UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033343
Receipt number R000038013
Scientific Title A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer
Date of disclosure of the study information 2018/07/10
Last modified on 2020/08/05 11:30:41

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Basic information

Public title

A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer

Acronym

A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer

Scientific Title

A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer

Scientific Title:Acronym

A prospective observational study of comparison between radical prostatectomy and radiation therapy for high risk prostate cancer

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Endocrinology and Metabolism Endocrine surgery Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In order to prevent death of prostate cancer, we aim to detect prostate cancer as early as possible and aim at it.

Basic objectives2

Others

Basic objectives -Others

By clarifying the characteristics of treatment, we aim to construct a system that can provide optimal treatment to patients.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Blood / urinalysis, physical findings, tumor assessment of prostate and pelvic lymph nodes (non-contrast MRI) are performed every 3 months.

Key secondary outcomes

Evaluation of complications (international prostate symptom score IPSS (6)), quality of life after surgery (EuroQol 5 Dimension; EQ - 5D (7) and FACT - P (8)) and erectile function (International erectile function score; Evaluation of IIEF 5 (9)) every 3 months.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Patients suspected of having prostate cancer due to PSA at the first visit. Patients diagnosed with high-risk prostate cancer who have no distant metastases. Patients over the age of 20 at the time of obtaining consent. Patients who can obtain written informed consent.

Key exclusion criteria

Patients who were not tested for high-risk prostate cancer or were found to have metastatic prostate cancer as a result of further testing (however, data and samples up to that point are used for preliminary analysis).

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koshiro Nishimoto

Organization

Saitama Medical University International Medical Center

Division name

UroOncology

Zip code


Address

1397-1 Yamane, Hidaka, Saitama 350-1241, Japan

TEL

+81-42-984-4111

Email

k.nishimoto@keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koshiro Nishimoto

Organization

Saitama Medical University International Medical Center

Division name

UroOncology

Zip code


Address

1397-1 Yamane, Hidaka, Saitama 350-1241, Japan

TEL

+81-42-984-4111

Homepage URL

http://www.international.saitama-med.ac.jp/chiken/results.php

Email

k.nishimoto@keio.jp


Sponsor or person

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

埼玉医科大学国際医療センター


Other administrative information

Date of disclosure of the study information

2018 Year 07 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

2018 Year 04 Month 20 Day

Date of IRB

2018 Year 05 Month 02 Day

Anticipated trial start date

2018 Year 05 Month 02 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry

2031 Year 03 Month 31 Day

Date trial data considered complete

2031 Year 03 Month 31 Day

Date analysis concluded

2031 Year 03 Month 31 Day


Other

Other related information

None


Management information

Registered date

2018 Year 07 Month 10 Day

Last modified on

2020 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038013


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name