RecruitingNCT07052578
Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration
A Multicentre Observational Study on Treatment Patterns and ctDNA HRR Evaluation in Aggressive High-volume Metastatic Hormone-sensitive Prostate Cancer in Russian Federation
Sponsor
AstraZeneca
Enrollment
400 participants
Start Date
Jun 30, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria7
- Male patients aged ≥ 18 years old;
- Signed ICF, including consent for blood samples ctDNA and ctDNA-based HRRm testing;
- Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages);
- High-aggressive disease (Gleason 8-10);
- High-volume disease (according to CHAARTED trial criteria: presence of 4 and more (≥4) bone metastases (including at least one (≥1) outside the vertebral column/pelvis) and/or 1 and more (≥1) visceral metastasis);
- Availability of source medical documentation;
- Known HRRm status based on tumour sample evaluation performed in routine practice.
Exclusion Criteria2
- Participation in any interventional trial since the mPC diagnosis.
- Progression to mCRPC.
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT07052578
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