Asia Study Group of Prostate Cancer (A-CaP Study)

August 5, 2019 updated by: Hideyuki Akaza, Japan Study Group of Prostate Cancer

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Meguro-ku
      • Tokyo, Meguro-ku, Japan, 153-8904
        • The University of Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Prostate cancer patients

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• Patients for whom information about the time of diagnosis, including histopathological diagnosis, cannot be acquired.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prostate Cancer
About 20,000 patients who have received a histopathological diagnosis of prostate cancer from ten countries in Asia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

The short form 36 (SF-36) is used for an evaluation indicator of patient QOL. SF-36 includes the following eight elements.

  1. Physical functioning
  2. Role functioning Physical
  3. Bodily pain
  4. General health
  5. Vitality
  6. Social functioning
  7. Role functioning emotional
  8. 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.
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Study Group of Prostate Cancer

Investigators

  • Study Director: Hideyuki Akaza, M.D., Ph.D., J-CaP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-CaP2015-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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