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

Primary Purpose

Castration-resistant Prostate Cancer, Bone Metastases

Status

Unknown status

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Ra-223 in combination with enzalutamide

About this trial

This is an interventional treatment trial for Castration-resistant Prostate Cancer focused on measuring castration-resistant prostate cancer, bone metastasis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients diagnosed as CRPC
Surgical or those who will be treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period,
Patients who had >30% of PSA response to enzalutamide prior to enrollment,
Interval between PSA progression and enrollment is up to 3 months,
With bone metastases (≥ 2 hot spots) on bone scintigraphy within previous 24 weeks,
No intention to use anti-cancer chemotherapy within the next 6 months,
Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1,
Life expectancy ≥ 6 months,
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,
Age ≥ 20,
Ability to understand and the willingness to sign a written informed consent (IC).

Exclusion Criteria:

Prior chemotherapy or planned treatment with chemotherapy,
PSA progression within 3 months after initiation of enzalutamide
Prior treatment with corticosteroids, estramustine or abiraterone acetate,
Any systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases,
Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry,
History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations,
History of or known brain metastasis,
Malignant lymphadenopathy ≧1.5 cm in short axis,
Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging),
Any other serious illness or medical condition
Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study Results
Those who judged to be inappropriate by the principal investigator or co-investigator.

Sites / Locations

Osaka City University Graduate School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ra-223 + Enzalutamide

Arm Description

Outcomes

Primary Outcome Measures

Changes in Alkaline phosphatase (ALP)

Percentage of change from baseline to 6 months (or earlier for those who discontinue study therapy)

Secondary Outcome Measures

Tolerability of Radium-223 therapy

Proportion of patients who complete 6 times injections of radium-223

Evaluation for bone metastasis by 18F-NaF-PET

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

The change of Bone Scan Index (BSI) by bone scintigraphy at 1, 3, 6 months.

Overall Survival Rate

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 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 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

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)

Percent change in prostate-specific antigen (PSA) from baseline at 6 months.

Changes From Baseline for Brief Pain Inventory (BPI)

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)

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)

Number of participants with adverse events as a measure of safety and tolerability.

Full Information

NCT ID

NCT03305224

First Posted

August 28, 2017

Last Updated

September 8, 2021

Sponsor

Taro Iguchi, MD, PHD

Collaborators

Bayer Yakuhin, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03305224

Brief Title

The Combination Therapy With Ra-223 and Enzalutamide

Acronym

CORE-OCU

Official Title

The Study of Combination Therapy With Radium-223 and Enzalutamide in Osaka City University

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 27, 2017 (Actual)

Primary Completion Date

October 30, 2021 (Anticipated)

Study Completion Date

March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Taro Iguchi, MD, PHD

Collaborators

Bayer Yakuhin, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Castration-resistant Prostate Cancer, Bone Metastases

Keywords

castration-resistant prostate cancer, bone metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ra-223 + Enzalutamide

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Ra-223 in combination with enzalutamide

Intervention Description

Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with enzalutamide 160 mg per a day

Primary Outcome Measure Information:

Title

Changes in Alkaline phosphatase (ALP)

Description

Percentage of change from baseline to 6 months (or earlier for those who discontinue study therapy)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Tolerability of Radium-223 therapy

Description

Proportion of patients who complete 6 times injections of radium-223

Time Frame

6 months

Title

Evaluation for bone metastasis by 18F-NaF-PET

Description

Fractional decline of intensity of tracer uptake measured by SUVmax on 18F-NaF-PET at 1, 3, 6 months.

Time Frame

1, 3, 6 months

Title

Evaluation for bone metastasis by bone scintigraphy

Description

The change of Bone Scan Index (BSI) by bone scintigraphy at 1, 3, 6 months.

Time Frame

1, 3, 6 months

Title

Overall Survival Rate

Description

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 Frame

3 years

Title

Time to occurrence of Symptomatic Skeletal-related Events (SSEs)

Description

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 Frame

1 year

Title

Time to occurrence of visceral metastasis

Description

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 Frame

1 year

Title

Time to initiation of cytotoxic chemotherapy

Description

The time to initiation of cytotoxic chemotherapy is defined as the time from registration to the date of initiation of cytotoxic chemotherapy.

Time Frame

1 year

Title

Changes in Prostate Specific Antigen (PSA)

Description

Percent change in prostate-specific antigen (PSA) from baseline at 6 months.

Time Frame

6 months

Title

Changes From Baseline for Brief Pain Inventory (BPI)

Description

The change for the BPI-SF (Brief Pain Inventory-Short Form) score was calculated.

Time Frame

6 months

Title

Changes From Baseline for Functional Assessment of Cancer Therapy - Prostate (FACT-P)

Description

The change for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated.

Time Frame

6 months

Title

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Description

Number of participants with adverse events as a measure of safety and tolerability.

Time Frame

6 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients diagnosed as CRPC Surgical or those who will be treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period, Patients who had >30% of PSA response to enzalutamide prior to enrollment, Interval between PSA progression and enrollment is up to 3 months, With bone metastases (≥ 2 hot spots) on bone scintigraphy within previous 24 weeks, No intention to use anti-cancer chemotherapy within the next 6 months, Eastern Cooperative Oncology Group performance status (ECOG-PS): 0-1, Life expectancy ≥ 6 months, 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, Age ≥ 20, Ability to understand and the willingness to sign a written informed consent (IC). Exclusion Criteria: Prior chemotherapy or planned treatment with chemotherapy, PSA progression within 3 months after initiation of enzalutamide Prior treatment with corticosteroids, estramustine or abiraterone acetate, Any systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases, Had history of gastrointestinal bleeding or ulcer within 3 months prior to study entry, History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations, History of or known brain metastasis, Malignant lymphadenopathy ≧1.5 cm in short axis, Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging), Any other serious illness or medical condition Substance abuse, medical, psychological, or social conditions that might interfere with the subject's participation in the study or evaluation of the study Results Those who judged to be inappropriate by the principal investigator or co-investigator.

Facility Information:

Facility Name

Osaka City University Graduate School of Medicine

City

Osaka

ZIP/Postal Code

545-8585

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

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The Combination Therapy With Ra-223 and Enzalutamide

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