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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047622 |
Receipt No. | 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 | 2022/04/28 |
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 |
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Condition | ||
Condition | High Risk Localized Prostate Cancer | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 |
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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 | |||||||
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 |
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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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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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 |
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Last modified on |
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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 | |
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Research case data | |
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