Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With M+CRPC

Phase 4

Active, not recruiting

• Conditions: Metastatic Prostate Cancer
• Interventions: Drug: Dexamethasone plus Radium-223

• Registration Number: NCT03432949
• Lead Sponsor: University Health Network, Toronto

Brief Summary

More than 90% of patients with metastatic castration-resistant prostate cancer (mCRPC) no longer responding to androgen deprivation hormonal therapy have evidence of bone metastases. This is a major cause of death, disability, and decreased quality of life.

Radium-223 is radiopharmaceutical meaning that the drug is a radioactive compound used for therapeutic purposes. It is given intravenously (through a vein) every 4 weeks for 6 cycles. Research has demonstrated safety and efficacy in mCRPC patients resulting in radium-223 becoming a standard of care option for such patients in addition to chemotherapy and new oral hormonal drugs enzalutamide or abiraterone.

Prior research studies using radium-223 have shown improved survival in about 30% of patients. The same studies in combination with data collected from clinical use have also shown that between 20 and 50% of men do not complete the full 6 cycle course of treatment due to side effects or a rise in prostate specific antigen (PSA) requiring the stoppage of radium-223 therapy to start one of the other drug therapies.

The purpose of this study is to determine whether an oral drug called dexamethasone (a corticosteroid) given together with radium-223 may control PSA levels and reduce side effects during radium-223 treatment. Corticosteroids are anti-inflammatory medicines prescribed for a broad range of conditions and are widely used in conjunction with chemotherapy treatments for cancer. Prior research studies have shown that dexamethasone reduces PSA levels by lowering the production of androgens (i.e. male hormones) and improves overall tolerance for cancer-fighting drugs and therapies.

Up to 24 men being treated with radium-223 at University Health Network will be enrolled into this study. If the study is positive, it might offer an improved quality of life and extended survival.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-14
• Study Start: 2018-02-23
• Primary Completion: 2023-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radium-223 with oral Dexamethasone 0.5 mg	Dexamethasone plus Radium-223	Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment.

Primary Outcome Measures

Name	Time	Method
Percentage of total doses delivered on schedule	Through infusion completion, an average of 24 weeks	To assess the feasibility of delivering 6-treatment cycles of Radium-223 without delays when administered in combination with low-dose oral dexamethasone for patients with metastatic CRPC and bony metastases who are abiraterone, enzalutamide and systemic chemotherapy naïve.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada