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

NCT07052578 | Recruiting

• 1 other identifier: D133HR00059
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 18

Brief Summary

A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (15)

• Proportion of patients received any ADT

  Proportion of patients received any Androgen deprivation therapy

  36 months

• Proportion of patients received ADT by each type and by each drug

  Proportion of patients received Androgen deprivation therapy by each type and by each drug

  36 months

• Proportion of patients received first generation antiandrogens

  Proportion of patients received first generation antiandrogens

  36 months

• Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC

  Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC overall and by each drug;

  36 months

• Duration of ARPI therapy

  Duration (months) of androgen receptor pathway inhibitors (ARPI) therapy

  36 months

• Proportion of patients received any chemotherapy at mHSPC

  Proportion of patients received any chemotherapy at metastatic hormone-sensitive prostate cancer

  36 months

• Duration of chemotherapy

  Duration (months) of chemotherapy, No. of cycles of chemotherapy;

  36 months

• Proportion of patients received radiation therapy

  Proportion of patients received radiation therapy (RT) overall and by each type (if applicable);

  36 months

• Proportion of patients with each radiation area

  Proportion of patients with each radiation area (if applicable) (to be calculated in patients who received any RT);

  36 months

• Proportion of patients underwent surgery at mHSPC

  Proportion of patients underwent surgery at Metastatic hormone-sensitive prostate cancer stage overall and by each type (if applicable);

  36 months

• Proportion of patients received triplet therapy at mHSPC

  Proportion of patients received triplet therapy (ADT + ARPI + chemotherapy) at Metastatic hormone-sensitive prostate cancer overall and by each ARPI;

  36 months

• Time from mPC diagnosis to progression to mCRPC

  Time from Metastatic prostate cancer diagnosis to progression to Metastatic castration-resistant prostate cancer (mCRPC) (calculated between the date of confirmed metastatic disease diagnosis and the date of progression to mCRPC) in the total sample and in different subgroups (HRRm/HRRwt, ctDNA+/ctDNA-, different therapeutical approaches);

  36 months

• Proportion of patients with each site of disease progression

  Proportion of patients with each site of disease progression (metastases);

  36 months

• Testosterone level at the time of mCRPC

  Testosterone level (nmol/l) at the time of castrate-resistant disease (mCRPC diagnosis);

  36 months

• Proportion of patients with presence of pathogenic mutations in HRR genes in ctDNA

  Proportion of patients with presence of pathogenic mutations in Homologous recombination repair (HRR) genes detected in culating tumor DNA (ctDNA) by Next Generation Sequencing (NGS) overall and by each gene.

  36 months

Secondary Outcomes (16)

• Age at the diagnosis of high-aggressive high-volume mPC

  36 months

• Proportion of patients of different races and ethnicities

  36 months

• Proportion of patients with presence of a family oncology history

  36 months

• Proportion of patients with a personal oncology history

  36 months

• Proportion of patients with each category by ECOG assessmen

  36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

It is planned to enroll approximately 400 patients with high-aggressive (Gleason 8-10) high-volume mHSPC (250 HRRm and 150 HRRwt) with available medical history and known HRRm status in about 30 sites in Russian Federation.

You may qualify if:

• Male patients aged ≥ 18 years old;
• Signed ICF, including consent for blood samples ctDNA and ctDNA-based HRRm testing;
• Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages);
• High-aggressive disease (Gleason 8-10);
• 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);
• Availability of source medical documentation;
• Known HRRm status based on tumour sample evaluation performed in routine practice.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (18)

Research Site

Arkhangelsk, Russia

RECRUITING

Research Site

Barnaul, Russia

RECRUITING

Research Site

Chelyabinsk, Russia

RECRUITING

Research Site

Irkutsk, Russia

NOT YET RECRUITING

Research Site

Krasnodar, Russia

NOT YET RECRUITING

Research Site

Krasnoyarsk, Russia

NOT YET RECRUITING

Research Site

Moscow, Russia

NOT YET RECRUITING

Research Site

Moscow, Russia

RECRUITING

Research Site

Nal'chik, Russia

NOT YET RECRUITING

Research Site

Nizhny Novgorod, Russia

NOT YET RECRUITING

Research Site

Obninsk, Russia

RECRUITING

Research Site

Omsk, Russia

NOT YET RECRUITING

Research Site

Saint Petersburg, Russia

NOT YET RECRUITING

Research Site

Saransk, Russia

NOT YET RECRUITING

Research Site

Tomsk, Russia

NOT YET RECRUITING

Research Site

Tyumen, Russia

RECRUITING

Research Site

Ufa, Russia

RECRUITING

Research Site

Yekaterinburg, Russia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

RU (18)