Table 1.

Domains and 5 example input data elements of the clinical database of prostate cancer, and derived data elements by the prostateredcap R package.

Input data elements for clinical database				Derived analytical dataset
Data element	Type	Source hierarchy	Instructions	Data element	Type	Source
Baseline form: Patient and tumor characteristics at initial diagnosis
Date of birth	Text1	Automated pull from medical record	Answer Format: MM/DD/YYYY	(removed)
Date of initial diagnosis	Text1	1. Initial consultation note: MD-reported date of first biopsy showing prostate cancer 2. Initial consultation note: other MD-reported date of assumed diagnosis of prostate cancer, if treatment started outside without initial biopsy	Answer Format: MM/DD/YYYY ○ Enter the date to the greatest level of granularity available. Use format “MM/YYYY” for month/year only and format “YYYY” for year only. ○ Flag for resolution if unable to find any approximate date.	Age at diagnosis (age_dx)	Continuous value; rounded to 0.1 years	Interval between date of birth and date of initial diagnosis
Clinical N stage (regional lymph node metastases)	Categorical: 0 / 1 / X	1. Initial Consultation note. 2. First GU Oncology follow-up note, particularly if the Initial Consultation note mentioned that outside records were incomplete at that time.	○ Enter ‘X’ if unknown. ○ If N stage at diagnosis is mentioned, but it is not documented if this is clinical or path staging, enter as clinical N stage at diagnosis. ○ If note only describes names of positive lymph nodes, code as N1 for these regional lymph node stations: pelvic, hypogastric, obturator, internal iliac, external iliac, sacral. Code as M1a for all other positive lymph nodes (including common iliac).	Clinical N stage (clin_n)	Binary: TRUE/ FALSE; can be missing	Clinical N stage
Other data elements: patient ID, race, ethnicity, smoking status at diagnosis, date of initial prostate biopsy, sum Gleason at diagnosis (biopsy), primary Gleason pattern at diagnosis, secondary Gleason pattern at diagnosis, histology at diagnosis, PSA at diagnosis, clinical T stage, clinical M stage, primary therapy, sum Gleason at prostatectomy, primary Gleason pattern at prostatectomy, secondary Gleason pattern at prostatectomy, pathologic T stage, pathologic N stage
Sample form: Characteristics of the genomically profiled sample
Sample tissue	Categorical: Prostate / Lymph node / Bone / Lung / Liver / Other soft tissue	Tumor sequencing report	○ “Other soft tissue” only applies to distant metastases, not to local extension of the prostate tumor. ○ If unable to decide, flag for resolution.	Sample tissue (tissue)	Categorical (same categories)	Sample tissue
Other data elements: patient ID, sample ID, date of collection, histology for sample, sample type, extent of disease at collection, sites of disease, volume of bone metastases at time of collection, continuous ADT
Outcome form: Clinical event data
Metastasis date	Text1	1. Oncology History of Last GU Oncology note. 2. Last Urology or Rad-Onc follow-up note.	Answer Format: MM/DD/YYYY. Enter the date to the greatest level of granularity available. Use format “MM/YYYY” for month/year only and format “YYYY” for year only. Enter the date on which metastases were first detected. If M1 at diagnosis, enter diagnosis date.	(removed)	–	Recoded as duration, e.g., diagnosis to metastasis
Other data elements: patient ID, freeze date, continuous ADT start date, castration resistance status and date, metastasis status, last MD visit date (censor date for castration resistance/metastasis), survival status and date of death/last contact
Treatment form: Lines of oncologic treatment
Data elements: patient ID, treatment name, start date, end date/last known treatment date/ongoing, reason for stop

¹Dates are initially captured as text allow for incomplete but useful entries, such as a date of diagnosis as “03/2015” when the day of the month is unknown.