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Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration

NCT07052578

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Prostate Cancer

Countries: Russia

A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (26)

Arkhangelsk, Russia
Barnaul, Russia
Chelyabinsk, Russia
Irkutsk, Russia
Kazan', Russia
Krasnodar, Russia
Krasnoyarsk, Russia
Moscow, Russia
Moscow, Russia
Moscow, Russia
Nal'chik, Russia
Nizhny Novgorod, Russia
Obninsk, Russia
Omsk, Russia
Pskov, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Saransk, Russia
Sochi, Russia
Syktyvkar, Russia
Tomsk, Russia
Tomsk, Russia
Tver', Russia
Tyumen, Russia
Ufa, Russia
Yekaterinburg, Russia