UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Kenta Miki
Organization	Jikei University School of Medicine
Division name	Department of Urology
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	Kenta Miki
Organization	Jikei University School of Medicine
Division name	Department of Urology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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