UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the clinical meaning of the fever after zoledronic acid administration for therapy of bone metastasis arising from prostate cancer
Title of the study (Brief title)	Inspection of the fever after zoledronic acid administration for therapy of bone metastasis from prostate cancer
Region	Japan

Condition
Condition	Hormone therapy naive prostate cancer patient with bone metastasis
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We examine the clinical meaning of the fever after zoledronic acid administration combination with the primary hormone therapy for the prostate cancer patients with bone metastasis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PSA normalization rate (less than 4ng/ml) as of three months after start of the treatment
Key secondary outcomes

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	Combination of CAB therapy and zoledronic acid administration
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. Patient with prostate cancer defined by pathological examination 2. Patient with bone metastasis diagnosised by bone scan 3.Hormone therapy untreated patient
Key exclusion criteria	1. Patient received hormoe therapy previously 2. Patient plans the radiation therapy to the prostate with hormone therapy 3. Patient administered NSAIDs or corticosteroid 4. Patient with a severe renal function disorder 5. Patient that is continuing dental treatment such as the tooth extraction 6. Patient with severe psychosis 7. Patient with double cancer
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshiyuki Miyaji
Organization	Kawasaki Medical School
Division name	Department of urology
Address	577 Matsushima, Kurashiki, Japan
TEL	086-462-1111
Email	miyaji@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Yoshiyuki Miyaji
Organization	Kawasaki Medical School
Division name	Department of urology
Address	577 Matsushima, Kurashiki, Japan
TEL	086-462-1111
Homepage URL
Email	miyaji@med.kawasaki-m.ac.jp

Sponsor
Institute	Chugoku Shikoku Genitourinary Cancer Study Group
Institute
Department

Funding Source
Organization	Chugoku Shikoku Genitourinary Cancer Study Group
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	川崎医科大学附属病院（岡山県）、川崎医科大学附属川崎病院（岡山県）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 10 Day
Anticipated trial start date	2014 Year 04 Month 23 Day
Last follow-up date	2017 Year 09 Month 30 Day
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

Management information
Registered date	2014 Year 02 Month 26 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015001