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Radioactive Compound

Dexamethasone plus 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
Clinical diagnosis of prostate cancer
ECOG status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through infusion completion, an average of 24 weeks
Awards & highlights

TRANCE Trial 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.Check my eligibility
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.See study design
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.

TRANCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate cancer.
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I can take care of myself and am up and about more than half of my waking hours.
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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.

TRANCE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of total doses delivered on schedule

TRANCE 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
1,456 Previous Clinical Trials
482,775 Total Patients Enrolled
64 Trials studying Prostate Cancer
15,440 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,229 Previous Clinical Trials
25,325,413 Total Patients Enrolled
39 Trials studying Prostate Cancer
25,919 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are involved in the current investigation?

"Absolutely. Per the information available on clinicaltrials.gov, this research is actively trying to acquire test subjects; initial postings were made on February 23rd 2018 and a recent update was done April 13th 2022. The requisite number of participants needed for this study is 24 from one single location."

Answered by AI

Is the combination of Dexamethasone and Radium-223 a safe approach for patients?

"After assessing the safety of Dexamethasone plus Radium-223, our team at Power awarded it a score of 3 out of 3 as this drug is already approved."

Answered by AI

What is the intended purpose of combining Dexamethasone and Radium-223 as a treatment?

"Ophthalmia, sympathetic ophthalmitis, eye inflammation and branch retinal vein occlusion can all be managed using a combination of Dexamethasone and Radium-223."

Answered by AI

Is this medical experiment accepting new participants at the moment?

"Indeed, the clinicaltrials.gov page confirms that this medical trial is still open to applicants and was last revised on April 13th 2022. Initially posted in February 2018, it aims to recruit 24 patients from 1 site."

Answered by AI

Are there any analogous studies that have combined Dexamethasone and Radium-223?

"Currently, 558 medical studies are being conducted to research the impact of Dexamethasone plus Radium-223. Of those studies, 144 reside in Phase 3 trials, with Mishawaka Indiana as their main base of operations. However, a total of 18710 locations worldwide are running clinical trials for this particular treatment."

Answered by AI
~3 spots leftby Mar 2025