Home › Trials › NCT07052578

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

A Multicentre Observational Study on Treatment Patterns and ctDNA HRR Evaluation in Aggressive High-volume Metastatic Hormone-sensitive Prostate Cancer in Russian Federation

Observational AstraZeneca · NCT07052578

See how treatment choices and blood-based HRR gene testing appear in men with aggressive, high-volume metastatic hormone-sensitive prostate cancer in the Russian Federation.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages18 Years and up
SexMale
SponsorAstraZeneca Industry-sponsored
Locations18 sites (Arkhangelsk and 17 other locations)
Trial IDNCT07052578 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Men aged 18 or older in the Russian Federation with high-aggressive (Gleason 8-10), high-volume metastatic hormone-sensitive prostate cancer and a known tumor HRR mutation status who can provide informed consent are ideal candidates.

Not a fit: Men who are already in interventional trials, have progressed to castration-resistant disease, or do not have documented tumor HRR status are unlikely to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, the study could help inform how blood-based HRR testing and current treatment choices relate in this high-risk group, guiding future care and research.

How similar studies have performed: Blood-based ctDNA testing for HRR mutations has shown promise in research settings, but large real-world observational data specifically in aggressive high-volume mHSPC, particularly within Russia, are limited.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Arkhangelsk and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.