Prednisone/Prednisolone for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prostate CancerPrednisone/Prednisolone - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02741271) in the MF MDI 100 mcg BID ARM group. Side effects include: Asthma with 16%, Nasopharyngitis with 9%, Pharyngitis with 7%, Rhinitis with 6%, Influenza with 3%.

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