NCT02873013

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

July 12, 2016

Last Update Submit

August 5, 2019

Conditions

Prostate Cancer

Keywords

prostate cancerobservational study

Outcome Measures

Primary Outcomes (1)

  • 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. 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 Outcomes (1)

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

    three years

Study Arms (1)

Prostate Cancer

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

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prostate cancer patients

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Tokyo

Tokyo, Meguro-ku, 153-8904, Japan

Location

Related Publications (2)

  • 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.

    PMID: 25098707BACKGROUND

  • 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.

    PMID: 19667269BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Hideyuki Akaza, M.D., Ph.D.

    J-CaP

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

August 19, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2026

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)