Overview
A multicentre observational study on treatment approaches and biomarkers in de novo metastatic hormone sensitive prostate cancer in Russian Federation
Description
This is a multicentre observational study on treatment approaches, demographic and clinical characteristics and prevalence of biomarkers (PTEN-loss, HER2-positive status; HRR mutations, HRD-positive status) in patients with de novo high-aggressive mHSPC in Russian Federation. The study will sequentially include only those patients who have signed the informed consent form (ICF). No procedures will be applied to patients in addition to the routine clinical practice.
Study population will consist of patients with de novo high-aggressive (Gleason 8-10) histologically confirmed mPC diagnosed within 2 years prior to inclusion with available medical history, biopsy formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. It is estimated that approximately 400 patients will be enrolled in about 30 sites.
Demographic and clinical characteristics, treatment approaches and outcomes will be collected during a single visit carried out according to routine clinical practice. Data from the date of de novo high-aggressive mPC diagnosis (date of histological verification) till enrollment will be collected by study physician based on the patient's medical records and interview during the visit and entered into electronic case report form (eCRF). The study physician will be responsible for ensuring that all required data is collected and entered into the eCRF. No follow-up is planned for patients in this study.
For PTEN-loss and HER2-hyperexpression testing (by IHC) and HRRm (mutations in HRR pathway genes), HRD testing (by NGS [next generation sequencing]) available FFPE tumour tissue sample collected as part of routine clinical practice will be used. Testing will be performed in central laboratories.
Overall expected duration of the study enrollment and data collection (from the first patient inclusion to the final database lock) is about 27 months, or until 400 eligible patients are included to the study and data on these patients are collected (including results of FFPE sample testing), whichever occurs first.
Eligibility
Inclusion Criteria:
- Male patients aged ≥ 18 years old;
- Signed ICF, including consent for FFPE tumor tissue sample testing;
- De novo histologically confirmed high-aggressive (Gleason 8-10) mPC;
- Diagnosis of mPC (metastatic prostate cancer) within 2 years prior to inclusion;
- Availability of source medical documentation;
- Presence of biopsy FFPE tumor tissue sample, obtained as part of standard clinical practice, which will be used for biomarker testing;
- Unknown HRRm status.
Exclusion Criteria:
- Participation in any interventional trial since the mPC diagnosis.