UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015265
Receipt number R000017730
Scientific Title The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.
Date of disclosure of the study information 2014/10/01
Last modified on 2019/12/27 19:26:00

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Basic information

Public title

The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.

Acronym

The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.

Scientific Title

The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.

Scientific Title:Acronym

The Efficacy of switching from gonadotropin releasing hormone (GnRH) agonist to antagonist for the treatment of castration resistant prostate cancer (CRPC) patients.

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the transition of PSA, total prostate volume, serum testosterone, luteinizing hormone (LH), follicle- stimulating hormone (FSH), BAP, IPSS by switching from GnRH agonist to antagonist for the treatment of CRPC patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

PSA response.

Key secondary outcomes

Total prostate volume, Serum testosterone, LH, FSH, BAP, IPSS, safety (CTCAE ver. 4.0), QOL


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1.pathologically diagnosed as prostate cancer. (neuroendocrine cancer or small cell cancer were excluded.)
2.gnrH agonist resistance.
3.adminstration of gnrh agonist during the study, in case the patients have not received surgical castration.
4.serum testosterone < 0.50 ng/ml
5.serum psa > 2.5 ng/ml
6.If zoledronic acid hydrate is administered, there is no change of dose at least four weeks before dosage of degarelix.
7.psa is greater than 2.5 ng/ml within six months. the rise of psa has to be at least 50% over nadir and has to be confirmed by a second psa at least two weeks later.
8.as for the patients who had received systemic chemotherapy, patients received no more than two regimens including at least one course of docetaxel therapy.
9.performance status(ps; eastern co-operative oncology group) 0-1.(the patients whose ps are 2 due to bone pain are permitted.)
10.age more than 17
11.written informed consent was obtained.
12.the patients can prevent pregnancy by appropriate methods (a condom or a pessary) from the start of study to at least three months after the last dose.

Key exclusion criteria

1. receive radiation therapy within twelve weeks before dosage of degarelix.
2. when the investigator thinks the patient is ineligible.
3. other systemic disease which is severe or uncontrollable.
4. severe allergy to degarelix.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Sakamoto

Organization

Chiba University Hospital

Division name

Urology

Zip code


Address

1-8-1 inohana cho, Chuo-ku, Chiba-city, Chiba Prf. Japan

TEL

043-226-2134

Email

rbatbat1@chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Sakamoto

Organization

Chiba University Hospital

Division name

Urology

Zip code


Address

1-8-1 inohana cho, Chuo-ku, Chiba-city, Chiba Prf. Japan

TEL

043-226-2134

Homepage URL


Email

rbatbat1@chiba-u.jp


Sponsor or person

Institute

Department of Urology, Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical Company Limited
AstraZeneca K.K.

Organization

Division

Category of Funding Organization

Profit organization

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 01 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 09 Month 24 Day

Date of IRB

2014 Year 03 Month 06 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2019 Year 12 Month 12 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We evaluate the transition of PSA, total prostate volume, serum testosterone, luteinizing hormone (LH), follicle- stimulating hormone (FSH), BAP, IPSS by switching from GnRH agonist to antagonist for the treatment of CRPC patients.


Management information

Registered date

2014 Year 09 Month 26 Day

Last modified on

2019 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017730


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name