Status:
RECRUITING
Treatment Approaches and Biomarkers PRevalence In de Novo MEtastatic Hormone-sensitive Prostate Cancer in Russian Federation
Lead Sponsor:
AstraZeneca
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
A multicentre observational study on treatment approaches and biomarkers in de novo metastatic hormone sensitive prostate cancer in Russian Federation
Detailed 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 s...
Eligibility Criteria
Inclusion
- 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
- 1\. Participation in any interventional trial since the mPC diagnosis.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07146113
Start Date
June 30 2025
End Date
June 30 2027
Last Update
December 23 2025
Active Locations (17)
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1
Research Site
Arkhangelsk, Russia
2
Research Site
Barnaul, Russia
3
Research Site
Chelyabinsk, Russia
4
Research Site
Irkutsk, Russia