An observational study in Prostate Cancer, sponsored by AstraZeneca. Recruiting at 28 sites in Russia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by AstraZeneca · Observational
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 230 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 22, 2026. See what changed
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proportion of patients received any ADT
Proportion of patients received any Androgen deprivation therapy
Time frame: 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
Time frame: 36 months
Proportion of patients received first generation antiandrogens
Proportion of patients received first generation antiandrogens
Time frame: 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;
Time frame: 36 months
Duration of ARPI therapy
Duration (months) of androgen receptor pathway inhibitors (ARPI) therapy
Time frame: 36 months
Proportion of patients received any chemotherapy at mHSPC
Proportion of patients received any chemotherapy at metastatic hormone-sensitive prostate cancer
Time frame: 36 months
Duration of chemotherapy
Duration (months) of chemotherapy, No. of cycles of chemotherapy;
Time frame: 36 months
Proportion of patients received radiation therapy
Proportion of patients received radiation therapy (RT) overall and by each type (if applicable);
Time frame: 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);
Time frame: 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);
Time frame: 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;
Time frame: 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);
Time frame: 36 months
Proportion of patients with each site of disease progression
Proportion of patients with each site of disease progression (metastases);
Time frame: 36 months
Testosterone level at the time of mCRPC
Testosterone level (nmol/l) at the time of castrate-resistant disease (mCRPC diagnosis);
Time frame: 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.
Time frame: 36 months
Age at the diagnosis of high-aggressive high-volume mPC
Age at the diagnosis of high-aggressive high-volume Metastatic prostate cancer (mPC)
Time frame: 36 months
Proportion of patients of different races and ethnicities
Proportion of patients of different races and ethnicities overall and in subgroups HRRm/HRRwt;
Time frame: 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;
Time frame: 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;
Time frame: 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;
Time frame: 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);
Time frame: 36 months
Proportion of patients with each stage by TNM classification
Proportion of patients with each stage by TNM classification;
Time frame: 36 months
Proportion of patients with each histological type of tumor
Proportion of patients with each histological type of tumor (types of adenocarcinoma);
Time frame: 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-);
Time frame: 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);
Time frame: 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;
Time frame: 36 months
PSA level at the diagnosis of mPC
PSA level at the diagnosis of mPC (confirmed metastatic disease);
Time frame: 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-);
Time frame: 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;
Time frame: 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);
Time frame: 36 months
ctDNA HRRm/HRRwt and tumor HRRm/HRRwt coincidence rate
ctDNA HRRm/HRRwt and tumor HRRm/HRRwt coincidence rate.
Time frame: 36 months
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Plan to share: 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
Supporting information: Clinical study report
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2027, 30 months after the start.
Of 109 industry-sponsored observational studies under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's planned 30 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Nov 2028 → Dec 2027 and completion Nov 2028 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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