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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029422
Receipt No. 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 2019/04/08

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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
Email 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
Email taro@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
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 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 04 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032035

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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