UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047622 |
|---|---|
| Receipt number | R000054229 |
| Scientific Title | Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/05/02 09:27:03 |
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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
asingh15@its.jnj.com
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Hosokawa |
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
08040924367
Homepage URL
Maki.Hosokawa@iqvia.com
Sponsor or person
Institute
Johnson & Johnson International (Singapore) Pte. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson International (Singapore) 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
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
77
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
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
| 2023 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054229
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