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
|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)|
|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 31, 2019|
|Estimated Study Completion Date :||June 30, 2021|
|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
- 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)
- 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.
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
|Contact: Taro Iguchi, MD, PhDfirstname.lastname@example.org|
|Osaka City University Graduate School of Medicine||Recruiting|
|Osaka, Japan, 545-8585|
|Contact: Taro Iguchi, MD, PhD|