Demographic Factors
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical or patient-reported TYPE: Date by DD/MM/YYYY
date
Height and weight are used to calculate BMI INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Numerical value RESPONSE OPTIONS: Numerical value of height in cm or in
float
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Single answer
integer
Height and weight are used to calculate BMI INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Numerical value RESPONSE OPTIONS: Numerical value of weight in kg or lbs
float
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical reported TYPE: Single answer
integer
Baseline Clinical Factors
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: Numerical value of hemoglobin level in g/L
float
Baseline Tumor Factors
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical RESPONSE OPTIONS: Numerical value of PSA ng/mL
float
Pathologic staging preferred, if available cT0: No evidence of primary tumor cT1: if not able to select T1a, T1b or T1c: Clinically inapparent tumor neither palpable nor visible by imaging cT1a: Tumor incidental histologic finding in 5 percent or less of tissue resected cT1b: Tumor incidental histologic finding in more than 5 percent of tissue resected cT1c: Tumor identified by needle biopsy (eg, because of elevated PSA) cT2: if not able to select T2a, T2b or T2c: Tumor confined within prostate* cT2a: Tumor involves one-half of one lobe or less cT2b: Tumor involves more than one-half of one lobe but not both lobes cT2c: Tumor involves both lobes cT3: if not able to select T3a, T3b or T3c: Tumor extends through the prostate capsule cT3a: Extracapsular extension (unilateral or bilateral) cT3b: Tumor invades seminal vesicle(s) cT4: Tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall cTX: Primary tumor cannot be assessed INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
Pathologic staging preferred, if available cNo: regional lymph node metastasis cN1: Metastasis in regional lymph node(s) cNX: Regional lymph nodes were not assessed INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
Pathologic staging preferred, if available pT2: if not able to select T2a, T2b or T2c: Organ confined pT2a: Unilateral, one-half of one side or less pT2b: Unilateral, involving more than one-half of side but not both sides pT2c: Bilateral disease pT3: if not able to select T3a, T3b: Extraprostatic extension pT3a: Extraprostatic extension or microscopic invasion of bladder neck pT3b: Seminal vesicle invasion pT4: Invasion of rectum, levator muscles, and/or pelvic wall pTX: Primary tumor cannot be assessed INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
Pathologic staging preferred, if available pN0: No positive regional nodes pN1: Metastases in regional node(s) pNX: Regional nodes not sampled INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
INCLUSION CRITERIA: All patients, If answered 'yes' on Gleason score (GLEASON) TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: 2-10
integer
INCLUSION CRITERIA: All patients, If answered 'yes' on Gleason score (GLEASON) TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Numerical value RESPONSE OPTIONS: 2-10
integer
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
High burden is indicated as any of the following criteria (from: CHAARTED (randomized clinical trial in the US): - Visceral metastases (extranodal) - Bone metastases with at least 4 bone lesions OR at least 1 bone lesion outside of the vertebral column or pelvis. INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
Treatment Factors
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
INCLUSION CRITERIA: All patients, If answered 'yes' on prior prostatectomy (prostatectx) TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Date by DD/MM/YYYY
date
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
Use of any of the following treatments to induce castrate levels of serum testosterone: 1. LHRH or GnRH agonist or antagonist 2. Bilateral orchiectomies INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
Any medication that treats the prostate cancer taken by mouth, through a vein, or injected, other than ADT INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer
Both anti-resorptive medications or denosumab are relevant INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer
integer