UMIN-CTR Clinical Trial

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011648
Receipt number R000013619
Scientific Title Evaluation of therapeutic effect on prostate cancer patients with bone metastases using Bone Scan Index (BSI)
Date of disclosure of the study information 2013/09/04
Last modified on 2013/09/04

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Basic information

Public title

Evaluation of therapeutic effect on prostate cancer patients with bone metastases using Bone Scan Index (BSI)

Acronym

Evaluation of therapeutic effect of prostate cancer by BSI

Scientific Title

Evaluation of therapeutic effect on prostate cancer patients with bone metastases using Bone Scan Index (BSI)

Scientific Title:Acronym

Evaluation of therapeutic effect of prostate cancer by BSI

Region

Japan


Condition

Condition

Prostate cancer patients with bone metastasis

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate and quantify the therapeutic effect by BSI in bone scintigraphy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The change rate of BSI before and after treatment

Key secondary outcomes

The correlation between change rate of BSI and SRE event rate
The correlation between change rate of BSI and PSA, bone turnover markers

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.


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


In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.


Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1.Male patients who were histologically diagnosed as prostate cancer
2.Patients who underwent 99mTc-MDP bone scintigraphy and have more than one bone metastasis
3.Patients who expects more than 6 months life
4. Patients older than 20 years
5.Patients who offered written informed consent

Key exclusion criteria

1. Patients with difficulty in bone scintigraphy data analsysis due to the structural deformity or extraosseous uptake in bone scintigraphy
2. Patients corresponding to contraindication of Tc 99m methylene diphosphonate
3.Patient who were inappropriate for this study judged by medical doctor

Target sample size

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio Nonomura

Organization

Osaka University Graduate School of Medicine

Division name

Department of Organ Specific Regulation (Urology)

Zip code


Address

2-2 yamada-oka, Suita, Osaka

TEL

81668793531

Email

nono@uro.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motohide Uemura

Organization

Osaka University Graduate School of Medicine

Division name

Department of Organ Specific Regulation (Urology)

Zip code


Address

2-2 yamada-oka, Suita, Osaka

TEL

81668793531

Homepage URL


Email

uemura@uro.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name


Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.


Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2013 Year 09 Month 04 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

2013 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 17 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To investigate the change rate of BSI before and 6 months after treatment prospectively.
And the correlation between BSI and PSA or bone turnover markers also investigate.


Management information

Registered date

2013 Year 09 Month 04 Day

Last modified on

2013 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013619