C61
Conditions
Interventions
Group 1: Cohort 1: biochemical recurrence after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof)
For all cohorts during the routine v
Sponsors
UroTrials GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Adult prostate cancer patients (age =18 years). • Diagnosis at time of study inclusion Cohort 1: biochemical recurrence (BCR) after local curative intended treatment (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof) Cohort 2: non-metastatic castration-resistant prostate cancer (nmCRPC) or Cohort 3: metastatic hormone sensitive prostate cancer (mHSPC) or Cohort 4: metastatic castration-resistant prostate cancer (mCRPC) (irrespective of treatment choice, treatment line) • Patients who will receive a new line of systemic therapy at the time of study entry or up to 4 weeks thereafter. Regarding Cohort 4 this includes patients with a new diagnosis of mCRPC (=first line mCRPC) after either treatment for mHSPC or non-metastatic CRPC as well as patients with prior mCRPC treatments (2nd, 3rd, … line). • For Cohorts 1, 2 and 3: Disease proven by clinical measures (i.e. standard imaging) to be either unsuitable for local salvage treatment (e.g. surgery, radiotherapy) or local treatment is declined by the patient. • Patients, who are able and willing to sign the informed consent form
Exclusion criteria
Exclusion criteria: Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe therapy frequencies and patterns of therapy in routine clinical practice for the included patient cohorts | — |
Secondary
| Measure | Time frame |
|---|---|
| • To describe annual (vs. cumulative) patterns of disease management i.e. choice of treatment applied in German routine practice (including initial disease/ metastatic diagnosis and previous cancer drug and non-drug treatments) and • Methodology used and frequency for disease status assessment (e.g. PSA-measurements, imaging) • To assess drug effectiveness depending on prior use of an ARPI, docetaxel and other drugs in the BCR, nmCRPC and mHSPC setting as well as prior treatments for mCRPC • To identify parameters affecting prognosis. • Incidence of adverse events, serious adverse events including long term safety and tolerability • Treatment adherence • To assess patient reported outcomes including quality of life by treatment. • To assess patient paths (place/type of initial and metastatic diagnosis, involved treatment facilities, tumor board decisions) • Applied imaging assessments (PSMA PET/CT, CT, PET/CT, MRI, Bone scan, PSMA-SPECT/CT, etc.) • To describe patient and tumor characteristics (including molecular alterations, if assessed) in routine care of mHSPC and mCRPC patients | — |
Countries
Germany
Contacts
Public ContactMarc-Oliver Grimm
Universitätsklinikum Jena; Klinik und Poliklinik für Urologie
Outcome results
None listed