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 range18 Years

SexMALE

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

Timeframe: 36 months

Trial details

NCT IDNCT07052578

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-06-30

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 range18 Years

SexMALE

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

Timeframe: 36 months