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

Launched by ASTRAZENECA · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how doctors in Russia currently treat men with a specific type of aggressive prostate cancer that has spread to other parts of the body but still responds to hormone therapy. The study also looks at certain genetic markers found in the blood that can help understand the cancer better. This information may help improve future treatment decisions for patients with this high-risk form of prostate cancer.

Men who are 18 years or older with this type of prostate cancer that is both aggressive and has spread to multiple bones or organs might be eligible to join. Participants need to agree to give blood samples for genetic testing and have medical records available for review. This study does not involve any new treatments but observes existing care patterns and tests. It is important to know that men currently in other treatment trials or whose cancer has become resistant to hormone therapy are not eligible. If you join, you can expect to provide information and blood samples, helping researchers learn more about this serious form of prostate cancer.

Gender

MALE

Eligibility criteria

• 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.