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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT03432949
Collaborator
Bayer (Industry)
24
1
2
57.7
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone plus Radium-223
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With Metastatic Castrate Resistant Prostate Cancer
Actual Study Start Date :
Feb 23, 2018
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    1. Adequate hematologic function
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

    • Platelet count ≥ 100 x 109/L

    • Hemoglobin ≥ 100 g/L

    1. Evidence of bone metastasis on bone scan, CT, MRI or PET

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada

    Sponsors and Collaborators

    • University Health Network, Toronto
    • Bayer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT03432949
    Other Study ID Numbers:
    • 17-5196
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by University Health Network, Toronto
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 15, 2022