High Risk Localized Prostate CancerACENCT05303558
A Study of High Risk Localized Prostate Cancer Participants Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
An observational study of High Risk Localized Prostate Cancer, run by Johnson & Johnson International (Singapore) Pte. Ltd. at 9 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival (PFS) probabilities in high-risk localized prostate cancer (HR LPC) participants following radical prostatectomy (RP) and perioperative hormonal therapies (that is, hormonal treatment before RP and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Localized Prostate Cancer
- How many people
- 221 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 24 Aug 2022to 7 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes newly diagnosed adult high-risk localized prostate cancer (HR LPC) participants who received radical prostatectomy (RP) and perioperative hormonal therapy.
Who may be able to join
- Participants who have histologically confirmed adenocarcinoma of the prostate
- Participants newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive)
- Participants fulfil high-risk localized prostate cancer defined by national comprehensive cancer network (NCCN) prostate cancer guideline (2020 version 1) a. T3a or; b. Grade group 4 or Grade group 5 or; c. Prostate specific antigen (PSA) greater than (>) 20 nanograms per milliliter (ng/mL)
- Participants must have received radical prostatectomy (RP) between 1 January 2015 and 30 June 2017
- Participants must have received at least one perioperative hormonal therapy pattern as listed below:
- greater than or equal to (>=) 3 months neoadjuvant hormonal therapy, duration between date of last dose and date of RP should be less than or equal to (<=) 2 months; and/or
- >= 6 months adjuvant hormonal therapy, first dose started within 6 months of RP surgery
Who cannot join
- Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Japan5 sites
Akita University Hospital
Akita, 010-8543
Hirosaki University Hospital
Hirosaki, 036-8563
Nagoya City University Hospital
Nagoya, 467-8602
Yokohama City University Hospital
Yokohama, 236-0004
Yokosuka Kyosai Hospital
Yokosuka, 238-8558
South Korea3 sites
Severance Hospital Yonsei University Health System
Seoul, 03722
Samsung Medical Center
Seoul, 06351
Catholic Medical Center
Seoul, 06591
About this study
Official title: Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
The purpose of this study is to evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival (PFS) probabilities in high-risk localized prostate cancer (HR LPC) participants following radical prostatectomy (RP) and perioperative hormonal therapies (that is, hormonal treatment before RP and / or after RP) over 5 years.
- Conditions
- High Risk Localized Prostate Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With High-risk Localized Prostate Cancer | Adult participants from Japan, South Korea, and Taiwan with high-risk localized prostate cancer (HR LPC) who received radical prostatectomy (RP) and perioperative (neoadjuvant and/ or adjuvant) hormonal therapy will be observed from the date of confirmed HR LPC diagnosis until death, lost to follow-up (last known visit), or end of study period, whichever comes first. This study will utilize data from electronic medical records (EMR) in South Korea and Taiwan, and data from chart reviews in Japan. Data will be analyzed retrospectively from 1 January 2015 to 30 June 2017, with a follow-up till 30 June 2022. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability
PSA PFS probability is defined as probability of being PSA progression free given that participant has yet to experience PSA progression or death from any cause. PSA progression is defined as per the prostate cancer working group 2 (PCWG2) consensus.
Measured: Up to 5 years
Secondary outcomes (5)
Localized Prostate Cancer (LPC) Stage at Diagnosis
LPC stage at diagnosis will be based on the latest tumor nodes and metastases (TNM) staging system approved by the American Joint Committee on Cancer (AJCC).
Measured: Up to 2.5 years
Time from Diagnosis of LPC to Radical Prostatectomy (RP)
Time from diagnosis of LPC to RP will be reported.
Measured: Up to 2.5 years
Number of Participants who Received Treatments Provided with RP and Following RP
Number of participants who received treatments provided with RP and following RP (including RP and neo-adjuvant hormonal therapy only, RP and adjuvant hormonal therapy only, or RP and both neoadjuvant and adjuvant hormonal therapies) will be reported.
Measured: Up to 7.5 years
Hormonal Therapy Duration
Hormonal therapy duration is defined as the length of time between the start date of receiving hormonal therapy treatment and the date of receiving last dose.
Measured: Up to 7.5 years
Yearly Conditional Local or Distant Radiographic PFS Probability
Conditional radiographic PFS probability is defined as the probability of being radiographic progression-free given that participant has yet to experience local or distant radiographic progression.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start24 Aug 2022
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Localized Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson International (Singapore) Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson International (Singapore) Pte Ltd Clinical Trial, Study director, Johnson & Johnson International (Singapore) Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303558
- Sponsor's protocol ID
- CR109188
- Other IDs
- NOPRODPCR4002
- Acronym
- ACE
- Status last verified
- Aug 2024
- First submitted
- 22 Mar 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy
- ClinicalTrials.gov ID
- NCT05303558
- Acronym / sponsor ID
- ACE / CR109188
- Conditions
- High Risk Localized Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Johnson & Johnson International (Singapore) Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival (PFS) probabilities in high-risk localized prostate cancer (HR LPC) participants following radical prostatectomy (RP) and perioperative hormonal therapies (that is, hormonal treatment before RP and / or after RP) over 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants With High-risk Localized Prostate Cancer | – | –Adult participants from Japan, South Korea, and Taiwan with high-risk localized prostate cancer (HR LPC) who received radical prostatectomy (RP) and perioperative (neoadjuvant and/ or adjuvant) hormonal therapy will be observed from the date of confirmed HR LPC diagnosis until death, lost to follow-up (last known visit), or end of study period, whichever comes first. This study will utilize data from electronic medical records (EMR) in South Korea and Taiwan, and data from chart reviews in Japan. Data will be analyzed retrospectively from 1 January 2015 to 30 June 2017, with a follow-up till 30 June 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes newly diagnosed adult high-risk localized prostate cancer (HR LPC) participants who received radical prostatectomy (RP) and perioperative hormonal therapy.
Key inclusion criteria (7 listed)
- Participants who have histologically confirmed adenocarcinoma of the prostate
- Participants newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive)
- Participants fulfil high-risk localized prostate cancer defined by national comprehensive cancer network (NCCN) prostate cancer guideline (2020 version 1) a. T3a or; b. Grade group 4 or Grade group 5 or; c. Prostate specific antigen (PSA) greater than (>) 20 nanograms per milliliter (ng/mL)
- Participants must have received radical prostatectomy (RP) between 1 January 2015 and 30 June 2017
- Participants must have received at least one perioperative hormonal therapy pattern as listed below:
Key exclusion criteria (1 listed)
- Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability
Time frame: Up to 5 years
PSA PFS probability is defined as probability of being PSA progression free given that participant has yet to experience PSA progression or death from any cause. PSA progression is defined as per the prostate cancer working group 2 (PCWG2) consensus.
5 secondary outcomes
Localized Prostate Cancer (LPC) Stage at Diagnosis
Time frame: Up to 2.5 years
Time from Diagnosis of LPC to Radical Prostatectomy (RP)
Time frame: Up to 2.5 years
Number of Participants who Received Treatments Provided with RP and Following RP
Time frame: Up to 7.5 years
Hormonal Therapy Duration
Time frame: Up to 7.5 years
Yearly Conditional Local or Distant Radiographic PFS Probability
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson International (Singapore) Pte Ltd Clinical Trial study director
Johnson & Johnson International (Singapore) Pte. Ltd.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk Localized Prostate Cancer, run by Johnson & Johnson International (Singapore) Pte. Ltd. at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yearly Conditional Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Probability (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.