High Risk Localized Prostate Cancer, Synchronous Metastatic Hormone-Sensitive Prostate Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Inclusion criteria
* Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA \> 20 ng/mL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET/CT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin. * Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate * Age ≥ 18 years at the time of inclusion. * Written informed consent * Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.
Exclusion criteria
* Not currently living in the Netherlands.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment patterns | From diagnosis through study completion, up to 4 years | 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. |
| PSA response | From treatment initiation up to 12 months. | Proportion of patients achieving \>50% and \>90% PSA decline from baseline within the first year after treatment initiation. |
| PSA nadir | From treatment initiation up to 12 months | Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir. |
| Utilization of imaging modalities for primary staging | At baseline | Type and frequency of imaging modalities used at primary staging, including PSMA PET/CT, conventional CT, bone scintigraphy, and MRI. |
| Time to clinical progression | From treatment initiation through study completion, up to 4 years | 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 to biochemical progression | From treatment initiation through study completion, up to 4 years | 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 to radiographic progression | From treatment initiation through study completion, up to 4 years | Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET/CT), or RECIST 1.1 criteria. |
| Time to castration-resistant prostate cancer (CRPC) | From treatment initiation through study completion, up to 4 years | Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria. |
| Overall survival | From diagnosis through study completion, up to 4 years | Time from diagnosis to death from any cause. |
| Adverse events | From treatment initiation through study completion, up to 4 years | Type, grade, and treatment-relatedness of adverse events occurring during treatment, graded according to the Common Terminology Criteria for Adverse Events version 5.0. |
| Number of hospital admissions | From treatment initiation through study completion, up to 4 years | Total number of planned and unplanned hospital admissions. |
| Number of outpatient visits | From treatment initiation through study completion, up to 4 years | Total number of outpatient visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic change in ctDNA fraction | Change from baseline at 4-6 weeks, and 9 months after start of initial treatment. | Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment. |
| Prevalence and clinical phenotypes of genomic alterations | At diagnosis or at disease progression, up to 4 years | Prevalence and clinical phenotype associations of somatic alterations in prostate cancer related genes and (likely) pathogenic germline variants, detected by cfDNA or tumor tissue. |
| Health-Related Quality of Life (Global Health Status) | Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months. | 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. |
| Health-Related Quality of Life (Health Utility) | Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months | 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. |
| Pain intensity and interference | Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months. | Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF). |
| Fatigue severity and interference | Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months. | Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI). |
| Prostate cancer-specific symptoms | Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months. | 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. |
Countries
Netherlands
Contacts
CONTACTNiven Mehra, PhD
Outcome results
None listed