UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011442
Receipt number R000013397
Scientific Title Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.
Date of disclosure of the study information 2013/08/10
Last modified on 2013/08/10 11:14:37

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Basic information

Public title

Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.

Acronym

Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.

Scientific Title

Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.

Scientific Title:Acronym

Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.

Region

Japan


Condition

Condition

Prostate Cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Observation of skeletal related events incidence and serach for risk factors of SREs in prostate cancer patients with bone metastases treated with zoledronic acid.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skeletal related events incidence

Key secondary outcomes

Search for risk factors of SREs
(bone turnover markers, patient characteristics, PSA, bone pain, etc.)
Adverse events


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

prostate cancer patients with bone metastases are treated with zoledronic acid.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1)Patients with Histologically confirmed prostate cancer.
2) Patients with radiologic evidence of bone metastasis.
3) Patients with a life expectancy &#8805; 6 months.
4) Patient older than 20 years old.
5) Patients who give a written informed consent obtained.

Key exclusion criteria

1)Patients who have contraindications to zoledronic acid.
2)Patients without improvement of surgical wounds after invasive dental treatment.
3)Patients who have previously received zoledronic acid or denosumab.
4)Serum creatinine: more than 3.0mg/dL
5) Patient judged inappropriate for this study by the physicians

Target sample size

200


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


Email



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


TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka University Graduate School of Medicine,Department of Organ Specific Regulation (Urology)

Institute

Department

Personal name



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 08 Month 10 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 05 Month 29 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 13 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 08 Month 10 Day

Last modified on

2013 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013397


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name