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Prostate CancerPRIMENCT07146113

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

An observational study of Prostate Cancer, run by AstraZeneca at 16 sites in Russia.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

A multicentre observational study on treatment approaches and biomarkers in de novo 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
400 participants
Where
16 sitesRussia
Study dates
30 Jun 2025to 30 Jun 2027
Phase
Observational
Are there results?
None posted in the registry

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 400 patients with de novo high-aggressive (Gleason 8-10) histologically confirmed mPC diagnosed within 2 years prior to inclusion in about 30 sites in Russian Federation. Patients must have available medical history and biopsy FFPE tumour tissue sample.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Russia16 sites

  • Research Site

    Arkhangelsk

  • Research Site

    Barnaul

  • Research Site

    Chelyabinsk

  • Research Site

    Irkutsk

  • Research Site

    Krasnodar

  • Research Site

    Krasnoyarsk

  • Research Site

    Moscow

  • Research Site

    Nizhny Novgorod

  • Research Site

    Obninsk

  • Research Site

    Omsk

  • Research Site

    Saint Petersburg

  • Research Site

    Saransk

  • Research Site

    Tomsk

  • Research Site

    Tyumen

  • Research Site

    Ufa

  • Research Site

    Yekaterinburg

Other trials in Russia

About this study

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

A multicentre observational study on treatment approaches and biomarkers in de novo 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 prevalence of biomarkers (PTEN-loss, HER2-positive status; HRR mutations, HRD-positive status) in patients with de novo high-aggressive mHSPC 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.

Study population will consist of patients with de novo high-aggressive (Gleason 8-10) histologically confirmed mPC diagnosed within 2 years prior to inclusion with available medical history, biopsy formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. It is estimated that approximately 400 patients will be enrolled in about 30 sites.

Demographic and clinical characteristics, treatment approaches and outcomes will be collected during a single visit carried out according to routine clinical practice. Data from the date of de novo high-aggressive mPC diagnosis (date of histological verification) till enrollment will be collected by study physician based on the patient's medical records and interview during the visit and 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. No follow-up is planned for patients in this study.

For PTEN-loss and HER2-hyperexpression testing (by IHC) and HRRm (mutations in HRR pathway genes), HRD testing (by NGS [next generation sequencing]) available FFPE tumour tissue sample collected as part of routine clinical practice will be used. Testing will be performed in central laboratories.

Overall expected duration of the study enrollment and data collection (from the first patient inclusion to the final database lock) is about 27 months, or until 400 eligible patients are included to the study and data on these patients are collected (including results of FFPE sample testing), 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.

  1. Proportion of patients received any ADT

    Proportion of patients received any Androgen deprivation therapy (ADT)

    Measured: 24 months

  2. Proportion of patients received ADT by each type and by each drug

    Proportion of patients received Androgen deprivation therapy (ADT) by each type and by each drug;

    Measured: 24 months

  3. Proportion of patients received first generation antiandrogens

    Proportion of patients received first generation antiandrogens;

    Measured: 24 months

  4. Proportion of patients received ARPI at mHSPC

    Proportion of patients received androgen receptor pathway inhibitors (ARPI) at Metastatic hormone-sensitive prostate cancer (mHSPC) overall and by each drug;

    Measured: 24 months

  5. Proportion of patients received any chemotherapy at mHSPC

    Proportion of patients received any chemotherapy at Metastatic hormone-sensitive prostate cancer (mHSPC)

    Measured: 24 months

  6. Duration of chemotherapy

    Duration of chemotherapy in months (to be calculated if chemotherapy completed before or at the enrollment);

    Measured: 24 months

  7. Proportion of patients received radiation therapy

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

    Measured: 24 months

  8. 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: 24 months

  9. Proportion of patients underwent surgery at mHSPC stage

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

    Measured: 24 months

  10. Proportion of patients received triplet therapy

    Proportion of patients received triplet therapy (ADT + ARPI + chemotherapy) at mHSPC overall and by each ARPI;

    Measured: 24 months

  11. Proportion of patients with PTEN loss by IHC

    Proportion of patients with PTEN (Phosphatase and TENsin homolog) loss by Immunohistochemistry (IHC)

    Measured: 24 months

  12. Number of Chemotherapy Cycles

    Number of chemotherapy cycles is defined as the total number of chemotherapy cycles completed prior to or at the time of study enrollment.

    Measured: 24 months

Secondary outcomes (14)

  1. Age at the diagnosis of de novo high-aggressive histologically confirmed mPC

    Age at the diagnosis of de novo high-aggressive histologically confirmed mPC, years

    Measured: 24 months

  2. Proportion of patients of different races and ethnicities

    Proportion of patients of different races and ethnicities

    Measured: 24 months

  3. 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;

    Measured: 24 months

  4. Proportion of patients with a personal oncology history

    Proportion of patients with a personal oncology history overall and by each disease;

    Measured: 24 months

  5. Proportion of patients with each category by ECOG assessment

    Proportion of patients with each category by ECOG assessment at the inclusion. ECOG is Eastern Cooperative Oncology Group scale used to assess a patient's functional ability (grades are from 0 to 5 where 0 means "Fully active, able to carry on all pre-disease performance without restriction" and 5 means "Dead")

    Measured: 24 months

  6. Proportion of patients with each stage by TNM classification

    Proportion of patients with each stage by TNM classification. The TNM cancer staging system is a globally recognized method for classifying cancer based on the extent of the tumor (T), involvement of nearby lymph nodes (N), and presence of distant metastasis (M). The TNM values are then grouped into overall stage groupings, usually from I to IV, where Stage I is generally early-stage and Stage IV indicates advanced cancer with distant metastasis.

    Measured: 24 months

  7. Proportion of patients with each histological type of tumour

    Proportion of patients with each histological type of tumour (types of adenocarcinoma);

    Measured: 24 months

  8. 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. The Gleason scale is a system used to grade prostate cancer based on how different the cancer cells look from normal cells under a microscope. It helps doctors determine how quickly the cancer is likely to grow and spread, influencing treatment decisions. The Gleason score is determined by adding the two most common grades (from 1 to 5) found in the biopsy sample

    Measured: 24 months

  9. Proportion of patients with high and low volume of disease

    Proportion of patients with high and low volume of disease;

    Measured: 24 months

  10. Proportion of patients with each localization of metastases

    Proportion of patients with each localization of metastases at the diagnosis, symptomatic or not;

    Measured: 24 months

  11. Proportion of patients with each source of tumour sample

    Proportion of patients with each source of tumour sample (primary tumour, metastases);

    Measured: 24 months

  12. Proportion of patients with each result of HER2 expression by IHC

    Proportion of patients with each result of Human Epidermal Growth Factor Receptor 2 (HER2) expression by Immunohistochemistry (IHC). HER2 Status:

    HER2-positive: Cancer cells have high levels of HER2 protein. HER2-negative: Cancer cells have low or no detectable HER2 protein. HER2-low: This category is emerging, indicating a moderate level of HER2 expression, and may be responsive to certain targeted therapies.

    Measured: 24 months

  13. Proportion of patients with presence of pathogenic mutations in HRR genes

    Proportion of patients with presence of pathogenic mutations in Homologous recombination repair (HRR) genes by Next Generation Sequencing (NGS) results overall and by each gene;

    Measured: 24 months

  14. Proportion of patients with positive HRD status

    Proportion of patients with positive Homologous recombination deficiency (HRD) status by Next Generation Sequencing (NGS) results.

    Measured: 24 months

Timeline

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

  1. First posted28 Aug 2025
  2. Study start30 Jun 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Why it stopped: As a part of planned reassessment for the current period, a decision has been made to prioritize, optimize, and reallocate resources. As a result, enrollment and other study activities have been temporarily halted.

Resources

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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07146113
Sponsor's protocol ID
D133HR00058
Acronym
PRIME
Status last verified
Jun 2026
First submitted
26 Jun 2025
Last updated
26 Jun 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

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by AstraZeneca at 16 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients received any ADT (time frame: 24 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07146113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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PRIME Clinical Trial NCT07146113 | AzTrials