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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 : March 23, 2018
Sponsor:
Collaborator:
Bayer Yakuhin, Ltd.
Information provided by (Responsible Party):
Taro Iguchi, MD, PHD, 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

Condition or disease Intervention/treatment Phase
Castration-resistant Prostate Cancer Bone Metastases Drug: Ra-223 in combination with enzalutamide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Combination Therapy With Radium-223 and Enzalutamide in Osaka City University
Actual Study Start Date : October 27, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ra-223 + Enzalutamide 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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Tolerability of Radium-223 therapy [ Time Frame: 6 months ]
    Proportion of patients who complete 6 times injections of radium-223

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. Changes in Prostate Specific Antigen (PSA) [ Time Frame: 6 months ]
    Percent change in prostate-specific antigen (PSA) from baseline at 6 months.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03305224


Contacts
Contact: Taro Iguchi, MD, PhD +81-6-6645-3857 taro@msic.med.osaka-cu.ac.jp

Locations
Japan
Osaka City University Graduate School of Medicine Recruiting
Osaka, Japan, 545-8585
Contact: Taro Iguchi, MD, PhD         
Sponsors and Collaborators
Taro Iguchi, MD, PHD
Bayer Yakuhin, Ltd.

Responsible Party: Taro Iguchi, MD, PHD, Principal Investigator, Osaka City University
ClinicalTrials.gov Identifier: NCT03305224     History of Changes
Other Study ID Numbers: CORE-OCU
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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 Taro Iguchi, MD, PHD, Osaka City University:
castration-resistant prostate cancer
bone metastasis

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes