Treatment choices and blood HRR gene testing in aggressive, high-volume metastatic hormone-sensitive prostate cancer in Russia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study will enroll about 400 men with high-aggressive (Gleason 8-10), high-volume metastatic hormone-sensitive prostate cancer who already have known tumor HRR mutation status. Investigators will collect demographic, clinical and treatment-history data from medical records and obtain consented blood samples for ctDNA-based HRR testing, with no procedures beyond routine care. Enrollment is sequential at roughly 30 sites across the Russian Federation and the protocol includes two visits aligned with routine clinical practice. The goal is to characterize real-world treatment patterns and the frequency and concordance of HRR mutations in ctDNA versus prior tumor testing in this population.

Why it matters

Who can join: the full rules

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 routine tumour sample analysis.

Exclusion Criteria:

1. Participation in any interventional trial since the mPC diagnosis.
2. Progression to mCRPC.

Where it's running

• Research Site
  Arkhangelsk, Russia Recruiting
• Research Site
  Barnaul, Russia Recruiting
• Research Site
  Chelyabinsk, Russia Recruiting
• Research Site
  Irkutsk, Russia Recruiting
• Research Site
  Krasnodar, Russia Recruiting
• Research Site
  Krasnoyarsk, Russia Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.