UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study on clinical efficacy of Zofigo on castration resistant prostate cancer with bone metastasis
Title of the study (Brief title)	Effect of Zofigo on castration resistant prostate cancer
Region	Japan

Condition
Condition	prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study the effect of Zofigo on castrationprostate cancer with bone metastasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change rates of alkaline phosphatase levelsat 12 weeks after the initiation treatment
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	castration resistant prostate cancer bone metastasis match to criteria for zofigo treatment obtain written informed consent
Key exclusion criteria	inflammatory bowel disease spinal cord compression due to bone metastasis without optimal treatment unfixed fracture other reasons considered for unfit to Zofigo treatment
Target sample size	50

Research contact person
Name of lead principal investigator	Kazuhiro Suzuki
Organization	Gunma University Graduate School of Medicine
Division name	Department of Urology
Address	3-39-22 Showa-machi, Maebashi, Gunma Japan
TEL	027-220-8300
Email	kazu@gunma-u.ac.jp

Public contact
Name of contact person	Yoshiyuki Miyazawa
Organization	Gunma University Graduate School of Medicine
Division name	Department of Urology
Address	3-39-22 Showa-machi, Maebashi, Gunma Japan
TEL	027-220-8303
Homepage URL
Email	miya.yoshi@hotmail.com

Sponsor
Institute	Department of Urology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Urology, Gunma University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 07 Day
Anticipated trial start date	2016 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Evaluation will be performed at pre treatment, every 4 week during treatment.

Management information
Registered date	2016 Year 09 Month 14 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027701