CLINICAL TRIALS PROFILE FOR RADIUM RA-223 DICHLORIDE

All Clinical Trials for radium ra-223 dichloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00699751 ↗	A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases	Completed	Bayer	Phase 3	2008-06-01	ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.
NCT01516762 ↗	Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	No longer available	Bayer		1969-12-31	This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.
NCT01618370 ↗	Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases	Completed	Bayer	Phase 3	2012-07-22	This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.
NCT01810770 ↗	Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis	Completed	Bayer	Phase 3	2013-03-26	To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.
NCT01833520 ↗	Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma	Completed	Bayer	Phase 1/Phase 2	2013-10-16	The goal of this clinical research study is to find the highest tolerable dose of radium-223 dichloride that can be given to patients with osteosarcoma. Radium-223 chloride is designed to work like radiation therapy in cells that are actively making bone. It is designed to target new bone growth in and around bone cancer and may kill cancer cells.
NCT01833520 ↗	Phase I Dose Escalation of Monthly Intravenous Ra-223 Dichloride in Osteosarcoma	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	2013-10-16	The goal of this clinical research study is to find the highest tolerable dose of radium-223 dichloride that can be given to patients with osteosarcoma. Radium-223 chloride is designed to work like radiation therapy in cells that are actively making bone. It is designed to target new bone growth in and around bone cancer and may kill cancer cells.
NCT01934790 ↗	Re-treatment Safety of Radium-223 Dichloride in Castration-resistant Prostate Cancer With Bone Metastases	Completed	Bayer	Phase 1/Phase 2	2013-12-22	Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dichloride that led to the discontinuation of treatment. 40 Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg IV every 4 weeks. The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit every 4 weeks, prior to receiving radium-223 dichloride. After the end of treatment visit the subjects will enter the active follow up period. Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride. After the 2 years of active follow-up, subjects will enter the long-term follow-up period and will be followed via telephone follow-up at 6-month intervals for late toxicities and survival up to 7 years after the last dose of radium-223 dichloride or until death. Joint safety reviews will regularly take place to oversee safety of the subjects conducted at regular intervals. An interim analysis of the safety data will be conducted during the study.

Clinical Trial Conditions for radium ra-223 dichloride

Condition Name

Condition Name for radium ra-223 dichloride
Intervention	Trials
Prostatic Neoplasms	7
Prostate Cancer	4
Bone Metastases	4
Castration-Resistant Prostate Carcinoma	3

Condition MeSH

Condition MeSH for radium ra-223 dichloride
Intervention	Trials
Prostatic Neoplasms	25
Neoplasm Metastasis	8
Carcinoma	6
Adenocarcinoma	3

Clinical Trial Locations for radium ra-223 dichloride

Trials by Country

Trials by Country for radium ra-223 dichloride
Location	Trials
United States	251
Italy	75
United Kingdom	60
Germany	53
Spain	36

Trials by US State

Trials by US State for radium ra-223 dichloride
Location	Trials
California	17
New York	14
Pennsylvania	13
Michigan	12
Missouri	11

Clinical Trial Progress for radium ra-223 dichloride

Clinical Trial Phase

Clinical Trial Phase for radium ra-223 dichloride
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	15

Clinical Trial Status

Clinical Trial Status for radium ra-223 dichloride
Clinical Trial Phase	Trials
Completed	12
Recruiting	10
Active, not recruiting	4

Clinical Trial Sponsors for radium ra-223 dichloride

Sponsor Name

Sponsor Name for radium ra-223 dichloride
Sponsor	Trials
Bayer	19
National Cancer Institute (NCI)	5
Affiliated Hospital of Jiangnan University	2

Sponsor Type

Sponsor Type for radium ra-223 dichloride
Sponsor	Trials
Industry	26
Other	19
NIH	5

Radium ra-223 dichloride Market Analysis and Financial Projection

Radium-223 Dichloride: Clinical Trials, Market Analysis, and Projections

Introduction

Radium-223 dichloride, marketed as Xofigo, is a groundbreaking radiopharmaceutical used in the treatment of metastatic castration-resistant prostate cancer (mCRPC) with symptomatic bone metastases. Here, we delve into the latest clinical trials, market analysis, and future projections for this innovative drug.

Clinical Trials Overview

ALSYMPCA Trial

The pivotal Phase III ALSYMPCA trial was instrumental in the FDA approval of Radium-223. This trial compared Radium-223 to placebo in patients with mCRPC and symptomatic bone metastases but no visceral metastases. The results showed a significant improvement in median overall survival (14.9 months vs 11.3 months) and a reduction in the risk of death by 30%[1][3].

Ongoing and Future Trials

Several ongoing clinical trials are evaluating the efficacy and safety of Radium-223 in combination with other therapies. For example, the combination of Radium-223 with enzalutamide is being assessed in the PEACE III trial, showing promising safety and efficacy in men with mCRPC[1].

Another notable trial is the "Efficacy of Ra-223 in PSMA PET Optimally Selected Patients," which aims to determine the PSA50 response rate, median overall survival, and time to the first skeletal symptomatic event among other endpoints. This trial also explores the safety profile and lesion-based PSMA PET response[4].

Efficacy and Safety Profile

Survival Benefits

Radium-223 has consistently demonstrated survival benefits across various studies. The ALSYMPCA trial and subsequent real-world studies have shown that Radium-223 improves overall survival, with median survival ranging from 8.2 to 29 months depending on patient characteristics and treatment regimens[1][2].

Quality of Life and Symptomatic Relief

Patients treated with Radium-223 experience significant improvements in quality of life, as measured by FACT-P total score and EQ-5D. The drug also provides relief from bone pain and reduces the incidence of skeletal events[1][3].

Adverse Events

The most common adverse events associated with Radium-223 include bone pain, nausea, anemia, fatigue, and diarrhea. Despite these side effects, the overall incidence of adverse events is lower with Radium-223 compared to placebo, particularly for grade 3/4 and serious adverse events[1][3].

Market Analysis

Utilization and Cost

Since its approval, the utilization of Radium-223 has increased significantly. A retrospective study analyzing Medicare data from 2015 to 2017 found that the number of patients treated with Radium-223 increased by 43.4%, with CMS spending over $133 million during this period. Radiation oncologists manage the majority of Radium-223 infusions[5].

Cost-Effectiveness

The cost-effectiveness of Radium-223 varies by region and healthcare system. In China, for instance, Radium-223 is unlikely to be cost-effective at the current willingness-to-pay threshold, although it may be more viable in affluent areas with higher per-capita GDP. The incremental cost-effectiveness ratio (ICER) for Radium-223 compared to best standard care (BSC) was $85,647 per quality-adjusted life year (QALY)[2].

Market Projections

Growing Demand

The increasing incidence of prostate cancer and the growing awareness of targeted therapies are expected to drive the demand for Radium-223. As more patients are diagnosed with mCRPC, the market for this drug is likely to expand.

Combination Therapies

The ongoing trials evaluating Radium-223 in combination with other therapies, such as chemotherapy, immunotherapy, and targeted agents, could further enhance its market potential. Successful outcomes from these trials could lead to broader treatment indications and increased adoption[1].

Geographic Expansion

While Radium-223 is currently approved in several countries, there is potential for expansion into new markets. This could be particularly significant in regions with high healthcare spending and a strong focus on innovative cancer treatments.

Real-World Evidence and Optimization

Real-World Studies

Multiple real-world studies have confirmed the benefits observed in the ALSYMPCA trial. These studies suggest that the efficacy of Radium-223 can be optimized by using it in asymptomatic or minimally symptomatic patients, allowing for the completion of all six planned treatment cycles[1].

Patient Selection

Optimal patient selection, such as using PSMA PET to identify suitable candidates, is being explored to maximize the benefits of Radium-223. This approach could lead to better treatment outcomes and more efficient use of resources[4].

Key Takeaways

• Clinical Efficacy: Radium-223 significantly improves overall survival and quality of life in patients with mCRPC and symptomatic bone metastases.
• Safety Profile: The drug has a tolerable safety profile with common adverse events including bone pain, nausea, anemia, and fatigue.
• Market Growth: Increasing demand driven by growing incidence of prostate cancer and expanding treatment indications.
• Cost-Effectiveness: Varies by region; may be more viable in affluent areas with higher healthcare spending.
• Future Directions: Ongoing trials evaluating combination therapies and optimal patient selection could further enhance market potential.

FAQs

What is Radium-223 dichloride used for?

Radium-223 dichloride, marketed as Xofigo, is used for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have symptomatic bone metastases and no known visceral metastatic disease.

What were the key findings of the ALSYMPCA trial?

The ALSYMPCA trial showed that Radium-223 significantly improved median overall survival (14.9 months vs 11.3 months) and reduced the risk of death by 30% compared to placebo.

What are the common adverse events associated with Radium-223?

Common adverse events include bone pain, nausea, anemia, fatigue, and diarrhea, with a lower incidence of grade 3/4 and serious adverse events compared to placebo.

Is Radium-223 cost-effective?

The cost-effectiveness of Radium-223 varies by region. In some healthcare systems, it may not be cost-effective at current willingness-to-pay thresholds, but it could be more viable in affluent areas.

What ongoing trials are evaluating Radium-223?

Ongoing trials are evaluating Radium-223 in combination with other therapies such as chemotherapy, immunotherapy, and targeted agents, as well as its use in PSMA PET optimally selected patients.

How is Radium-223 administered?

Radium-223 is administered intravenously every 28 days for six cycles, unless disease progression or unacceptable toxicity occurs.

Sources

1. Radium-223: A Decade of Treating Metastatic Castration-Resistant Prostate Cancer. Sponsored by Harborside Studio.
2. Alpha emitter radium-223 in patients with metastatic castration-resistant prostate cancer: A cost-utility analysis. Frontiers in Pharmacology.
3. The New England Journal of Medicine Publishes Results from the Phase III ALSYMPCA Study of Xofigo® (radium Ra 223 dichloride) Injection. PR Newswire.
4. Efficacy of Ra-223 in PSMA PET Optimally Selected Patients. ClinicalTrials.gov.
5. Utilization and Cost of Radium-223 Dichloride (Xofigo®) for Metastatic Castration-Resistant Prostate Cancer. Journal of Nuclear Medicine.