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Treatment approaches and biomarker prevalence in newly diagnosed high‑grade metastatic hormone‑sensitive prostate cancer in Russia

A Multicentre Observational Study on Treatment Approaches and Biomarkers in de Novo Metastatic Hormone Sensitive Prostate Cancer in Russian Federation

Observational AstraZeneca · NCT07146113

This project will collect treatment histories and tumor biomarker results from men in Russia recently diagnosed with high‑grade metastatic hormone‑sensitive prostate cancer to see which treatments are used and how common PTEN loss, HER2 overexpression, and HRR mutations are.

Quick facts

Study typeObservational
Enrollment400 (estimated)
Ages18 Years and up
SexMale
SponsorAstraZeneca Industry-sponsored
Locations17 sites (Arkhangelsk and 16 other locations)
Trial IDNCT07146113 on ClinicalTrials.gov

What this trial studies

This multicentre observational project will enroll about 400 men at roughly 30 sites across the Russian Federation who have de novo high‑aggressive (Gleason 8–10) metastatic prostate cancer diagnosed within the past two years. Investigators will extract demographic and clinical data from medical records and a single routine clinic visit, and will test existing FFPE biopsy samples for PTEN loss, HER2 expression by IHC, and HRR mutations/HRD status. No procedures beyond standard clinical care will be performed and no study follow‑up is planned. Data will be entered into an electronic case report form to describe real‑world treatment patterns and biomarker prevalence in this population.

Who should consider this trial

Good fit: Men aged 18 or older in Russia with de novo histologically confirmed high‑grade (Gleason 8–10) metastatic hormone‑sensitive prostate cancer diagnosed within the past two years, available FFPE biopsy tissue, and not enrolled in interventional trials.

Not a fit: Patients without available FFPE tumor tissue, those with non‑de novo or lower‑grade disease, or those currently participating in interventional trials are unlikely to be eligible or to gain direct benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help clinicians choose treatments and identify patients who might benefit from biomarker‑directed therapies.

How similar studies have performed: Previous observational studies have reported PTEN loss and HRR alterations in metastatic prostate cancer, but prevalence estimates vary and data specifically from Russian cohorts are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male patients aged ≥ 18 years old;
2. Signed ICF, including consent for FFPE tumor tissue sample testing;
3. De novo histologically confirmed high-aggressive (Gleason 8-10) mPC;
4. Diagnosis of mPC (metastatic prostate cancer) within 2 years prior to inclusion;
5. Availability of source medical documentation;
6. Presence of biopsy FFPE tumor tissue sample, obtained as part of standard clinical practice, which will be used for biomarker testing;
7. Unknown HRRm status.

Exclusion Criteria:

1\. Participation in any interventional trial since the mPC diagnosis.

Where this trial is running

Arkhangelsk and 16 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.