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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Participation in any interventional trial since the mPC diagnosis.
Progression to mCRPC.
Trial population
It is planned to enroll approximately 400 patients with high-aggressive (Gleason 8-10) high-volume mHSPC (250 HRRm and 150 HRRwt) with available medical history and known HRRm status in about 30 sites in Russian Federation.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of patients received any ADT
Proportion of patients received any Androgen deprivation therapy
Proportion of patients received ADT by each type and by each drug
Proportion of patients received Androgen deprivation therapy by each type and by each drug
Proportion of patients received first generation antiandrogens
Proportion of patients received first generation antiandrogens
Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC
Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC overall and by each drug;
Secondary outcomes
Age at the diagnosis of high-aggressive high-volume mPC
Age at the diagnosis of high-aggressive high-volume Metastatic prostate cancer (mPC)
Proportion of patients of different races and ethnicities
Proportion of patients of different races and ethnicities overall and in subgroups HRRm/HRRwt;
Proportion of patients with presence of a family oncology history
Proportion of patients with presence of a family oncology history (first degree relatives) overall and by each disease, in the total sample and in subgroups HRRm/HRRwt;
Proportion of patients with a personal oncology history
Proportion of patients with a personal oncology history overall and by each disease, in the total sample and in subgroups HRRm/HRRwt;
Sponsors and contacts
Click on the lead sponsor to view all of their trials.