The study of COmbination therapy with Radium-223 and Enzalutamide in Osaka City University - CORE-OC

Kato Minoru0 sites10 target enrollmentMarch 13, 2019

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Kato Minoru
Enrollment: 10
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

We could not evaluate the efficacy of Ra-223 for patients with metastatic castration-resistant prostate cancer that showed only PSA progression after enzalutamide treatment due to the small number of patients. However, There were no novel adverse events(AEs)or increase of the frequency of AEs in patients treated with combination of enzalutamide and Ra-223 compared with Ra223 monotherapy. This indicate that the combination of enzalutamide and Ra-223 could be tolerable for patients with mCRPC.

Registry

who.int

Start Date

March 13, 2019

End Date

April 28, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Kato Minoru

Eligibility 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 6 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:

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),