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

An observational study of Prostate Cancer, run by AstraZeneca at 28 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

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

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
How many people: 230 participants
Where: 28 sitesRussia
Study dates: 30 Jun 2025to 31 Dec 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Study population: It is planned to enroll approximately 230 patients with high-aggressive (Gleason 8-10) high-volume mHSPC (115 HRRm and 115 HRRwt) with available medical history and known HRRm status in about 30 sites in Russian Federation

Who may be able to join

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 routine tumour sample analysis.

Who cannot join

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

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

City, postcode or hospital

Sites recruiting now only

28 sites in 1 country

Russia28 sites, 22 recruiting

Research Site
Arkhangelsk
Recruiting
Research Site
Barnaul
Recruiting
Research Site
Chelyabinsk
Recruiting
Research Site
Irkutsk
Recruiting
Research Site
Kazan'
Not yet recruiting
Research Site
Krasnodar
Recruiting
Research Site
Krasnoyarsk
Recruiting
Research Site
Moscow
Recruiting
Research Site
Moscow
Not yet recruiting
Research Site
Moscow
Withdrawn
Research Site
Murmansk
Not yet recruiting
Research Site
Nal'chik
Recruiting
Research Site
Nizhny Novgorod
Recruiting
Research Site
Obninsk
Recruiting
Research Site
Omsk
Withdrawn
Research Site
Pskov
Not yet recruiting
Research Site
Saint Petersburg
Not yet recruiting
Research Site
Saint Petersburg
Withdrawn
Research Site
Saransk
Not yet recruiting
Research Site
Sochi
Withdrawn
Research Site
Syktyvkar
Not yet recruiting
Research Site
Tomsk
Withdrawn
Research Site
Tomsk
Recruiting
Research Site
Tver'
Withdrawn
Research Site
Tyumen
Recruiting
Research Site
Ufa
Recruiting
Research Site
Velikiy Novgorod
Not yet recruiting
Research Site
Yekaterinburg
Recruiting

Other trials in Russia

About this study

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

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

Read the detailed description

This is a multicentre observational study on treatment approaches, demographic and clinical characteristics and on HRRm evaluation in ctDNA in patients with high-aggressive high-volume mHSPC with known tumor HRRm status in Russian Federation. The study will sequentially include only those patients who have signed the informed consent form (ICF). No procedures will be applied to patients in addition to the routine clinical practice.

Enrollment is intended to ensure sufficient representation of both HRRm and HRRwt populations for subgroup analyses. Therefore, the enrolled cohort should not be interpreted as representative of the true prevalence of HRRm in the Russian mHSPC population. Study population will consist of patients with high-aggressive (Gleason 8-10) high-volume mHSPC with available medical history and known tumor HRRm status, which has been determined from a tumour sample obtained from the patient as part of routine practice. It is estimated that approximately 230 patients will be enrolled in about 30 sites. In this case, the ratio of patients with HRR gene mutations (HRRm) to patients with wild-type HRR genes (HRRwt) will be approximately 1:1 (115 HRRm and 115 HRRwt), so that both populations are represented in the study sample, including patients without mutations.

The study will include two visits carried out according to routine clinical practice. At baseline visit (visit 1) demographic and clinical characteristics and treatment approaches from the date of high-aggressive high-volume mPC diagnosis (date of first metastases verification) till enrollment will be collected based on the patient's medical records. In case of absence of data required to be collected by the protocol, additional data may be obtained during patient's interview directly and recorded in the source documents related to the visit. For ctDNA and ctDNA-based HRRm testing (by NGS) routinely collected blood samples will be used. Testing will be performed in central laboratories.

Visit 2 (final visit) will be conducted at the time of disease progression or after 12 (±3) months (whichever occurs first) to collect follow-up data on progression to mCRPC and subsequent treatment, if applicable. If the patient is unable to visit the study site (e.g. in case the patient is being treated and observed at the place of residence) the data collection of visits 2 could be carried out via telephone contact.

All study data will be entered into electronic case report form (eCRF). The study physician will be responsible for ensuring that all required data is collected and entered into the eCRF.

Overall expected duration of the study (from the first patient inclusion to the final database lock) is about 36 months, or until 230 eligible patients are included to the study and data on these patients are collected (including follow-up data), whichever occurs first.

Conditions: Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients received any ADT
Proportion of patients received any Androgen deprivation therapy
Measured: 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
Measured: 36 months
Proportion of patients received first generation antiandrogens
Proportion of patients received first generation antiandrogens
Measured: 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;
Measured: 36 months
Duration of ARPI therapy
Duration (months) of androgen receptor pathway inhibitors (ARPI) therapy
Measured: 36 months
Proportion of patients received any chemotherapy at mHSPC
Proportion of patients received any chemotherapy at metastatic hormone-sensitive prostate cancer
Measured: 36 months
Duration of chemotherapy
Duration (months) of chemotherapy, No. of cycles of chemotherapy;
Measured: 36 months
Proportion of patients received radiation therapy
Proportion of patients received radiation therapy (RT) overall and by each type (if applicable);
Measured: 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);
Measured: 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);
Measured: 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;
Measured: 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);
Measured: 36 months
Proportion of patients with each site of disease progression
Proportion of patients with each site of disease progression (metastases);
Measured: 36 months
Testosterone level at the time of mCRPC
Testosterone level (nmol/l) at the time of castrate-resistant disease (mCRPC diagnosis);
Measured: 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.
Measured: 36 months

Secondary outcomes (16)

Age at the diagnosis of high-aggressive high-volume mPC
Age at the diagnosis of high-aggressive high-volume Metastatic prostate cancer (mPC)
Measured: 36 months
Proportion of patients of different races and ethnicities
Proportion of patients of different races and ethnicities overall and in subgroups HRRm/HRRwt;
Measured: 36 months
Proportion of patients with presence of a family oncology history
Proportion of patients with presence of a family oncology history (first degree relatives) overall and by each disease, in the total sample and in subgroups HRRm/HRRwt;
Measured: 36 months
Proportion of patients with a personal oncology history
Proportion of patients with a personal oncology history overall and by each disease, in the total sample and in subgroups HRRm/HRRwt;
Measured: 36 months
Proportion of patients with each category by ECOG assessmen
Proportion of patients with each category by Eastern Cooperative Oncology Group (ECOG) assessment at the inclusion;
Measured: 36 months
Proportion of patients with each type of mPC diagnosi
Proportion of patients with each type of Metastatic prostate cancer (mPC) diagnosis (de novo, metachronous);
Measured: 36 months
Proportion of patients with each stage by TNM classification
Proportion of patients with each stage by TNM classification;
Measured: 36 months
Proportion of patients with each histological type of tumor
Proportion of patients with each histological type of tumor (types of adenocarcinoma);
Measured: 36 months
Proportion of patients with each category by Gleason scale
Proportion of patients with each category (8 (4+4), 8 (3+5), 8 (5+3), 9, 10)) by Gleason scale, in the total sample and in subgroups (de novo and in metachronous mPC, HRRm/HRRwt, ctDNA+/ctDNA-);
Measured: 36 months
Time from initial diagnosis to mPC diagnosis
Time from initial diagnosis to mPC diagnosis (calculated for patients with metachronous disease, as a time period between the date of initial diagnosis of PC and the date of confirmed metastatic disease diagnosis);
Measured: 36 months
Proportion of patients with each localization of metastases at the diagnosis of mPC
Proportion of patients with each localization of metastases at the diagnosis of mPC (confirmed metastatic disease), symptomatic or not;
Measured: 36 months
PSA level at the diagnosis of mPC
PSA level at the diagnosis of mPC (confirmed metastatic disease);
Measured: 36 months
Proportion of patients with each HRR mutation among all HRRm patient
Proportion of patients with each HRR mutation among all HRRm patients, in the total sample and in subgroups (de novo and in metachronous mPC, ctDNA+/ctDNA-);
Measured: 36 months
Proportion of patients with each source of tumor sample
Proportion of patients with each source of tumor sample (primary tumor, metastases), which was used for the HRRm status determination in routine practice;
Measured: 36 months
Proportion of patients with presence of ctDNA
Proportion of patients with presence of ctDNA, in the total sample and in subgroups (de novo and in metachronous mPC, HRRm/HRRwt);
Measured: 36 months
ctDNA HRRm/HRRwt and tumor HRRm/HRRwt coincidence rate
ctDNA HRRm/HRRwt and tumor HRRm/HRRwt coincidence rate.
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202531 Dec 2027

First posted4 Jul 2025
Study start30 Jun 2025
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 230 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07052578
Sponsor's protocol ID: D133HR00059
Acronym: CONCORD
Status last verified: Oct 2026
First submitted: 26 Jun 2025
Last updated: 22 Oct 2026
Results posted: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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