UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002792
Receipt number R000003365
Scientific Title Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
Date of disclosure of the study information 2009/11/26
Last modified on 2009/11/20 14:00:44

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Basic information

Public title

Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.

Acronym

Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.

Scientific Title

Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.

Scientific Title:Acronym

Multicenter comparative study to examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.

Region

Japan


Condition

Condition

Prostate cancer with bone metastasis

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of zoledronic acid in prostate cancer with bone metastasis at different hormone sensitivity status.
To examine bone marker (serum NTx) to assess judgment of the efficacy at early treatment and prognosis forecast.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change of bone metastasis EOD grade

Key secondary outcomes

Change of SRE and BPI


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hormon sensitive during zoledronic acid therapy

Interventions/Control_2

Hormon refractory after zoledronic acid therapy

Interventions/Control_3

Hormon refractory before zoledronic acid therapy

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

Patients of prostate cancer with bone metastasis

Key exclusion criteria

1.History of hypersensitivity for zoledronic acid or other bisphosphonate
2.Renal dysfunction(serum creatinine more than 3.0mg/dL)
3.Active concomititant malignancy
4.Severe coexisting disease
5.Invasive dental treatment within 3 months
6.Other bisphosphonate therapy for injection within 6 months
7.Not suitable for this trial

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Higashihara

Organization

Kyorin University

Division name

Department of urology

Zip code


Address

6-20-2 Shinkawa,Mitaka-city, Tokyo

TEL

0422-47-5511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takatsugu Okegawa

Organization

Kyorin University

Division name

Department of urology

Zip code


Address

6-20-2 Shinkawa,Mitaka-city,Tokyo

TEL

0422-47-5511

Homepage URL


Email



Sponsor or person

Institute

Tama Prostate cancer Bone metastasis Study group

Institute

Department

Personal name



Funding Source

Organization

None

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


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

杏林大学医学部付属病院(東京都)、青梅市立病院(東京都)、河北総合病院(東京都)、公立阿伎留医療センター(東京都)、国立病院機構災害医療センター(東京都)、佐々総合病院(東京都)、多摩北部医療センター(東京都)、東京医科大学八王子医療センター(東京都)、都立府中病院(東京都)、西東京中央総合病院(東京都)、一橋病院(東京都)


Other administrative information

Date of disclosure of the study information

2009 Year 11 Month 26 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

2007 Year 04 Month 18 Day

Date of IRB


Anticipated trial start date

2007 Year 04 Month 01 Day

Last follow-up date

2016 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 11 Month 23 Day

Last modified on

2009 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003365


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name