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

January 23, 2024 updated by: University Health Network, Toronto

Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With Metastatic Castrate Resistant Prostate Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  1. Clinical diagnosis of prostate cancer
  2. ECOG status ≤ 2
  3. PSA ≥ 2.0 ng/mL
  4. 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
  5. Symptomatic disease defined as any analgesic use for pain or receipt of radiotherapy for bony metastatic disease

  6. 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

  7. Adequate hematologic function

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 100 g/L
  8. Evidence of bone metastasis on bone scan, CT, MRI or PET
  9. Life expectancy ≥ 6 months

EXCLUSION CRITERIA:

  1. Visceral metastatic PCa (brain, liver, lung, bulky adenopathy). Note that metastatic lymphadenopathy < 3cm is acceptable for inclusion as long as there is evidence of bone metastasis.
  2. Previous treatment with abiraterone, enzalutamide, docetaxel or other systemic chemotherapy for PCa
  3. Imminent spinal cord compression or history of spinal cord compression
  4. Previous treatment with systemic corticosteroids for PCa at any time
  5. Contraindication to receipt of systemic corticosteroids (i.e. uncontrolled diabetes)
  6. Prior or current enrolment in any other interventional clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care Radium-223
Radium-223 treatment will be administered as per standard of care.
Experimental: Radium-223 with oral Dexamethasone 0.5 mg
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
Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment.
Other Names:
  • Dexamethasone
  • Baycadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of total doses delivered on schedule
Time Frame: 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.
Through infusion completion, an average of 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Actual)

September 30, 2023

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-5196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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