RECRUITINGOBSERVATIONAL
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
About This Trial
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
1. Participation in any interventional trial since the mPC diagnosis.
2. Progression to mCRPC.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 (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