UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015331
Receipt number R000017826
Scientific Title A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer
Date of disclosure of the study information 2014/10/02
Last modified on 2020/10/07 21:34:05

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Basic information

Public title

A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer

Acronym

A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer

Scientific Title

A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer

Scientific Title:Acronym

A study of safety and efficacy of three-dimensional prostate biopsy method for patients with suspected prostate cancer

Region

Japan


Condition

Condition

suspected prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the safety and efficacy of three-dimensional prostate biopsy method

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cancer detection rate
rate of occurrence of a complication

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

three-dimensional prostate biopsy

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

1.patients with susupected prostate cancer who had previously experience of prostate biopsies
2.patients who satisfied all of criteria as follows
a)patients suspected prostate cancer at apex or ventral portion by MRI
b)patients who have prostate volume more than 30ml
c)patients who have prostate volume less than 30ml and have middle lobe enlargement

Key exclusion criteria

1.patients who cannot undergo lumbar spinal anesthesia
2.patients who decide not to join this study

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeo Kosaka

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

takemduro@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Kobayashi

Organization

Keio University School of Medicine

Division name

Department of Urology

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL


Email

shadow87jp@yahoo.co.jp


Sponsor or person

Institute

Department of Urology, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology, Keio University School of Medicine

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

2014 Year 10 Month 02 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

Completed

Date of protocol fixation

2014 Year 10 Month 02 Day

Date of IRB

2014 Year 09 Month 30 Day

Anticipated trial start date

2014 Year 10 Month 02 Day

Last follow-up date

2018 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2018 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 02 Day

Last modified on

2020 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017826


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name