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

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ClinicalTrials.gov Identifier: NCT03432949
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: Dexamethasone plus Radium-223 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 23, 2018
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432949


Contacts
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Contact: Heidi Wagner 416-946-4501 ext 2354 heidi.wagner@uhn.ca
Contact: Miran Kenk 416-946-4501 ext 3431 miran.kenk@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Heidi Wagner    416-946-4501 ext 2354    heidi.wagner@uhn.ca   
Principal Investigator: Neil Fleshner, MD         
Sub-Investigator: Nathan Perlis, MD         
Sub-Investigator: Robert Hamilton, MD         
Sub-Investigator: Girish Kulkarni, MD         
Sub-Investigator: Alexandre Zlotta, MD         
Sub-Investigator: Antonio Finelli, MD         
Sub-Investigator: Srikala Sridhar, MD         
Sponsors and Collaborators
University Health Network, Toronto
Bayer

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03432949     History of Changes
Other Study ID Numbers: 17-5196
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Radium-223
Dexamethasone
mCRPC

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action