indication

Phase 2 1
NCT03093428Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPCProstate Cancer
COMPLETED45 Analytics
PHASE2COMPLETED
Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Increased Immune Cell Infiltration Across Arms
2 months

Differences in immune infiltrating cells (CD8+ T-cells and CD4+ T-cells) in bone biopsy specimens were compared from baseline to 8 weeks on study therapy between the treatment arms.

Secondary Endpoints

Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
Toxicity was assessed every cycle and up to 22.4 months.
Median Progression-Free Survival
Imaging was performed every 12 weeks and up to 25 months.
Median Overall Survival
Participants were followed up for ~36 months.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pembrolizumab Plus Radium-223EXPERIMENTAL* Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose * Pembrolizumab will be administered intravenously every 3 weeks at a pre-determined dose Radium-223 will be halted after 3 doses. Once radiographic progressive disease occurs, the last 3 doses of radium will be given.
Radium-223EXPERIMENTAL\- Radium-223 will be administered intravenously every 4 weeks at a pre-determined dose

Interventions

NameTypeDescription
Radium-223DRUGRadium-223 is a calcium mimetic that hones in on bone metastases. It binds to new bone stroma and emits alpha particles, which induce double-stranded DNA breaks that result in tumor cell death.
PembrolizumabDRUGPembrolizumab is a PD-1 inhibitor. Pembrolizumab binds to human PD-1 and blocks the interaction between PD1 and its ligands.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Castration-resistant prostate cancer requires the following 3 criteria: * Progression after surgical castration or on GnRH agonist or antagonist * A castrate level of testosterone (\<50ng/dL) * Prostate cancer pr...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about Radium-223

What is Radium-223 used for in prostate cancer?

Radium-223 is an investigational small molecule being studied for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer (mCRPC). It is being evaluated in combination with pembrolizumab in a Phase 2 clinical trial. The drug is not yet approved and remains in clinical development.

What does Radium-223 target?

Radium-223 is a small molecule that emits alpha particles, which target and damage cancer cells in bone metastases. It is being studied in prostate cancer, where it is thought to deliver radiation directly to bone lesions, potentially reducing tumor growth and symptoms.

Who makes Radium-223?

Radium-223 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the drug's safety and efficacy in prostate cancer.

What phase is Radium-223 in?

Radium-223 is currently in Phase 2 clinical development for prostate cancer. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is evaluating the drug in combination with pembrolizumab in patients with metastatic castration-resistant prostate cancer.

What clinical trials is Radium-223 in?

Radium-223 is being studied in a Phase 2 clinical trial with the identifier NCT03093428, titled 'Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC.' This completed trial enrolled 45 male patients aged 18 years and older with prostate cancer in the United States.

Is Radium-223 the same as Xofigo?

Radium-223 is also known as Xofigo, a brand name for the drug. In clinical trials, it is referred to as radium-223 dichloride. The drug is being studied for prostate cancer and is currently in Phase 2 development by Merck & Company, Inc.