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Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration
RECRUITINGSponsored by AstraZeneca
Actively Recruiting
SponsorAstraZeneca
Started2025-06-30
Est. completion2028-06-30
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07052578
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
Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria: 1. Male patients aged ≥ 18 years old; 2. Signed ICF, including consent for blood samples ctDNA and ctDNA-based HRRm testing; 3. Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages); 4. High-aggressive disease (Gleason 8-10); 5. 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); 6. Availability of source medical documentation; 7. Known HRRm status based on tumour sample evaluation performed in routine practice. Exclusion Criteria: 1. Participation in any interventional trial since the mPC diagnosis. 2. Progression to mCRPC.
Conditions2
CancerProstate Cancer
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Actively Recruiting
SponsorAstraZeneca
Started2025-06-30
Est. completion2028-06-30
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07052578