Aggressive Disease Treatment Patterns and CtDNA HRR evaluatiON in High-volume metastatiC hORmone-sensitive Prostate Cancer in Russian FeDeration
Recruiting · NCT07052578 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →What this trial is about
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Participation in any interventional trial since the mPC diagnosis.
- Progression to mCRPC.
Where it is running
26 locations listed.
- Research Site - Arkhangelsk, Russia
- Research Site - Barnaul, Russia
- Research Site - Chelyabinsk, Russia
- Research Site - Irkutsk, Russia
- Research Site - Kazan', Russia
- Research Site - Krasnodar, Russia
- Research Site - Krasnoyarsk, Russia
- Research Site - Moscow, 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 - Pskov, Russia
- Research Site - Saint Petersburg, Russia
- Research Site - Saint Petersburg, Russia
- Research Site - Saransk, Russia
- Research Site - Sochi, Russia
- Research Site - Syktyvkar, Russia
- Research Site - Tomsk, Russia
- Research Site - Tomsk, Russia
- Research Site - Tver', Russia
- Research Site - Tyumen, Russia
- Research Site - Ufa, Russia
- Research Site - Yekaterinburg, Russia