UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical significance of bone metastasis with extraosseous soft-tissue mass in prostate cancer patients
Title of the study (Brief title)	Clinical significance of bone metastasis with extraosseous soft-tissue mass in prostate cancer patients
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the differences in the clinical features of prostate cancer (PC) bone metastases (PCBMs) with and without extraosseous soft-tissue masses (ESTMs).
Basic objectives2	Others
Basic objectives -Others	Clinical features of PCBMs with and without ESTMs were compared.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	age, T/N stage, organ metastases, Gleason sum score, initial clinical symptoms, treatment methods, sites of PCBMs, initial PSA level (ng/mL), PSA nadir (ng/mL), PSA reduction rate (%), time from the initiation of therapy to PSA nadir (day), PSA doubling time (day), PSA progression-free survival (day), and overall survival (day)
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	55 years-old <=
Age-upper limit	92 years-old >=
Gender	Male
Key inclusion criteria	Patients with histopathologically or clinically diagnosed PC
Key exclusion criteria	Patients without bone metastasis
Target sample size	720

Research contact person
Name of lead principal investigator	Hiroki Kato
Organization	Gifu University School of Medicine
Division name	Radiology
Address	1-1 Yanagido, Gifu 501-1194 Japan
TEL	058-230-6439
Email	hkato@gifu-u.ac.jp

Public contact
Name of contact person	Hiroki Kato
Organization	Gifu University School of Medicine
Division name	Radiology
Address	1-1 Yanagido, Gifu 501-1194, Japan
TEL	058-230-6439
Homepage URL
Email	hkato@gifu-u.ac.jp

Sponsor
Institute	Gifu University
Institute
Department

Funding Source
Organization	Gifu University
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	2018 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 08 Day
Anticipated trial start date	2017 Year 10 Month 08 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	None

Management information
Registered date	2017 Year 12 Month 29 Day
Last modified on	2017 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034978