UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030633 |
|---|---|
| Receipt number | R000034978 |
| Scientific Title | Clinical significance of bone metastasis with extraosseous soft-tissue mass in prostate cancer patients |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2017/12/29 14:13:26 |
* 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
Clinical significance of bone metastasis with extraosseous soft-tissue mass in prostate cancer patients
Acronym
Clinical significance of bone metastasis with extraosseous soft-tissue mass in prostate cancer patients
Scientific Title
Clinical significance of bone metastasis with extraosseous soft-tissue mass in prostate cancer patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroki Kato |
Organization
Gifu University School of Medicine
Division name
Radiology
Zip code
Address
1-1 Yanagido, Gifu 501-1194 Japan
TEL
058-230-6439
hkato@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Kato |
Organization
Gifu University School of Medicine
Division name
Radiology
Zip code
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6439
Homepage URL
hkato@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034978
