The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer. This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery. The infrastructure is also designed to enable future cohort multiple randomized controlled trials.
Study Type
OBSERVATIONAL
Enrollment
700
Radboud University Medical Center
Nijmegen, Netherlands
RECRUITINGTreatment patterns
Documentation of initial and sequential treatment strategies, including type, timing, and combination of androgen deprivation therapy, androgen receptor pathway inhibitors, chemotherapy, and radiotherapy, within 4 months and beyond 4 months after diagnosis.
Time frame: From diagnosis through study completion, up to 4 years
PSA response
Proportion of patients achieving \>50% and \>90% PSA decline from baseline within the first year after treatment initiation.
Time frame: From treatment initiation up to 12 months.
PSA nadir
Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.
Time frame: From treatment initiation up to 12 months
Utilization of imaging modalities for primary staging
Type and frequency of imaging modalities used at primary staging, including PSMA PET/CT, conventional CT, bone scintigraphy, and MRI.
Time frame: At baseline
Time to clinical progression
Time from treatment initiation to clinical progression, defined as local progression, and/or symptomatic skeletal events (pain, fracture, spinal cord compression), or initiation of surgery or radiotherapy for progression.
Time frame: From treatment initiation through study completion, up to 4 years
Time to biochemical progression
Time from treatment initiation to biochemical progression per PCWG3 criteria, defined as a minimum PSA rise of 25% AND an absolute increase of 2ng/mL from the nadir, confirmed on two measurements ≥3 weeks apart.
Time frame: From treatment initiation through study completion, up to 4 years
Time to radiographic progression
Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET/CT), or RECIST 1.1 criteria.
Time frame: From treatment initiation through study completion, up to 4 years
Time to castration-resistant prostate cancer (CRPC)
Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.
Time frame: From treatment initiation through study completion, up to 4 years
Overall survival
Time from diagnosis to death from any cause.
Time frame: From diagnosis through study completion, up to 4 years
Adverse events
Type, grade, and treatment-relatedness of adverse events occurring during treatment, graded according to the Common Terminology Criteria for Adverse Events version 5.0.
Time frame: From treatment initiation through study completion, up to 4 years
Number of hospital admissions
Total number of planned and unplanned hospital admissions.
Time frame: From treatment initiation through study completion, up to 4 years
Number of outpatient visits
Total number of outpatient visits
Time frame: From treatment initiation through study completion, up to 4 years
Dynamic change in ctDNA fraction
Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment.
Time frame: Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.
Prevalence and clinical phenotypes of genomic alterations
Prevalence and clinical phenotype associations of somatic alterations in prostate cancer related genes and (likely) pathogenic germline variants, detected by cfDNA or tumor tissue.
Time frame: At diagnosis or at disease progression, up to 4 years
Health-Related Quality of Life (Global Health Status)
Clinically meaningful change in Global Health Status using the EORTC QLQ-C30 as a measure for Health Related Quality of Life, from baseline to sequential follow-up.
Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Health-Related Quality of Life (Health Utility)
Change in health utility index and EQ Visual Analogue Scale score measured using the EQ-5D-5L, across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months
Pain intensity and interference
Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF).
Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Fatigue severity and interference
Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI).
Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Prostate cancer-specific symptoms
Change in prostate cancer-specific symptoms measured using the EORTC QLQ-PR25, domain scores for urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning.
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Time frame: Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.