Study Summary
This trial is testing if adding radium-223 dichloride to standard treatment can prolong life and delay specific events related to prostate cancer that has spread to the bone.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: From start of study treatment until 4 weeks after last study treatment, up to 65 months
Month 46
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
Number of Participants With Post-treatment Adverse Events
Number of Participants With Post-treatment Bone Fractures
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Month 67
Overall Survival (OS)
Month 47
Symptomatic Skeletal Event Free Survival (SSE-FS)
Month 47
Radiological Progression Free Survival (rPFS)
Month 47
Time to Cytotoxic Chemotherapy
Month 47
Time to Opiate Use for Cancer Pain
Month 47
Time to Pain Progression
Month 65
Number of Participants With Any Treatment-emergent Additional Primary Malignancies
Number of Participants With Treatment-emergent Bone Fractures
Month 65
Number of Participants With Treatment-emergent Adverse Events
Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
MF MDI 100 mcg BID
16%Asthma
9%Nasopharyngitis
7%Pharyngitis
6%Rhinitis
3%Influenza
3%Upper respiratory tract infection
1%Epididymitis
Trial Design
2 Treatment Groups
Radium-223 dichloride + Abi/Pred
1 of 2
Placebo + Abi/Pred
1 of 2
Experimental Treatment
Non-Treatment Group
806 Total Participants · 2 Treatment Groups
Primary Treatment: Prednisone/Prednisolone · Has Placebo Group · Phase 3
Radium-223 dichloride + Abi/PredExperimental Group · 3 Interventions: Prednisone/Prednisolone, Abiraterone, Radium-223 dichloride (Xofigo, BAY88-8223) · Intervention Types: Drug, Drug, Drug
Placebo + Abi/PredPlaceboComparator Group · 3 Interventions: Prednisone/Prednisolone, Abiraterone, Matching placebo (normal saline) · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisolone
FDA approved
Abiraterone
FDA approved
Radium Ra 223 dichloride
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from start of study treatment until 4 weeks after last study treatment, up to 65 months
Who is running the clinical trial?
BayerLead Sponsor
2,154 Previous Clinical Trials
23,884,608 Total Patients Enrolled
36 Trials studying Prostate Cancer
25,162 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLCIndustry Sponsor
925 Previous Clinical Trials
6,345,323 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Bayer Study DirectorStudy DirectorBayer
1,180 Previous Clinical Trials
4,261,455 Total Patients Enrolled
6 Trials studying Prostate Cancer
1,927 Patients Enrolled for Prostate Cancer
Eligibility Criteria
Age 18+ · Male Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a performance status of 0 or 1.
You are male and of age ≥ 18 years.
References
- Smith, Matthew, Chris Parker, Fred Saad, Kurt Miller, Bertrand Tombal, Quan Sing Ng, Martin Boegemann, et al.. 2019. “Addition of Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone in Patients with Castration-resistant Prostate Cancer and Bone Metastases (ERA 223): A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(18)30860-x.
- Shore, Neal, Celestia S. Higano, Daniel J. George, Cora N. Sternberg, Fred Saad, Bertrand Tombal, Kurt Miller, et al.. 2020. “Concurrent or Layered Treatment with Radium-223 and Enzalutamide or Abiraterone/prednisone: Real-world Clinical Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer”. Prostate Cancer and Prostatic Diseases. Springer Science and Business Media LLC. doi:10.1038/s41391-020-0236-0.
- Matsubara, Nobuaki, Go Kimura, Hiroji Uemura, Hirotsugu Uemura, Motonobu Nakamura, Satoshi Nagamori, Atsushi Mizokami, et al.. 2019. “A Randomized, Double-blind, Comparison of Radium-223 and Placebo, in Combination with Abiraterone Acetate and Prednisolone, in Castration-resistant Metastatic Prostate Cancer: Subgroup Analysis of Japanese Patients in the ERA 223 Study”. International Journal of Clinical Oncology. Springer Science and Business Media LLC. doi:10.1007/s10147-019-01589-6.
- Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nole F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6. Erratum In: Lancet Oncol. 2019 Oct;20(10):e559.
- 2014. "Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02043678.
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Conditions
Cancer Related
Treatments