UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005432
Receipt number R000006448
Scientific Title Clinical efficacy and safety of fucoidan for biochemical recurrence after radical prostatectomy
Date of disclosure of the study information 2012/12/01
Last modified on 2015/10/21 07:06:40

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinical efficacy and safety of fucoidan for biochemical recurrence after radical prostatectomy

Acronym

Fucoidan for prostate cancer

Scientific Title

Clinical efficacy and safety of fucoidan for biochemical recurrence after radical prostatectomy

Scientific Title:Acronym

Fucoidan for prostate cancer

Region

Japan


Condition

Condition

prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy and safety of fucoidan for biochemical recurrence after radical prostatectomy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Partial regression rate accoriding to PSA level, at 6mo. after intervention

Key secondary outcomes

1) rate of improvement of PSA slope,, at 6mo. after intervention
2) alteration of testosterone level
3) safety


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

Food

Interventions/Control_1

Fucoidan (Marine Products Kimuraya Co.Ltd., Japan)

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

80 years-old >

Gender

Male

Key inclusion criteria

1) sequential 2 points of 0.2ng/ml or more of serume PSA level, after radical prostatectomy for organ-confined prostate cancer
2) obtaining of informed consent in writing

Key exclusion criteria

1) undergoing hormonal therapy
2) suspecting of distant metastasis
3) severe comorbidities
4) during 3 mo. before attempt of fucoidan intervention, receiving any types of complementary/alternative medicine
5) inappropriate, judged by doctor

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Ogawa

Organization

Kyoto University Graduate School of Medicine

Division name

Urology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3337

Email

ky7527@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Yoshimura

Organization

Kyoto University Graduate School of Medicine

Division name

Urology

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3337

Homepage URL


Email

ky7527@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Dept. of Urology, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

2012 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2012 Year 04 Month 11 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date

2016 Year 02 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

2011 Year 04 Month 13 Day

Last modified on

2015 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006448


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name