RecruitingNot Applicable

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

Russia400 participantsStarted 2025-06-30

Plain-language summary

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 participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of patients received any ADT

Timeframe: 36 months

Proportion of patients received ADT by each type and by each drug

Timeframe: 36 months

Proportion of patients received first generation antiandrogens

Timeframe: 36 months

Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC

Timeframe: 36 months

Duration of ARPI therapy

Timeframe: 36 months

Proportion of patients received any chemotherapy at mHSPC

Timeframe: 36 months

Duration of chemotherapy

Timeframe: 36 months

Proportion of patients received radiation therapy

Trial details

NCT IDNCT07052578

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-11-30

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Proportion of patients received any ADT

Timeframe: 36 months

Proportion of patients received ADT by each type and by each drug

Timeframe: 36 months

Proportion of patients received first generation antiandrogens

Timeframe: 36 months

Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC

Timeframe: 36 months

Duration of ARPI therapy

Timeframe: 36 months

Proportion of patients received any chemotherapy at mHSPC

Timeframe: 36 months

Duration of chemotherapy

Timeframe: 36 months

Proportion of patients received radiation therapy