UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023897
Receipt No. R000027376
Scientific Title Prospective study of evaluating the efficacy and safety of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Date of disclosure of the study information 2016/09/01
Last modified on 2019/09/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study of evaluating the efficacy and safety of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Acronym Prospective study of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Scientific Title Prospective study of evaluating the efficacy and safety of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Scientific Title:Acronym Prospective study of Radium-223 dichloride in patients with castration-resistant prostate cancer and bone metastases
Region
Japan

Condition
Condition castration-resistant prostate cancer with bone metastases
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness of Radium-223 dichloride for castration-resistant prostate cancer with bone metastases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes change rate of PSA at six month after completion of Radium-223 dichloride therapy
Key secondary outcomes Rates of Adverse events, improvement rate of pain from bone metastases, bone metastases progressive free survival, distant metastases free survival excluding bone metastases, pattern of progression, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Radium-223 dichloride (55 kBq/kg) on day 1 every 4 weeks
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
90 years-old >=
Gender Male
Key inclusion criteria 1) Confirmation of castration-resistant prostate cancer and bone metastases
2) Age from 20 to 80 years old
3) Preserved hematologic function within 28 days as follows;
i) neutrophile count >=1,500/mm3
ii) hemoglobin >= 10.0 g/dL
iii) platelet count >=100,000/mm3
4) Written informed consent is taken.
Key exclusion criteria 1) organ metastases excluding bone metastases
2) active concomitant malignancy
3) inflammatory bowel disease (Crohn's disease or ulcerative colitis)
4) use of chemotherapy with myelosuppresion reaction at the same time
5) difficult to participate with the trial, having mentel disorder or psychiatric symptoms
6) immuno-suppression treatment
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Momma
Organization National Hospital Organization Saitama Hospital
Division name Urology
Zip code 351-0102
Address 2-1, Suwa, Wako-shi, Saitama, 351-0102, JAPAN
TEL 048-462-1101
Email monma-jua@umin.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Momma
Organization National Hospital Organization Saitama Hospital
Division name Urology
Zip code 351-0102
Address 2-1, Suwa, Wako-shi, Saitama, 351-0102, JAPAN
TEL 048-462-1101
Homepage URL
Email monma-jua@umin.ac.jp

Sponsor
Institute National Hospital Organization Saitama Hospital
Institute
Department

Funding Source
Organization National Hospital Organization Saitama Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee, National Hospital Organization Saitama Hospital
Address 2-1, Suwa, Wako-shi, Saitama, 351-0102, JAPAN
Tel 048-462-1101
Email hiizuka@wakho.hosp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2016 Year 08 Month 01 Day
Date of IRB
2016 Year 09 Month 01 Day
Anticipated trial start date
2016 Year 09 Month 02 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 01 Day
Last modified on
2019 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.