Radium-223 + Docetaxel for Prostate Cancer

Recruiting at 81 trial locations

Overseen By Josef Fox, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: LHRH analogues

Must not be taking: 5-alpha-reductase inhibitors

Disqualifiers: Visceral metastases, Active second malignancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 10

Duration: 30 weeks

738 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining radium-223 with docetaxel (a chemotherapy drug) is more effective for prostate cancer than using docetaxel alone. Researchers aim to determine if the combination better slows or stops cancer that has become resistant to castration (a common treatment). Men with prostate cancer that has progressed despite previous treatments and who have at least two bone lesions might be suitable for this trial. Participants will receive either the combination of the two drugs or docetaxel alone to compare the effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain treatments like investigational agents, external beam radiotherapy, or specific supplements within 4 weeks before joining. It's best to discuss your current medications with the trial team.

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

Research has shown that both docetaxel alone and the combination of radium-223 with docetaxel have been studied for safety in prostate cancer patients. In a study on docetaxel, it was generally well-tolerated, though some patients experienced side effects like febrile neutropenia, a fever with a low white blood cell count, leading to hospital stays. This occurred in about 34% of patients.

Previous research suggests that the combination of radium-223 with docetaxel is also well-tolerated and has shown promising results without major safety concerns. Radium-223 alone has been approved since 2013 for treating a type of prostate cancer that has spread to bones, indicating a good understanding of its safety from past use.

Overall, past research has considered both treatments safe, but it is important to be aware of possible side effects and discuss these with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Radium-223 with Docetaxel for prostate cancer because it offers a novel approach to treatment. While standard care often involves chemotherapy with drugs like Docetaxel alone, this treatment introduces Radium-223, a radioactive substance that specifically targets bone metastases, which are common in advanced prostate cancer. This dual approach not only attacks cancer cells with chemotherapy but also delivers targeted radiation, potentially reducing tumor growth more effectively. The hope is that this combination will enhance treatment efficacy and improve patient outcomes compared to existing therapies.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that docetaxel, one of the treatments in this trial, effectively treats prostate cancer. Studies indicate it significantly lowers the risk of death in patients and is generally well-tolerated. It works well for both hormone-responsive and hormone-resistant prostate cancer.

Another treatment arm in this trial combines docetaxel with radium-223. Early studies have shown promise for this combination. Radium-223 targets cancer cells in the bones, where prostate cancer often spreads. Initial findings suggest this combination might be more effective than using each treatment alone, but further research is needed to confirm these results. ^{2 3 6 7 8}

Who Is on the Research Team?

Michael Morris, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for males over 18 with progressive prostate cancer, who have not had certain recent treatments or a second active malignancy. They must have normal organ function, agree to birth control measures, and be willing to follow the study protocol.

Inclusion Criteria

Willing and able to comply with the protocol, including follow-up visits and examinations

Any side effects from my previous treatments are mild.

My cancer has grown by 20% or more, or I have new cancer spots since starting treatment.

Exclusion Criteria

I have swelling in my groin, penis, or legs due to cancer.

I haven't taken any experimental cancer treatments or other cancer therapies in the last 4 weeks.

I have severe urinary or rectal symptoms due to my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive docetaxel chemotherapy with or without radium-223

30 weeks

10 visits (in-person, every 3 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Radium-223

Trial Overview The study tests if combining Radium-223 with Docetaxel chemotherapy is more effective than using Docetaxel alone in treating prostate cancer. Participants will receive one of these treatment regimens to compare outcomes.

How Is the Trial Designed?

Group I: Docetaxel with Radium-223 Experimental Treatment 2 Interventions

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

Group II: Docetaxel Experimental Treatment 1 Intervention

Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

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 (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 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]

In a study involving 921 patients with castration-resistant prostate cancer and symptomatic bone metastases, radium-223 significantly improved health-related quality of life (QOL) compared to placebo, with 29.2% of patients experiencing meaningful improvement in QOL scores versus 18.5% in the placebo group.

Radium-223 not only enhanced survival rates but also resulted in a slower decline in QOL over time, indicating that it provides both therapeutic and quality of life benefits for patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study. Nilsson, S., Cislo, P., Sartor, O., et al.[2022]

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]

In a study of 36 patients with castration-resistant prostate cancer and bone metastasis, using Radium-223 (Ra-223) therapy before docetaxel (DOC) resulted in a significantly higher treatment completion rate (94% vs. 52%) and longer progression-free survival (8 months vs. 5 months).

Patients receiving Ra-223 before DOC also experienced longer cause-specific survival (32 months vs. 15 months), suggesting that Ra-223 is more effective and potentially safer when administered prior to DOC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Radium-223 for Castration-resistant Prostate Cancer With Bone Metastasis Before and After Docetaxel. Okabe, KO., Terada, N., Shirakawa, T., et al.[2022]

The combination of radium-223 and docetaxel was found to be well tolerated in patients with bone-predominant metastatic castration-resistant prostate cancer, with a recommended phase 2 dose established for future studies.

Patients receiving the combination treatment showed a longer median time to progression of prostate-specific antigen levels compared to those on docetaxel alone, suggesting enhanced antitumor activity from the combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial. Morris, MJ., Loriot, Y., Sweeney, CJ., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40276087/

Real‑world data on the outcomes of upfront docetaxel in ... The present study demonstrated that upfront docetaxel chemotherapy may be an effective and tolerable treatment for hormone-sensitive metastatic ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589004225005103

Article Real-world effectiveness of novel hormonal agents ... Our results indicate that patients treated with NHAs experience comparable OS and PSA-PFS to those treated with docetaxel, yet they require less ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811171

Mortality Risk for Docetaxel-Treated, High-Grade Prostate ... Adding docetaxel to SOC treatment in patients who were in otherwise good health was associated with a significant reduction in death due to prostate cancer.

4. spandidos-publications.com spandidos-publications.com/10.3892/ol.2025.15046

Real‑world data on the outcomes of upfront docetaxel ... The present study demonstrated that upfront docetaxel chemotherapy may be an effective and tolerable treatment for hormone‐sensitive metastatic prostate cancer.

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14575-1

Assessing the clinical outcomes of immunotherapy and ... Assessing the clinical outcomes of immunotherapy and docetaxel combinations in metastatic castration-resistant prostate cancer: a meta-analysis.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28940952/

Real-world uptake, safety profile and outcomes of ... Results: Of the 270 eligible patients, 103 received docetaxel (38.1%). 35 patients (34%) were hospitalised and there were 17 episodes of febrile neutropenia ( ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109422000422

Long-Term Outcomes of a Phase I Trial of Weekly ... This regimen produced a 10-year overall survival of 68% with a 10-year metastasis-free survival of 58%. Grade >2 toxicity was minimal.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.18.02158

The Randomized Phase III NRG Oncology RTOG 0521 Trial CT with docetaxel improved OS from 89% to 93% at 4 years, with improved disease-free survival and reduction in the rate of distant metastasis.