Prostate CancerNCT02873013
Asia Study Group of Prostate Cancer (A-CaP Study)
An observational study of Prostate Cancer, run by Japan Study Group of Prostate Cancer at 1 site in Japan.
Trial summary
This study will target patients who have received a histopathological diagnosis of prostate cancer and who are undergoing treatment in various forms, including active PSA surveillance, surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 20,000 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2016to Mar 2026
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prostate cancer patients
Who may be able to join
- Patients who have received a histopathological diagnosis of prostate cancer between January 1,2016,and December 31,2018.
- Patients who, having received a diagnosis within the abovementioned period, began initial treatment for prostate cancer(including active surveillance).
- Patients who are either hospitalized as outpatients.
Who cannot join
- Patients for whom information about the time of diagnosis, including histopathological diagnosis, cannot be acquired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Concerning Background Factors at Time of Diagnosis and Initial Treatment and Treatment Progress Cancer Patients in Asia
This study will target patients who have received a histopathological diagnosis of prostate cancer and who are undergoing treatment in various forms, including active PSA surveillance, surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. The study will survey information about the patient at time of diagnosis, clinical staging, details of initial treatment, status of disease progression, and prognosis at the end point of the study. The purpose of the study is to clarify distribution of staging, the actual status of treatment choices and treatment outcomes.
Read the detailed description
The A-CaP will collect information in a linkable anonymized format from all medical institutions in Asian countries participating in the study and will engage in data analysis. J-CaP which has previous experience of engaging in a similar study in 2010 wll be a sponsor for A-CaP study, the aggregated results of which have been reported. The registration period for this study will be three years followed by 7 years of follow-up study, and research will be implemented across a wider range of Asian countries, with new institutions participating for the purposes of this study. As this study will be an observational study the acquisition of data will be relatively simple, and as the content of the study will be almost identical to the study conducted by J-CaP in 2010, a system for research implementation is already established at J-CaP.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, observational study
- Medical subject headings
- Prostatic Neoplasms
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 |
|---|---|---|
| Prostate Cancer | About 20,000 patients who have received a histopathological diagnosis of prostate cancer from ten countries in Asia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients background at time of diagnosis of prostate cancer, treatment progress and prognosis with the reason for progression and subsequent treatment methods
The following items are examined for primary outcome measure.
- Patient background which is represented by month and year of birth; height and weight; ethnicity and family history; medical history; and name of condition/disease for which currently receiving treatment at hospital.
- Information pertaining to prostate cancer which is represented by PSA value at time of prostate cancer diagnosis and Gleason score.
- Prognosis information which is survival or death at end point of the Study.
Measured: three years
Secondary outcomes (1)
Patient QOL measured by SF-36 during treatment by comparison with A-Cap data and data in the United States and Australia
The short form 36 (SF-36) is used for an evaluation indicator of patient QOL. SF-36 includes the following eight elements.
- Physical functioning
- Role functioning Physical
- Bodily pain
- General health
- Vitality
- Social functioning
- Role functioning emotional
- Mental health
More detailed questions are prepared under the above each eight element, which a score is produced for a quantitative outcome of the patients QOL.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2019
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Study Group of Prostate Cancer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hideyuki Akaza, Japan Study Group of Prostate Cancer
- Investigators
- Hideyuki Akaza, M.D., Ph.D., Study director, J-CaP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873013
- Sponsor's protocol ID
- A-CaP2015-2026
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2016
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Onozawa M, Hinotsu S, Tsukamoto T, Oya M, Ogawa O, Kitamura T, Suzuki K, Naito S, Namiki M, Nishimura K, Hirao Y, Akaza H. Recent trends in the initial therapy for newly diagnosed prostate cancer in Japan. Jpn J Clin Oncol. 2014 Oct;44(10):969-81. doi: 10.1093/jjco/hyu104. Epub 2014 Aug 6.
PubMed 25098707Cooperberg MR, Hinotsu S, Namiki M, Ito K, Broering J, Carroll PR, Akaza H. Risk assessment among prostate cancer patients receiving primary androgen deprivation therapy. J Clin Oncol. 2009 Sep 10;27(26):4306-13. doi: 10.1200/JCO.2008.21.5228. Epub 2009 Aug 10.
PubMed 19667269
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Concerning Background Factors at Time of Diagnosis and Initial Treatment and Treatment Progress Cancer Patients in Asia
- ClinicalTrials.gov ID
- NCT02873013
- Acronym / sponsor ID
- A-CaP2015-2026
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Japan Study Group of Prostate CancerUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- 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.
This study will target patients who have received a histopathological diagnosis of prostate cancer and who are undergoing treatment in various forms, including active PSA surveillance, surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. The study will survey information about the patient at time of diagnosis, clinical staging, details of initial treatment, status of disease progression, and prognosis at the end point of the study. The purpose of the study is to clarify distribution of staging, the actual status of treatment choices and treatment outcomes.
Detailed description
The A-CaP will collect information in a linkable anonymized format from all medical institutions in Asian countries participating in the study and will engage in data analysis. J-CaP which has previous experience of engaging in a similar study in 2010 wll be a sponsor for A-CaP study, the aggregated results of which have been reported. The registration period for this study will be three years followed by 7 years of follow-up study, and research will be implemented across a wider range of Asian countries, with new institutions participating for the purposes of this study. As this study will be an observational study the acquisition of data will be relatively simple, and as the content of the study will be almost identical to the study conducted by J-CaP in 2010, a system for research implementation is already established at J-CaP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | – | –About 20,000 patients who have received a histopathological diagnosis of prostate cancer from ten countries in Asia. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prostate cancer patients
Key inclusion criteria (3 listed)
- Patients who have received a histopathological diagnosis of prostate cancer between January 1,2016,and December 31,2018.
- Patients who, having received a diagnosis within the abovementioned period, began initial treatment for prostate cancer(including active surveillance).
- Patients who are either hospitalized as outpatients.
Key exclusion criteria (1 listed)
- Patients for whom information about the time of diagnosis, including histopathological diagnosis, cannot be acquired.
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
Patients background at time of diagnosis of prostate cancer, treatment progress and prognosis with the reason for progression and subsequent treatment methods
Time frame: three years
The following items are examined for primary outcome measure. 1. Patient background which is represented by month and year of birth; height and weight; ethnicity and family history; medical history; and name of condition/disease for which currently receiving treatment at hospital. 2. Information pertaining to prostate cancer which is represented by PSA value at time of prostate cancer diagnosis and Gleason score. 3. Prognosis information which is survival or death at end point of the Study.
1 secondary outcome
Patient QOL measured by SF-36 during treatment by comparison with A-Cap data and data in the United States and Australia
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 25098707Onozawa M, Hinotsu S, Tsukamoto T, Oya M, Ogawa O, Kitamura T, Suzuki K, Naito S, Namiki M, Nishimura K, Hirao Y, Akaza H. Recent trends in the initial therapy for newly diagnosed prostate cancer in Japan. Jpn J Clin Oncol. 2014 Oct;44(10):969-81. doi: 10.1093/jjco/hyu104. Epub 2014 Aug 6.
- Background: PubMed 19667269Cooperberg MR, Hinotsu S, Namiki M, Ito K, Broering J, Carroll PR, Akaza H. Risk assessment among prostate cancer patients receiving primary androgen deprivation therapy. J Clin Oncol. 2009 Sep 10;27(26):4306-13. doi: 10.1200/JCO.2008.21.5228. Epub 2009 Aug 10.
- 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.
Hideyuki Akaza, M.D., Ph.D. study director
J-CaP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Japan Study Group of Prostate Cancer at 1 site in Japan.
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 3 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: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Results are not available in the source record.
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?
Patients background at time of diagnosis of prostate cancer, treatment progress and prognosis with the reason for progression and subsequent treatment methods (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02873013, which also lists 2 linked publications.
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 7 Aug 2019.