UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018268 |
|---|---|
| Receipt number | R000021144 |
| Scientific Title | Clinical investigation of change of bone-related marker between denosumab and zoledronic acid in patients with treatment-naive,bone-metastasis prostate cancer:prospective, multiinstitutional,cohort study |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2015/12/09 20:18:51 |
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Basic information
Public title
Clinical investigation of change of bone-related marker between denosumab and zoledronic acid in patients with treatment-naive,bone-metastasis prostate cancer:prospective, multiinstitutional,cohort study
Acronym
Comparative study between denosumab and zoledronic acid in terms of bone marker
Scientific Title
Clinical investigation of change of bone-related marker between denosumab and zoledronic acid in patients with treatment-naive,bone-metastasis prostate cancer:prospective, multiinstitutional,cohort study
Scientific Title:Acronym
Comparative study between denosumab and zoledronic acid in terms of bone marker
Region
| Japan |
Condition
Condition
treatment-naive prostate cancer with bone metastasis
Classification by specialty
| Hematology and clinical oncology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compare denosumab with zoledronic acid in terms of change of bone markers in patients with treatment-naive,bone-metastasis prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
change of bone marker
Key secondary outcomes
adverse events, skeletal related event-free survival, PSA progression-free survival,change of renal function
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
treatment naive prostate cancer with bone metastasis, recurrent prostate cancer due to bone metastasis,performance status under 2
Key exclusion criteria
history of radiation therapy to bone metastasis, history of dental treatment within 6 weeks of entry,Grade 4 renal insuffuciency such as eGFR under 30 or serum creatinine over 3
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun-ichi Hori |
Organization
Asahikawa Medical University
Division name
Renal and Urologic Surgery
Zip code
Address
Midorigaoka Higashi 2-1-1-1, Asahikawacity, Hokkaido
TEL
0166-68-2533
urohori@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun-ichi Hori |
Organization
Asahikawa Medical University
Division name
Renal and Urologic Surgery
Zip code
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa city, Hokkaido
TEL
0166-68-2533
Homepage URL
urohori@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Renal and Urologic Surgery, Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Renal and Urologic Surgery, Asahikawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukagawa city hospital, Furano kyoukai Hospital, Kitami red cross hospital, Megumino hospital, Kitasaito hospital,JR Sapporo Hospital
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
| 2015 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-institutional, prospective, cohort study
We`ll observe 50 patients between December 1st 2015 to November 30th 2018 who go to our institution and related ones according to our already decided ctireria.
We`ll regulary investigate laboratry datas including bone-related markers at 3 months interval as well as CT, bone scintigraphy and bone mineral density at 6 months interval for 2 years.
Management information
Registered date
| 2015 | Year | 07 | Month | 10 | Day |
Last modified on
| 2015 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021144
