UMIN-CTR Clinical Trial

Basic information
Public title	Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
Acronym	ACE Study
Scientific Title	Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
Scientific Title:Acronym	ACE Study
Region	Japan Asia(except Japan)

Condition
Condition	High Risk Localized Prostate Cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Describe real-world clinical characteristics, treatment pathways, and outcomes in HR LPC patients from Japan, South Korea, and Taiwan
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Among HR LPC patients following RP and perioperative hormonal therapies: Evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival probabilities over 5 years
Key secondary outcomes	Among HR LPC patients following RP and perioperative hormonal therapies: Secondary objective #1: Describe patient characteristics (including stage at diagnosis and time from diagnosis to RP) Secondary objective #2: Describe treatments provided with RP and following RP including: a.Treatments received (RP and neo-adjuvant hormonal therapy only, RP and adjuvant hormonal therapy only, or RP and both neo-adjuvant and adjuvant hormonal therapies) b.Hormonal therapy duration Secondary objective #3: Evaluate the yearly local or distant radiographic progression-free survival probabilities over 5 years Exploratory objective #1 (if data permits): Evaluate median time to PSA progression Exploratory objective #2 (if data permits): Describe rate of pathologic complete response (pCR) in HR LPC patients who received RP and: a.neoadjuvant hormonal therapy only b.adjuvant hormonal therapy only c.both neoadjuvant and adjuvant hormonal therapies Exploratory objective #3 (if data permits): Describe rate of negative margin in HR LPC patients who received RP and: a.neoadjuvant hormonal therapy only b.adjuvant hormonal therapy only c.both neoadjuvant and adjuvant hormonal therapies Exploratory objective #4 (if data permits): Describe rate of HR LPC patients receiving RP and hormonal therapies among: a.newly diagnosed HR LPC patients b.newly diagnosed HR LPC patients who received RP

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1.>=18 years of age at time of LPC diagnosis 2.Histologically confirmed adenocarcinoma of the prostate 3.Newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive) 4.High risk localized prostate cancer, as defined by NCCN prostate cancer guideline (2020 version 1) 5.Must have received radical prostatectomy between 1 January 2015 and 30 June 2017 6.Must have received at least 1 perioperative hormonal therapy pattern: a.>=3 months neoadjuvant hormonal therapy, duration between date of last dose and date of RP should be <=2 months; AND / OR b.>=6 months adjuvant hormonal therapy, first dose started within 6 months of RP surgery
Key exclusion criteria	Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Anildeep Middle name Last name Singh
Organization	Regional Medical Affairs
Division name	Regional Medical Affairs
Zip code	118222
Address	2 Science Park Drive, #07-13, Ascent, Singapore
TEL	+60(3)76614603
Email	asingh15@its.jnj.com

Public contact
Name of contact person	1st name Ryo Middle name Last name Hanaoka
Organization	IQVIA Services Japan K.K.
Division name	Real World Evidence Services
Zip code	1080074
Address	Keikyu Dai-1 Building 4-10-18 Takanawa, Minato-ku, Tokyo
TEL	08071894579
Homepage URL
Email	ryo.hanaoka@iqvia.com

Sponsor
Institute	Johnson & Johnson Pte. Ltd
Institute
Department

Funding Source
Organization	Johnson & Johnson Pte. Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NPO MINS Ethics Committee
Address	2F, ST Shibuya Building 15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel	0364161868
Email	npo-mins@j-irb.com

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	2022 Year 05 Month 01 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	Preinitiation
Date of protocol fixation	2021 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 30 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is a real world, retrospective cohort study for HR LPC patients from Japan, South Korea and Taiwan. Electronic medical record (EMR) databases from selected Korean medical centers and multi-hospital databases in Taiwan will be analyzed to produce aggregated country-level outputs. In parallel, a chart review will be conducted at selected tertiary hospitals in Japan to develop a study-specific database. The statistical outputs from the Japan study-specific database will be meta-analyzed with the country-level outputs from South Korea and Taiwan to produce a study report. This study population includes newly diagnosed adult HR LPC patients with follow-up until 30 June 2022.

Management information
Registered date	2022 Year 04 Month 28 Day
Last modified on	2022 Year 04 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054229

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.