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Radioactive Compound

Dexamethasone + Radium-223 for Prostate Cancer (TRANCE Trial)

Phase 4
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG status ≤ 2
Rising PSA in combination with new metastases or evidence of radiographic disease progression despite castrate levels of testosterone while on androgen deprivation therapy (ADT) or following bilateral orchiectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through infusion completion, an average of 24 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing whether the addition of dexamethasone to radium-223 will help control PSA levels and reduce side effects during treatment in men with mCRPC.

Who is the study for?
This trial is for men with advanced prostate cancer that has spread to the bones and isn't responding to hormone therapy. They should have a PSA level of at least 2.0 ng/mL, be relatively active (ECOG ≤ 2), and may have pain or had radiotherapy for bone metastases. Their kidney and liver functions must meet certain criteria, like creatinine levels no more than 1.5 times the normal upper limit.
What is being tested?
The study tests if combining Radium-223, a radioactive drug given intravenously every four weeks for six cycles, with Dexamethasone, an anti-inflammatory oral medication, can better control PSA levels and reduce side effects in patients compared to Radium-223 alone.
What are the potential side effects?
Radium-223 can cause nausea, diarrhea, blood cell count changes leading to increased infection risk or bleeding problems. Dexamethasone might lead to increased blood sugar levels, mood swings, insomnia or weight gain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My prostate cancer is worsening despite low testosterone levels from treatment.
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I use pain medication for cancer pain or have had radiation for bone metastases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through infusion completion, an average of 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through infusion completion, an average of 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of total doses delivered on schedule

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Radium-223 with oral Dexamethasone 0.5 mgExperimental Treatment1 Intervention
Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment.
Group II: Standard of Care Radium-223Active Control1 Intervention
Radium-223 treatment will be administered as per standard of care.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,521 Previous Clinical Trials
503,240 Total Patients Enrolled
66 Trials studying Prostate Cancer
15,592 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,274 Previous Clinical Trials
25,532,627 Total Patients Enrolled
45 Trials studying Prostate Cancer
26,975 Patients Enrolled for Prostate Cancer
~3 spots leftby Nov 2025
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