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The Combination Therapy With Ra-223 and Enzalutamide (CORE-OCU)

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ClinicalTrials.gov Identifier: NCT03305224
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Bayer Yakuhin, Ltd.
Information provided by (Responsible Party):
Taro Iguchi, MD, PHD, Osaka City University

Tracking Information
First Submitted Date  ICMJE August 28, 2017
First Posted Date  ICMJE October 9, 2017
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE October 27, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
Changes in Alkaline phosphatase (ALP) [ Time Frame: 6 months ]
Percentage of change from baseline to 6 months (or earlier for those who discontinue study therapy)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • Tolerability of Radium-223 therapy [ Time Frame: 6 months ]
    Proportion of patients who complete 6 times injections of radium-223
  • Evaluation for bone metastasis by 18F-NaF-PET [ Time Frame: 1, 3, 6 months ]
    Fractional decline of intensity of tracer uptake measured by SUVmax on 18F-NaF-PET at 1, 3, 6 months.
  • Evaluation for bone metastasis by bone scintigraphy [ Time Frame: 1, 3, 6 months ]
    The change of Bone Scan Index (BSI) by bone scintigraphy at 1, 3, 6 months.
  • Overall Survival Rate [ Time Frame: 3 years ]
    Overall Survival (OS) is defined as the time from the registration to death due to any cause, or censored at date last known alive.
  • Time to occurrence of Symptomatic Skeletal-related Events (SSEs) [ Time Frame: 1 year ]
    Time to occurrence of SSEs are defined asthe time from registration to the date of the occurrence of SSEs (symptomatic fracture, surgery or radiation to bone, or spinal cord compression).
  • Time to occurrence of visceral metastasis [ Time Frame: 1 year ]
    Time to occurrence of visceral metastasis was defined as the time from registration to the date of the occurrence of a visceral metastasis for each patient.
  • Time to initiation of cytotoxic chemotherapy [ Time Frame: 1 year ]
    The time to initiation of cytotoxic chemotherapy is defined as the time from registration to the date of initiation of cytotoxic chemotherapy.
  • Changes in Prostate Specific Antigen (PSA) [ Time Frame: 6 months ]
    Percent change in prostate-specific antigen (PSA) from baseline at 6 months.
  • Changes From Baseline for Brief Pain Inventory (BPI) [ Time Frame: 6 months ]
    The change for the BPI-SF (Brief Pain Inventory-Short Form) score was calculated.
  • Changes From Baseline for Functional Assessment of Cancer Therapy - Prostate (FACT-P) [ Time Frame: 6 months ]
    The change for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated.
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 6 months ]
    Number of participants with adverse events as a measure of safety and tolerability.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Combination Therapy With Ra-223 and Enzalutamide
Official Title  ICMJE The Study of Combination Therapy With Radium-223 and Enzalutamide in Osaka City University
Brief Summary This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Castration-resistant Prostate Cancer
  • Bone Metastases
Intervention  ICMJE Drug: Ra-223 in combination with enzalutamide
Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with enzalutamide 160 mg per a day
Study Arms  ICMJE Ra-223 + Enzalutamide
Intervention: Drug: Ra-223 in combination with enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients diagnosed as CRPC
  2. Surgical or those who will be treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period,
  3. Patients who had >30% of PSA response to enzalutamide prior to enrollment,
  4. Interval between PSA progression and enrollment is up to 3 months,
  5. With bone metastases (≥ 2 hot spots) on bone scintigraphy within previous 24 weeks,
  6. No intention to use anti-cancer chemotherapy within the next 6 months,
  7. Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1,
  8. Life expectancy ≥ 6 months,
  9. Laboratory requirements within 30 days before enrollment:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L,
    • Platelet count ≥ 100 x 10e9/L,
    • Hemoglobin ≥ 10.0 g/dL,
    • Total bilirubin level ≤1.5 institutional upper limit of normal (ULN),
    • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 ULN,
    • Creatinine ≤ 1.5ULN, and estimated glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2,
  10. Age ≥ 20,
  11. Ability to understand and the willingness to sign a written informed consent (IC).

Exclusion Criteria:

  1. Prior chemotherapy or planned treatment with chemotherapy,
  2. PSA progression within 3 months after initiation of enzalutamide
  3. Prior treatment with corticosteroids, estramustine or abiraterone acetate,
  4. Any systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases,
  5. Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry,
  6. History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations,
  7. History of or known brain metastasis,
  8. Malignant lymphadenopathy ≧1.5 cm in short axis,
  9. Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging),
  10. Any other serious illness or medical condition
  11. Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study Results
  12. Those who judged to be inappropriate by the principal investigator or co-investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Taro Iguchi, MD, PhD +81-6-6645-3857 taro@msic.med.osaka-cu.ac.jp
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03305224
Other Study ID Numbers  ICMJE CORE-OCU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taro Iguchi, MD, PHD, Osaka City University
Study Sponsor  ICMJE Taro Iguchi, MD, PHD
Collaborators  ICMJE Bayer Yakuhin, Ltd.
Investigators  ICMJE Not Provided
PRS Account Osaka City University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP