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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03432949
Study type	Interventional
Source	University Health Network, Toronto
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	February 23, 2018
Completion date	July 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms