UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix
Title of the study (Brief title)	Deferred combined androgen blockade therapy using antiandrogen in metastatic prostate cancer patients treated with GnRH antagonist, degarelix
Region	Japan

Condition
Condition	Metastatic prostate cancer (Untreated)
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of add-on therapy of antiandrogen (bicalutamide and flutamide) in patients with PSA failure metastatic prostate cancer who undergo degarelix monotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Biochemical recurrence is defined as a >=25% or >= 2ng/mL increase from minimum value in PSA which is lowered by degarelix monotherapy. After antiandrogen is initiated, the efficacy of those is considered.
Key secondary outcomes	Firstly bicalutamide will be administrated, then, in case of no efficacy or biochemical recurrence, flutamide will be administrated and efficacy of this therapy will be reevaluated. If flutamide shows no efficacy, this research will be discontinued.

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	Medicine
Interventions/Control_1	Degarelix monotherapy. Bicalutamide will be added in case of recurrence. Bicalutamide will be replaced with Flutamide in case of second recurrence.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1)Patients that histologically proven prostate can. 2)Patients that treatment of the prostate cancer haven't got before. 3)Patients that has metastasis(in the TNM classification N1 and M1). 4)Patients that duration of survival is anticipated more than six months. 5)Patients that an agreement of the participation in this study is provided in a document
Key exclusion criteria	1)Patients that correspond to the taboo of the use drug. 2)Patients that had orchidectomy before. 3)Patients younger than 20 years. 4)Active multiple cancer(synchronous multiple cancer/multifocal cancer and metachronous multiple cancer/multifocal cancer with disease free survival is within 5 years except for carcinoma in situ considered as healed or lesion equal to mucosal carcinoma) 5)Active infection requiring systemic therapy 6)Body temperature >=38 degrees Celsius at registration 7)Concomitant psychiatric disease or symptom 8)Continuous systemic steroids or immunosuppressive medication(oral or intravenous) 9)Considered as inadequate by the investigator.
Target sample size	70

Research contact person
Name of lead principal investigator	Masafumi Oyama
Organization	Saitama Medical University International Medical Center
Division name	Urooncology
Address	1397-1, Yamane, Hidaka, Saitama
TEL	042-984-4111
Email	oyama@saitama-med.ac.jp

Public contact
Name of contact person	Masayuki Ishii
Organization	Saitama Medical University International Medical Center
Division name	Clinical Research Support Center
Address	1397-1, Yamane, Hidaka, Saitama
TEL	042-984-4111
Homepage URL
Email	chikens@saitama-med.ac.jp

Sponsor
Institute	Department of Urooncology, Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization	Asteiias Pharmaceutical. Co.Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 08 Day
Anticipated trial start date	2014 Year 09 Month 05 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

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

Management information
Registered date	2014 Year 04 Month 08 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014898