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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAstraZeneca

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Proportion of patients received any ADT

Proportion of patients received any Androgen deprivation therapy

Time frame
36 months
2

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

Time frame
36 months
3

Proportion of patients received first generation antiandrogens

Proportion of patients received first generation antiandrogens

Time frame
36 months
4

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;

Time frame
36 months

Secondary outcomes

1

Age at the diagnosis of high-aggressive high-volume mPC

Age at the diagnosis of high-aggressive high-volume Metastatic prostate cancer (mPC)

Time frame
36 months
2

Proportion of patients of different races and ethnicities

Proportion of patients of different races and ethnicities overall and in subgroups HRRm/HRRwt;

Time frame
36 months
3

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;

Time frame
36 months
4

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;

Time frame
36 months

Other outcomes

Sponsors and contacts

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