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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015519
Receipt No. 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

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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
Last 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
1st 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
Institute Jikei University School of Medicine
Institute
Department

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
URL(English) https://upload.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


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