Clinical trial NCT02873013: Asia Study Group of Prostate Cancer (A-CaP Study)
Official title: Research Concerning Background Factors at Time of Diagnosis and Initial Treatment and Treatment Progress Cancer Patients in Asia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prostate Cancer
Keywords: prostate cancer
observational study
Lead sponsor: Japan Study Group of Prostate Cancer
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 20000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patients background at time of diagnosis of prostate cancer, treatment progress and prognosis with the reason for progression and subsequent treatment methods
timeFrame: three years
Secondary outcomes:
measure: Patient QOL measured by SF-36 during treatment by comparison with A-Cap data and data in the United States and Australia
timeFrame: three years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: The University of Tokyo
state: Meguro-ku
Study officials:
affiliation: J-CaP
name: Hideyuki Akaza, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Cooperberg 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.