臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 25, 2019
Last modified on	June. 17, 2024
Trial ID	jRCTs021180021

Scientific Title	Upfront abiraterone and docetaxel in patients with high-risk metastatic hormone naive prostate cancer (UFAD in mHNPC)
Public Title	Upfront therapy in high risk metastatic prostate cancer (UFAD in mHNPC)

Contact for Scientific Queries	Name	Narita Shintaro
	Affiliation	Akita University School of Medicine
	Address	1-1-1 Hondo, Akita, Akita
	Telephone	+81-18-884-6156
	E-mail	naritashintaro@gmail.com
Contact for Public Queries	Name	Narita Shintaro
	Affiliation	Akita University School of Medicine
	Address	1-1-1 Hondo, Akita, AKita
	Telephone	+81-18-884-6156
	E-mail	naritashintaro@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 05, 2016
Actual date of first enrollment		April. 01, 2016
Target sample size		100
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who meet the criteria as described below will be included: 1. Historically confirmed prostate cancer 2. Metastatic disease on radiographic examinations without any initial treatment 3. 20 years and older 4. ECOG performance status 0-2 5. Plan to receive androgen-deprivation therapy including leuteinizing hormone-releasing hormone (LHRH) agonist, LHRH antagonist, surgical castration with and without bicalutamide 6. Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria Leukocyte counts >= 3,000/mm3 NPlatelets >= 750,000/mm3 Hemoglobin concentration >= 9.0 g/dL AST <= 90IU ALT <= 100IU Total bilirubin <=2.0mg/dL. Serum creatinine, <= 3.0mg/dL 7. Agree with the protocol with signed informed consent
	Exclusion Criteria	Patients who meet the criteria below will be excluded: 1.Severe cardiovascular disease and diabetes mellitus 2.Chronic pulmonary disease 3.Allergy to taxanes 4. Active concomitant malignancy 5. Difficulty of understanding of the trial because of mental disease 6.Inappropriate patients for this study judged by the physicians
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		metastatic hormone naive prostate cancer
Intervention(s)		patients are assigned to the three groups including ADT, ADT+abiraterone, and ADT+docetaxel according to the patient's preference.
Health Condition(s) Keyword		prostate cancer, hormone naive, metastatic
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Metastatic free survival
Secondary Outcome(s)		Complete serologic response rate, cancer specific survival, overall survival, adverse event, pain score and frequency of skeltal related event, QOL

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Clinical Research Review Board,Akita University
Address	Hasunuma,Hiroomote 44-2,Akita 010-8543,Japan, Akita
Telephone	+81-18-884-6461
E-Mail	nintei@hos.akita-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 04, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
11	June. 17, 2024	(this page)	Changes
10	Mar. 29, 2024	Detail	Changes
9	Nov. 10, 2023	Detail	Changes
8	June. 08, 2022	Detail	Changes
7	May. 10, 2022	Detail	Changes
6	May. 25, 2021	Detail	Changes
5	Feb. 18, 2021	Detail	Changes
4	Aug. 07, 2020	Detail	Changes
3	Nov. 25, 2019	Detail	Changes
2	Aug. 09, 2019	Detail	Changes
1	Mar. 25, 2019	Detail

List of change history