the prevalence of prostate cancer in korea quadrupled between 2002 and 2008 , with the highest increased incidence rate in total forms of malignancy .
the incidence of prostate cancer in korea increased up to 24.8 per 100,000 men in 2009 in comparison with 13 per 100,000 men in 2008 .
certain environmental elements have had an effect on the increased rate of prostate cancer , including the transition to western dietary habits among koreans and an aging population because of the rise in average life expectancy .
in addition to environmental causes , the medical development of laboratory diagnoses and prostate - specific antigen screening campaigns by the korean urological association and other health organizations have helped to raise public awareness about the increase in prostate cancer in koreans . despite the rapid increase in prostate cancer incidence in korea ,
no published multicenter data on practical and clinical changes in korean patients with prostate cancer are available . in the united states , a database application project known as the cancer of the prostate strategic urologic research endeavor ( capsure ) was initiated in 1995 to establish a web - based database for longitudinal observations of prostate cancer patients in natural settings .
the project began with 10 participating healthcare centers and increased to 26 centers in 1 year .
currently , capsure is one of the most powerful prospective study groups for prostate cancer in the world consisting of approximately 14,000 registered prostate cancer patients .
the most recent database study in asia , the japan study group for prostate cancer ( j - cap ) , was developed in 2001 .
the j - cap database comprises 17,872 prostate cancer patients from prospective studies and was developed to improve patient care . against this background , the multicenter korean prostate cancer database ( k - cap )
was created in 2011 by combining several urologic healthcare institutions into a nationwide multicenter database for prospective studies about prostate cancer .
the purpose of k - cap is to gather basic information about korean prostate cancer patients and analyze the clinical and oncological outcomes of prostate cancer to improve patient care .
the purpose of this article was to declare the establishment of k - cap , to provide urologists with an overview of the k - cap methodology , and to present pilot test results from the first umbrella database comprising patient information from three participating institutions ( gangnam severance hospital , seoul st .
participating institutions include asan medical center , samsung medical center , seoul national university bundang hospital , seoul st .
any institution that wants to participate in k - cap must first obtain approval from their ethics committees ( or institutional review board ) .
for every eligible institution , all patients with newly diagnosed prostate cancer will be registered in the k - cap web - based electronic server .
all registered patient information will be updated periodically . after a diagnosis of prostate cancer , patients are invited by their urologists to join the study .
all patients with biopsy - proven prostate cancer are offered enrollment in the study , regardless of disease stage , severity , or type of treatment .
included in the database is all of the physician - gathered general information about a patient , including sociodemographic data .
in addition , all of the patient 's clinical information at diagnosis is gathered , including diagnostic imaging , laboratory test results , pre - existing and postdiagnosis comorbidities , medical history , treatment types ( e.g. , active surveillance , androgen deprivation / hormonal medications , brachytherapy , cryotherapy , external beam radiation , hormone refractory and chemotherapy agents , and radical prostatectomy ) , neoadjuvant and adjuvant treatments , and other nontreatment - related medications . for patients who have undergone radical prostatectomy ,
detailed perioperative variables are measured and registered , including procedure types , intraoperative or postsurgical complications , surgical pathology results , and clinical and oncological survival outcomes .
the patient files for the k - cap database include approximately 1,000 required clinical variables .
the observational study of prostate cancer patients is the ultimate goal of the k - cap database .
accordingly , the web - based electronic case report form ( e - crf ) was developed by using the startrial system , which is a commercially developed electronic data capture system .
this e - crf system can be accessed over the internet on a 24-hour basis by coordinators and investigators at eight participating clinics ( suppl .
the system was developed at the catholic university of korea , south korea , and was previously tested with the help of staff at other participating sites .
the database system was implemented with a microsoft sql server running on microsoft nt servers and was programmed with java .
this was accomplished by directly partnering the electronic databases of the study 's participating institutions with the registered patient files .
all legal requirements for privacy protection were respected in this procedure . according to the privacy rules of k - cap , cases for registered patients are to be updated once every 3 months in terms of test dates , changes in treatment , and progress data as a matter of course for maintaining the k - cap patient forms until death or patient withdrawal .
follow - up with respect to morbidity and death from prostate cancer is assured by cooperation with national statistics .
when patients die , the date , location , and cause of death are recorded in the database .
after completion of the data control for registered patients , analytic reports are prepared for prospective studies and research to improve the care of prostate cancer patients .
these data summaries evaluate clinical occurrences , patient quality of life , economic impact , and oncological outcomes and compare types of treatment by stage and practice among patients with prostate cancer in korea .
the complex studies use well - sorted variables from the k - cap database , together with adjustment methods including case controls , standardization , regression trees , and multivariate regression approaches for optimal analysis .
the entry form contains five categories : patient demographics , clinical parameters , pathological parameters , other treatment parameters ( hormone therapy or radiotherapy ) , and parameters associated with follow - up .
access given to an investigator allows extraction of only his or her patient 's data .
the data format for data extraction includes csv format , ms excel ( xls format ) , or ms access ( accdb format ) .
the system manager is able to select data by accessing the sql server system directly using the sql program ( suppl .
2 ) . to ensure the quality of the database , it is most important that accurate data be provided by the investigators . however , if a strange code is entered into the database , the database system automatically checks the input code and will not process the input of the strange data set .
investigators are also able to compare their own raw data with data in the k - cap database at anytime , because each institution 's data can be extracted if the investigator has access rights .
a pilot test was performed to determine whether to use the standard e - crf system based on the limited perioperative information of prostate cancer patients who underwent radical prostatectomy . between january 2006 and december 2010 , 858 prostate cancer patients who underwent radical prostatectomy at three institutions ( gangnam severance hospital , seoul st .
mary 's hospital , or seoul national university bundang hospital ) were registered in the e - crf system of k - cap .
the database collected preoperative variables , including patient age , prostate - specific antigen level at diagnosis , preoperative gleason score , clinical stage , and the initial procedure chosen for radical prostatectomy .
postoperative variables were also registered , including pathologic gleason score and stage . for each patient , the t stage was determined in accordance with tumor - node - metastasis ( tnm ) categories , as published in 2010 ( american joint committee on cancer , 7th edition ) .
all of the pathologic parameters that influence the determination of tnm staging were registered in detail .
the first step was to gather the prostate cancer database files from each institution using the excel format and to send these files to an e - crf system manager controlling the data input / output of the web - based database .
subsequently , the manager converted the coded excel files for use in the e - crf system . finally , we were able to obtain outcomes from the multicenter e - crf database according to several conditions that we initially established to fit the goals of k - cap .
participating institutions include asan medical center , samsung medical center , seoul national university bundang hospital , seoul st .
any institution that wants to participate in k - cap must first obtain approval from their ethics committees ( or institutional review board ) .
for every eligible institution , all patients with newly diagnosed prostate cancer will be registered in the k - cap web - based electronic server .
participating institutions include asan medical center , samsung medical center , seoul national university bundang hospital , seoul st .
eligible institutions include all urologic institutions in korea . any institution that wants to participate in k - cap
for every eligible institution , all patients with newly diagnosed prostate cancer will be registered in the k - cap web - based electronic server .
after a diagnosis of prostate cancer , patients are invited by their urologists to join the study .
all patients with biopsy - proven prostate cancer are offered enrollment in the study , regardless of disease stage , severity , or type of treatment . included in the database
is all of the physician - gathered general information about a patient , including sociodemographic data . in addition , all of the patient 's clinical information at diagnosis is gathered , including diagnostic imaging , laboratory test results , pre - existing and postdiagnosis comorbidities , medical history , treatment types ( e.g. , active surveillance , androgen deprivation / hormonal medications , brachytherapy , cryotherapy , external beam radiation , hormone refractory and chemotherapy agents , and radical prostatectomy ) , neoadjuvant and adjuvant treatments , and other nontreatment - related medications . for patients who have undergone radical prostatectomy ,
detailed perioperative variables are measured and registered , including procedure types , intraoperative or postsurgical complications , surgical pathology results , and clinical and oncological survival outcomes .
the patient files for the k - cap database include approximately 1,000 required clinical variables .
the observational study of prostate cancer patients is the ultimate goal of the k - cap database .
accordingly , the web - based electronic case report form ( e - crf ) was developed by using the startrial system , which is a commercially developed electronic data capture system .
this e - crf system can be accessed over the internet on a 24-hour basis by coordinators and investigators at eight participating clinics ( suppl .
the system was developed at the catholic university of korea , south korea , and was previously tested with the help of staff at other participating sites .
the database system was implemented with a microsoft sql server running on microsoft nt servers and was programmed with java .
this was accomplished by directly partnering the electronic databases of the study 's participating institutions with the registered patient files .
all legal requirements for privacy protection were respected in this procedure . according to the privacy rules of k - cap , cases for registered patients are to be updated once every 3 months in terms of test dates , changes in treatment , and progress data as a matter of course for maintaining the k - cap patient forms until death or patient withdrawal .
follow - up with respect to morbidity and death from prostate cancer is assured by cooperation with national statistics .
when patients die , the date , location , and cause of death are recorded in the database .
after completion of the data control for registered patients , analytic reports are prepared for prospective studies and research to improve the care of prostate cancer patients .
these data summaries evaluate clinical occurrences , patient quality of life , economic impact , and oncological outcomes and compare types of treatment by stage and practice among patients with prostate cancer in korea .
the complex studies use well - sorted variables from the k - cap database , together with adjustment methods including case controls , standardization , regression trees , and multivariate regression approaches for optimal analysis .
the entry form contains five categories : patient demographics , clinical parameters , pathological parameters , other treatment parameters ( hormone therapy or radiotherapy ) , and parameters associated with follow - up .
access given to an investigator allows extraction of only his or her patient 's data .
the data format for data extraction includes csv format , ms excel ( xls format ) , or ms access ( accdb format ) .
the system manager is able to select data by accessing the sql server system directly using the sql program ( suppl .
2 ) . to ensure the quality of the database , it is most important that accurate data be provided by the investigators . however , if a strange code is entered into the database , the database system automatically checks the input code and will not process the input of the strange data set .
investigators are also able to compare their own raw data with data in the k - cap database at anytime , because each institution 's data can be extracted if the investigator has access rights .
after a diagnosis of prostate cancer , patients are invited by their urologists to join the study .
all patients with biopsy - proven prostate cancer are offered enrollment in the study , regardless of disease stage , severity , or type of treatment . included in the database
is all of the physician - gathered general information about a patient , including sociodemographic data . in addition , all of the patient 's clinical information at diagnosis is gathered , including diagnostic imaging , laboratory test results , pre - existing and postdiagnosis comorbidities , medical history , treatment types ( e.g. , active surveillance , androgen deprivation / hormonal medications , brachytherapy , cryotherapy , external beam radiation , hormone refractory and chemotherapy agents , and radical prostatectomy ) , neoadjuvant and adjuvant treatments , and other nontreatment - related medications . for patients who have undergone radical prostatectomy ,
detailed perioperative variables are measured and registered , including procedure types , intraoperative or postsurgical complications , surgical pathology results , and clinical and oncological survival outcomes .
the patient files for the k - cap database include approximately 1,000 required clinical variables .
the observational study of prostate cancer patients is the ultimate goal of the k - cap database .
accordingly , the web - based electronic case report form ( e - crf ) was developed by using the startrial system , which is a commercially developed electronic data capture system .
this e - crf system can be accessed over the internet on a 24-hour basis by coordinators and investigators at eight participating clinics ( suppl .
the system was developed at the catholic university of korea , south korea , and was previously tested with the help of staff at other participating sites .
the database system was implemented with a microsoft sql server running on microsoft nt servers and was programmed with java .
this was accomplished by directly partnering the electronic databases of the study 's participating institutions with the registered patient files .
according to the privacy rules of k - cap , cases for registered patients are to be updated once every 3 months in terms of test dates , changes in treatment , and progress data as a matter of course for maintaining the k - cap patient forms until death or patient withdrawal . follow - up with respect to morbidity and death from prostate cancer is assured by cooperation with national statistics .
when patients die , the date , location , and cause of death are recorded in the database .
after completion of the data control for registered patients , analytic reports are prepared for prospective studies and research to improve the care of prostate cancer patients .
these data summaries evaluate clinical occurrences , patient quality of life , economic impact , and oncological outcomes and compare types of treatment by stage and practice among patients with prostate cancer in korea .
the complex studies use well - sorted variables from the k - cap database , together with adjustment methods including case controls , standardization , regression trees , and multivariate regression approaches for optimal analysis .
the entry form contains five categories : patient demographics , clinical parameters , pathological parameters , other treatment parameters ( hormone therapy or radiotherapy ) , and parameters associated with follow - up .
access given to an investigator allows extraction of only his or her patient 's data .
the data format for data extraction includes csv format , ms excel ( xls format ) , or ms access ( accdb format ) .
the system manager is able to select data by accessing the sql server system directly using the sql program ( suppl .
to ensure the quality of the database , it is most important that accurate data be provided by the investigators .
however , if a strange code is entered into the database , the database system automatically checks the input code and will not process the input of the strange data set .
investigators are also able to compare their own raw data with data in the k - cap database at anytime , because each institution 's data can be extracted if the investigator has access rights .
a pilot test was performed to determine whether to use the standard e - crf system based on the limited perioperative information of prostate cancer patients who underwent radical prostatectomy . between january 2006 and december 2010 , 858 prostate cancer patients who underwent radical prostatectomy at three institutions ( gangnam severance hospital , seoul st .
mary 's hospital , or seoul national university bundang hospital ) were registered in the e - crf system of k - cap .
the database collected preoperative variables , including patient age , prostate - specific antigen level at diagnosis , preoperative gleason score , clinical stage , and the initial procedure chosen for radical prostatectomy .
postoperative variables were also registered , including pathologic gleason score and stage . for each patient , the t stage was determined in accordance with tumor - node - metastasis ( tnm ) categories , as published in 2010 ( american joint committee on cancer , 7th edition ) .
all of the pathologic parameters that influence the determination of tnm staging were registered in detail .
the first step was to gather the prostate cancer database files from each institution using the excel format and to send these files to an e - crf system manager controlling the data input / output of the web - based database .
subsequently , the manager converted the coded excel files for use in the e - crf system . finally , we were able to obtain outcomes from the multicenter e - crf database according to several conditions that we initially established to fit the goals of k - cap
the multicenter k - cap test database , which contains data for a total of 858 prostate cancer patients who underwent radical prostatectomy at three institutions , represents a single source for comprehensive information about the patients and the disease .
a java program was developed to upload excel data into the e - crf database by matching each column name .
if the uploaded excel file executes the java program , the data is automatically entered into the designated column .
the first step is to compare the number of records between the uploaded excel file and the sql server database .
the second step is to transform data from the sql server into excel format and then compare it with the original data set .
we confirmed that the process of converting data to the e - crf system from excel files is easy and exact and that output data from the web - based database system are quickly retrievable according to many weighted limitations .
complete treatment histories and patient information allow for comparison of different outcomes . as the number of patients enrolled in the database increases , the database will help to categorize patients and identify historical controls for various purposes . in existing research about prostate cancer
, patients have been selected with indiscriminate consideration of treatment type or stage , regardless of the varying aims of specific studies .
for example , the life expectancy of korean prostate cancer patients with multiple bone metastases is not yet known .
in addition , we do not yet know the exact clinical course of korean prostate cancer patients after treatment .
even though we reviewed the results of many studies and made conclusions about disease progression [ 7 - 12 ] , the results were from single - institution cohort studies with small sample sizes .
furthermore , despite the many studies of prostate cancer in koreans , most of our knowledge is still based on studies from a western database of prostate cancer .
thus , we needed a prostate cancer database of our own , and we believe that k - cap is that database . however , under a system of longitudinal observation , the collection of visible results for analysis will require more time than is required for studies focusing on retrospective design .
we expect that at least 5 years will be required to obtain tangible and qualitative results from the k - cap database .
if the initial results are positive , however , lasting products will exist in the database on an ongoing basis . in the case of capsure
, the first published results about trends in prostate cancer treatment ( 2003 ) were published 7 years after initial development of the capsure project .
currently , a pubmed search with the term " capsure " delivers more than 100 relevant articles , including articles on the j - cap project in japan .
achievement of this long - term plan requires verification of the web - based database system as the first step toward the establishment of k - cap .
the pilot test with prostate cancer patient databases from three institutions showed the feasibility of a web - based system for k - cap .
the important checkpoint is that the results of the pilot test are not intended to be used to make analytical conclusions about the specific subjects from the three institutions .
the intent of the pilot test was to ensure that the k - cap database system was operating accurately before other participating institutions provided proprietary data .
as this article goes to press , patient data from the remaining institutions in the korean healthcare system are being registered .
we estimate that approximately 4,000 cases from participating institutions will be registered as the basic background data for the k - cap database ( 620 patients from asan medical center , j.h.h .
, c.s.k . ; 1,400 patients from samsung medical center , h.m.l . ; 340 patients from seoul national university bundang hospital , s.k.h .
the patients with newly diagnosed prostate cancer from the participating institutions will be registered , including the required entry information for k - cap . according to the patients ' privacy agreement
, basic information about the patients will be encrypted by using a program unique to the k - cap database and will remain unknown to our team and even to the database manager .
thus , the privacy of the patients registered in k - cap is guaranteed . developing a uniform format for the k - cap database was one of the main concerns of the project staff at each of the participating institutions .
for example , because of different policies at each institution , differences in preoperative prostate volume measurements ( by transrectal ultrasonography ) existed between the participating institutions .
some institutions measured prostate volume preoperatively in all patients , but the procedure was performed at different clinical stages at some institutions .
furthermore , each institution had different postoperative follow - up periods over which to conduct patient orientation surveys , such as the international index of erectile function questionnaire .
in addition to policy differences between the institutions , internal problems concerning a uniform database format also existed .
some pathologists reported the precise weights of the tumors in grams , whereas others reported approximate volumes using relative measurements ( e.g. , v1 , v2 , and v3 ) .
importantly , we previously identified several problems , such as those mentioned above , and have discussed solutions intended to achieve a uniform format for the database
. we will continue to revise and develop the k - cap format in an effort to provide the flexibility needed to achieve the long - term goals of the database .
another important consideration in the management of the k - cap database is how best to maintain continuous updates about patients .
it is difficult to predict how many new prostate cancer patients from each participating institution will be enrolled in k - cap .
likewise , it is difficult to update k - cap data periodically if the number of enrolled patients is too large , even before the k - cap settings are ready .
however , it is well known that the design of a longitudinal observational study ensures that the quality of the data is more important than the quantity of the data . to solve this problem
, we enrolled a limited number of prostate cancer patients representative of a particular institution rather than all of the prostate cancer patients at that institution . after determining the appropriate k - cap settings through trial and error
, we intend to enroll all prostate cancer patients in the k - cap database and to include patients from any institution that wants to participate in k - cap .
one last consideration is the importance of k - cap 's collaboration with capsure and j - cap .
k - cap is intended to be used not only for domestic investigation but also for international participation and collaboration . even though k - cap is still in the preparatory stage ,
we have already received valuable advice and support from the working staff and chairmen of capsure and j - cap .
collaboration will best be achieved if the format of the k - cap database is analogous to that of the other databases .
the k - cap database was developed considering the original excel database of capsure and j - cap .
the capsure database has many variables , for which each treatment of prostate cancer was equally taken into account .
this probably reflects the different trends in prostate cancer treatment between the united states and japan .
the ability to reference these different databases will help to enrich the k - cap database , so that our database can cover many fields . in this article
, we announced the establishment of k - cap on behalf of all the participants in the k - cap project .
the main purpose of k - cap is to establish and maintain a large database of randomized clinical trials and observational longitudinal studies of korean prostate cancer patients .
several retrospective studies about prostate cancer in korea have been published in domestic and international journals .
we believe that mutual cooperation is needed to establish the k - cap project as being equal to the capsure and j - cap projects in the united states and japan , respectively .
although our beginnings have been humble , we are confident that our dedication and ongoing efforts will result in k - cap becoming a world - renowned longitudinal observation database , along with capsure and j - cap .
this article announces the development and establishment of k - cap as the first database for comprehensive data collection about prostate cancer patients in korea for the purposes of research and improved patient care .
this study tested the web - based system of the k - cap database to analyze coded excel files from three institutions .
the system operated precisely , and the pilot test verified that the web - based database system is suitable for k - cap .
the system processes will run successfully as long as sufficient and updated data is continuously provided to the system manager .
as soon as possible , complete statistical results of registered prostate cancer patients will be reported for basic background data .
 purposethe purpose of this article was to announce the establishment of the multicenter korean prostate cancer database ( k - cap ) and to provide urologists with details about k - cap 's methodology.materials and methodsthe initial participating k - cap institutions include five medical centers in korea . 
 first , we registered prostate cancer patients who underwent radical prostatectomy as the basic background data . 
 k - cap is poised to combine these initial observational longitudinal studies with those of other eligible institutions as the database grows . 
 all current prostate cancer patients in korea are able to be registered into the web - based database system and thereby have a role in several observational studies . 
 the structure of the database for k - cap was developed by matching it with the respective data from different studies . 
 the operability of the k - cap database system was verified by using the existing databases from three participating institutions.resultsthe analysis of clinicopathologic characteristics of patients with the use of the web - based database was successfully conducted . 
 we confirmed the accurate operation of the web - based database system without any difficulties.conclusionswe are announcing the establishment of k - cap the first database of comprehensive observational longitudinal studies about prostate cancer in korea . 
 the database will be successfully maintained by sufficiently and continuously updating all patient data covering several treatments . 
 complete statistical results for registered prostate cancer patients are forthcoming for the basic background data to establish the database . even though much trial and error are expected during the development process 
 , we expect that k - cap will eventually become one of the most powerful longitudinal observation databases . 
INTRODUCTION
MATERIALS AND METHODS
1. Organization of K-CaP
1) Participating institutions (in alphabetical order)
2) Eligible institutions
2. Data collection, entry, follow-up, and retrieval
1) Data collection
2) Entry
3) Follow-up
4) Data retrieval
5) Quality control
3. The e-CRF system for K-CaP
RESULTS
DISCUSSION
CONCLUSIONS
SUPPLEMENTARY MATERIALS