UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029422 |
|---|---|
| Receipt number | R000032035 |
| Scientific Title | The study of combination therapy with radium-223 and enzalutamide in Osaka City University |
| Date of disclosure of the study information | 2017/10/04 |
| Last modified on | 2026/07/27 23:54:24 |
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Basic information
Public title
The study of combination therapy with radium-223 and enzalutamide in Osaka City University
Acronym
CORE-OCU study
Scientific Title
The study of combination therapy with radium-223 and enzalutamide in Osaka City University
Scientific Title:Acronym
CORE-OCU study
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer with bone metastases
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate preliminary efficacy of Ra-223 in combination with Enzalutamide in progressive CRPC patients with bone metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALP change from baseline
Key secondary outcomes
1. Proportion of patients who complete 6 times injections
2. The evaluation of bone metastases by bone scintigraphy and 18F-NaF PET
3. Overall survival
4. SSE-FS: symptomatic skeletal event-free survival
5. Time to initiation of chemotherapy
6. Time to visceral metastasis
7. PSA change from baseline
8. PRO (FACT-P, BPI)
9. Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with enzalutamide.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) The patients diagnosed as CRPC: Medical or surgical castration with testosterone less than 50 ng/dL (1.7 nmol/L)
2) Those who will be performed surgical castration or treated with luteinizing hormone-releasing hormone (LHRH) agonists throughout the study period
3) PSA decline from baseline by enzalutamide >=30%
4) PSA progression after enzalutamide with 2 consecutive rises over a previous reference value (>=25% rise from nadir and >= 2 ng/mL) within 3 months prior to enrollment
5) With bone metastases (>=2 hot spots) on bone scintigraphy within previous 24 weeks
6) No intention to use anticancer-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
Absolute neutrophil count (ANC) >=1.5 x 109/L
Platelet count >=100 x 109/LTotal bilirubin level =<1.5 institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =<2.5 ULN
Creatinine =<1.5 ULN
Estimated glomerular filtration rate (GFR) >=30 mL/min/1.73 m2
10) Age >=20
11) Written informed consent
Key exclusion criteria
1) Prior chemotherapy or planned treatment with chemotherapy
2) Prior PSA primary resistance to enzalutamide within previous 3 months
3) Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bone metastases within previous 24 weeks
4) Prior treatment with radium-223
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 exceeding 1.5 cm in short-axis diameter
9) Imminent or established spinal cord compression based on clinical findings and/or MRI (Magnetic Resonance Imaging)
10) Any serious complication for using rad-223
11) Any other serious illness or medical, psychological or social condition may 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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Iguchi |
Organization
Osaka City University Graduate School of Medicine
Division name
Urology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno, Osaka 545-8585, Japan
TEL
06-6645-2121
taro@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Iguchi |
Organization
Osaka City University Graduate School of Medicine
Division name
Urology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno, Osaka 545-8585, Japan
TEL
06-6645-2121
Homepage URL
taro@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Hospital Certified Review Board
Address
1-2-7-601, Asahimachi, Abeno-ku, Osaka, Japan
Tel
06-6645-3456
ethics@med.osaka-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT03305224
Org. issuing International ID_1
National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
https://clinicaltrials.gov/study/NCT03305224
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032035
Number of participants that the trial has enrolled
10
Results
Ten patients were enrolled; 8 (80%) completed all six Ra-223 injections. Mean ALP change at approximately 6 months was -6.4% (95% CI, -17.5% to 6.2%; p=0.256). Among 8 patients with paired measurements, median PSA change was +152.4% (IQR, +39.4% to +284.5%; p=0.0078). No grade 3 or higher treatment-emergent adverse events or clinical fractures occurred.
Results date posted
| 2026 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All 10 participants were men. The median age was 78 years (range, 66-89). ECOG performance status was 0 in 4 patients (40%) and 1 in 6 patients (60%). Four patients (40%) had symptomatic bone metastases. At Ra-223 initiation, the median PSA level was 3.30 ng/mL (range, 2.44-14.26) and the median ALP level was 63 U/L (range, 41-97).
Participant flow
Ten patients were enrolled, received at least one Ra-223 injection while continuing ENZA, and were included in the analysis set. Eight patients (80%) completed all six planned Ra-223 injections. Two discontinued Ra-223 early: one because of declining activities of daily living in the context of advanced age and at the patient's request, and one because of rapid PSA progression during treatment. Neither discontinuation was attributed to a treatment-emergent adverse event. Eight patients with paired measurements at approximately 6 months were included in the ALP and PSA analyses. All 10 patients were included in the safety analysis.
Adverse events
Treatment-emergent adverse events occurred in 6 patients (60%) and were predominantly grade 1 or 2. Events included fatigue in 3 patients (30%), nausea in 2 (20%), anemia in 2 (20%), arthralgia in 2 (20%), headache in 1 (10%), back pain in 1 (10%), and a fall in 1 (10%). No grade 3 or higher treatment-emergent adverse events occurred. No clinical fractures were observed, and the absence of fracture was additionally confirmed on final computed tomography imaging. No patient discontinued Ra-223 because of an adverse event.
Outcome measures
The mean percent change in serum ALP from baseline was +4.9% at 1 month (95% CI, 0.0% to +10.0%; n=10; p=0.050), -1.5% at 3 months (95% CI, -7.7% to +5.0%; n=9; p=0.597), and -6.4% at approximately 6 months (95% CI, -17.5% to +6.2%; n=8; p=0.256). Eight of 10 patients (80%) completed all six Ra-223 injections. Conventional bone scintigraphy showed stable disease in 7 patients (70%) and progression in 3 (30%) according to PCWG3 criteria. Because of equipment failure, 18F-NaF PET was performed in only 2 patients and provided insufficient data for analysis. Median PSA change at approximately 6 months was +152.4% (IQR, +39.4% to +284.5%; n=8; p=0.0078). Median FACT-P total scores were 120.0 at screening and 119.6 at visit 3; the median change from baseline to the last on-treatment assessment was -3.8 (IQR, -9.8 to 1.0; n=10). Median BPI-SF pain-severity scores were 0.0 at screening, 1.3 at visit 3, and 0.7 at visit 6. No interpretable estimates were generated for overall survival, symptomatic skeletal event-free survival, time to chemotherapy initiation, or time to visceral metastasis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2026 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032035
