UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015519
Receipt number R000018030
Scientific Title A comparative study on the efficacies of gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist in neoadjuvant androgen deprivation therapy combined with transperineal prostate brachytherapy for localized prostate cancer
Date of disclosure of the study information 2014/11/04
Last modified on 2019/02/12 11:42:06

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Basic information

Public title

A comparative study on the efficacies of gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist in neoadjuvant androgen deprivation therapy combined with transperineal prostate brachytherapy for localized prostate cancer

Acronym

A comparative study on the efficacies of gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist in neoadjuvant androgen deprivation therapy combined with transperineal prostate brachytherapy for localized prostate cancer

Scientific Title

A comparative study on the efficacies of gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist in neoadjuvant androgen deprivation therapy combined with transperineal prostate brachytherapy for localized prostate cancer

Scientific Title:Acronym

A comparative study on the efficacies of gonadotropin-releasing hormone (GnRH) agonist and GnRH antagonist in neoadjuvant androgen deprivation therapy combined with transperineal prostate brachytherapy for localized prostate cancer

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy between GnRH antagonist, degarelix, and GnRH agonists on the recovery of serum testosterone levels and reduction in total prostate volume (TPV) in neoadjuvant androgen deprivation therapy (ADT) for patient with PCa undergoing 125I-transperineal prostate brachytherapy (TPPB).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Normalization of serum testosterone levels (>50 ng/dL) after neoadjuvant ADT

Key secondary outcomes

1) The percent reduction in TPV during neoadjuvant ADT
2) The percent increase of TPV after 125I-TPPB
3) The improvement of QOL using the IPSS for lower urinary tract symptoms
4) The proportion of patients who have serum testosterone levels over 50 ng/dL at 12 weeks after 125I-TPPB
5) The improvement of QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The initial dose of degarelix is 240 mg given as 2 subcutaneous injections of 120 mg in the abdomen. After the initial dose, the maintenance dose of 80 mg is given as one subcutaneous injection in the abdomen every 4 weeks.

Interventions/Control_2

Leuprorelin acetate is administered subcutaneously once every 4 weeks at a dose of 3.75 mg, or goserelin acetate is administered subcutaneously in the abdomen once every 4 weeks at a dose of 3.6 mg.

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) Be a definitive histological diagnosis of PCa by needle biopsy
2) Be adaptable to 125I-TPPB and requred for neoadjuvant ADT
3) Have low/intermediate-risk localized PCa as follows.
Low-risk PCa: cT1a-T2a, Gleason score: 2-6 and PSA<10 ng/ml
Intermediate-risk PCa: cT2b -T2c or Gleason score: 7, or PSA 10-20 ng/ml
(exept for Gleason score>=8, PSA>=20 ng/ml)
4) TPV: 35-60 ml
5) Recieved written informed consent prior to initiating this clinical study

Key exclusion criteria

1) Have previously received hormonal therapies including GnRH agonists, GnRH antagonists, and antiandrogen agents, estorogen agents or orchiectomy for PCa
2) Be using 5alpha reductase inhibitor
3) Have severe asthma (e.g. use inhaled corticosteroid that is necessary for daily life), anaphylactic reaction, severe urticaria and complication or medical history of angioedema
4) Be sensitive to mannitol
5) Have multiple malignancies
6) Have ALT>= 100 IU/L or total bilirubin >= 1.3 mg/dL
7) Be considered as inappropriate by the investigator

Target sample size

56


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenta Miki

Organization

Jikei University School of Medicine

Division name

Department of Urology

Zip code


Address

3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Japan

TEL

03-3433-1111

Email

kentamiki@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenta Miki

Organization

Jikei University School of Medicine

Division name

Department of Urology

Zip code


Address

3-25-8 Nishi-Shimbashi, Minato-ku, 105-8461, Japan

TEL

03-3433-1111

Homepage URL


Email

kentamiki@jikei.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Translational Research Informatics Center (Foundation for Biomedical Research and Innovation)


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 11 Month 04 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 06 Month 02 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 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

2014 Year 10 Month 24 Day

Last modified on

2019 Year 02 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name