UMIN-CTR Clinical Trial

Basic information
Public title	Study on evaluation of treatment and prognosis using Bon Scan Index (BSI) in the bone scintigraphy at the prostate cancer bone metastases evaluation
Acronym	The evaluation of bone metastases using BSI in the bone scintigraphy
Scientific Title	Study on evaluation of treatment and prognosis using Bon Scan Index (BSI) in the bone scintigraphy at the prostate cancer bone metastases evaluation
Scientific Title:Acronym	The evaluation of bone metastases using BSI in the bone scintigraphy
Region	Japan

Condition
Condition	Prostate cancer with bone metastasis
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Quantification of the result in the bone scintigraphy using the BSI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The correlation between rate of change PSA and the bone turnover markers and rate of change of the BSI by the treatment
Key secondary outcomes	The correlation between progression-free survival and overall survival and rate of change of the BSI by the treatment

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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Prostate cancer with bone metastasis before hormonal therapy or Recurred prostate cancer with bone metastasis before docetaxel treatment
Key exclusion criteria	prostate cancer without bone metastasis
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Mizokami
Organization	Kanazawa University Hospital
Division name	Department of Urology
Zip code	920-8641
Address	13-1 takaramachi, Kanazawa
TEL	076-265-2393
Email	mizokami@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Mizokami
Organization	Kanazawa University Hospital
Division name	Department of Urology
Zip code	920-8641
Address	13-1 takaramachi, Kanazawa
TEL	076-265-2393
Homepage URL
Email	mizokami@staff.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Fuji Film RI Pharma
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	Kanazawa Univerisity
Address	13-1 Takaramachi, Kanazawa, Ishikawa
Tel	076-265-2000
Email	mizokami@staff.kanazawa-u.ac.jp

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	2012 Year 05 Month 01 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/29633398
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	247
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Now we are submitting the result and waiting for the accept.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	There was not adverse effects because of observational study.
Outcome measures	The primary end-points are post-treatment changes in BSI compared with baseline and event-free and PSA progression- free survival. Secondary end-points include changes in BSI determined by an ANN, other parameters of PSA, bone meta- bolic markers and overall survival from baseline until the end of post-treatment follow up for 3 years.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 04 Month 01 Day
Date of IRB	2012 Year 02 Month 15 Day
Anticipated trial start date	2012 Year 04 Month 15 Day
Last follow-up date	2017 Year 03 Month 01 Day
Date of closure to data entry	2017 Year 03 Month 01 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information	Investigate the correlation between BSI using bonenavi in bone scintigraphy and PSA and bone turnover marker.

Management information
Registered date	2012 Year 04 Month 28 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009260