The Combination Therapy With Ra-223 and Enzalutamide

Bone Metastases Clinical Trial

— CORE-OCU  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03305224
• Other study ID #: CORE-OCU
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 27, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: September 2021
• Source: Osaka City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 31, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Metastases
• Castration-resistant Prostate Cancer
• Neoplasm Metastasis
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Osaka City University Graduate School of Medicine	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Taro Iguchi, MD, PHD	Bayer Yakuhin, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Alkaline phosphatase (ALP)	Percentage of change from baseline to 6 months (or earlier for those who discontinue study therapy)	6 months
Secondary	Tolerability of Radium-223 therapy	Proportion of patients who complete 6 times injections of radium-223	6 months
Secondary	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.	1, 3, 6 months
Secondary	Evaluation for bone metastasis by bone scintigraphy	The change of Bone Scan Index (BSI) by bone scintigraphy at 1, 3, 6 months.	1, 3, 6 months
Secondary	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.	3 years
Secondary	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).	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	Changes in Prostate Specific Antigen (PSA)	Percent change in prostate-specific antigen (PSA) from baseline at 6 months.	6 months
Secondary	Changes From Baseline for Brief Pain Inventory (BPI)	The change for the BPI-SF (Brief Pain Inventory-Short Form) score was calculated.	6 months
Secondary	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.	6 months
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Number of participants with adverse events as a measure of safety and tolerability.	6 months