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

• Conditions: Prostate Cancer

• Registration Number: NCT02873013
• Lead Sponsor: Japan Study Group of Prostate Cancer

Brief 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. 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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Primary Completion: 2019-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients background at time of diagnosis of prostate cancer, treatment progress and prognosis with the reason for progression and subsequent treatment methods	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.

Secondary Outcome Measures

Name	Time	Method
Patient QOL measured by SF-36 during treatment by comparison with A-Cap data and data in the United States and Australia	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.

Trial Locations

Locations (1)

The University of Tokyo; 🇯🇵 Tokyo, Meguro-ku, Japan