Treatment Approaches and Biomarkers PRevalence In de Novo MEtastatic Hormone-sensitive Prostate Cancer in Russian Federation

Plain-language summary

This observational study examines treatment approaches and the prevalence of biomarkers in patients with newly diagnosed (de novo) metastatic hormone-sensitive prostate cancer in the Russian Federation. Men aged 18 and older with a histologically confirmed aggressive (Gleason 8-10) metastatic prostate cancer diagnosis may take part. This is a study without a clinical phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

AstraZeneca

Start date

6/30/2025

Estimated completion

6/30/2027

Countries

Russia

Related genes

Locations

• Arkhangelsk, Russia
• Barnaul, Russia
• Chelyabinsk, Russia
• Irkutsk, Russia
• Krasnodar, Russia
• Krasnoyarsk, Russia
• Moscow, Russia
• Moscow, Russia
• Nizhny Novgorod, Russia
• Obninsk, Russia
• Omsk, Russia
• Saint Petersburg, Russia
• Saransk, Russia
• Tomsk, Russia
• Tyumen, Russia
• Ufa, Russia
• Yekaterinburg, Russia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.