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

NCT03432949 | Unknown Phase 4

• 1 other identifier: 17-5196
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Cancer

Keywords

Radium-223; Dexamethasone; mCRPC

Outcome Measures

Primary Outcomes (1)

• Percentage of total doses delivered on schedule

  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.

  Through infusion completion, an average of 24 weeks

Study Arms (2)

Standard of Care Radium-223

NO INTERVENTION

Radium-223 treatment will be administered as per standard of care.

Radium-223 with oral Dexamethasone 0.5 mg

EXPERIMENTAL

Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment.

Drug: Dexamethasone plus Radium-223

Interventions

Dexamethasone plus Radium-223 DRUG

Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment.

Also known as: Dexamethasone, Baycadron

Radium-223 with oral Dexamethasone 0.5 mg

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of prostate cancer
• ECOG status ≤ 2
• PSA ≥ 2.0 ng/mL
• 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
• Symptomatic disease defined as any analgesic use for pain or receipt of radiotherapy for bony metastatic disease
• Adequate renal and hepatic function:
• Cr ≤ 1.5 x upper limit of normal (ULN)
• AST ≤ 2.5 x ULN
• ALT ≤ 2.5 x ULN
• Albumin \> 25 g/L
• Total bilirubin ≤ 1.5 x ULN
• Adequate hematologic function
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x 109/L
• Hemoglobin ≥ 100 g/L

You may not qualify if:

• Previous treatment with abiraterone, enzalutamide, docetaxel or other systemic chemotherapy for PCa
• Imminent spinal cord compression or history of spinal cord compression
• Previous treatment with systemic corticosteroids for PCa at any time
• Contraindication to receipt of systemic corticosteroids (i.e. uncontrolled diabetes)
• Prior or current enrolment in any other interventional clinical trial

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Bayer: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dexamethasone; Radium-223; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 14, 2018
• Study Start: February 23, 2018
• Primary Completion: September 30, 2023
• Study Completion: July 30, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)