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)

Research Site

Arkhangelsk, Russia

Research Site

Barnaul, Russia

Research Site

Chelyabinsk, Russia

Research Site

Irkutsk, Russia

Research Site

Krasnodar, Russia

Research Site

Krasnoyarsk, Russia

Research Site

Moscow, Russia

Research Site

Moscow, Russia

Research Site

Nal'chik, Russia

Research Site

Nizhny Novgorod, Russia

Research Site

Obninsk, Russia

Research Site

Omsk, Russia

Research Site

Saint Petersburg, Russia

Research Site

Saransk, Russia

Research Site

Tomsk, Russia

Research Site

Tyumen, Russia

Research Site

Ufa, Russia

Research Site

Yekaterinburg, Russia

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NCT07052578


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