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

NCT07146113 | Recruiting

• 1 other identifier: D133HR00058
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 17

Brief Summary

A multicentre observational study on treatment approaches and biomarkers in de novo metastatic hormone sensitive prostate cancer in Russian Federation

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (12)

• Proportion of patients received any ADT

  Proportion of patients received any Androgen deprivation therapy (ADT)

  24 months

• 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;

  24 months

• Proportion of patients received first generation antiandrogens

  Proportion of patients received first generation antiandrogens;

  24 months

• 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;

  24 months

• Proportion of patients received any chemotherapy at mHSPC

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

  24 months

• Duration of chemotherapy

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

  24 months

• Proportion of patients received radiation therapy

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

  24 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);

  24 months

• 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);

  24 months

• Proportion of patients received triplet therapy

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

  24 months

• Proportion of patients with PTEN loss by IHC

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

  24 months

• 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.

  24 months

Secondary Outcomes (14)

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

  24 months

• Proportion of patients of different races and ethnicities

  24 months

• Proportion of patients with presence of a family oncology history

  24 months

• Proportion of patients with a personal oncology history

  24 months

• Proportion of patients with each category by ECOG assessment

  24 months

Other Outcomes (6)

• Median time from de novo high-aggressive histologically confirmed mPC diagnosis to progression to mCRPC

  24 months

• Proportion of patients with each site of disease progression

  24 months

• Testosterone level at the time of mCRPC diagnosis

  24 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients aged ≥ 18 years old
• 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 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.

You may qualify if:

• 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;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (17)

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

RECRUITING

Research Site

Moscow, Russia

NOT YET RECRUITING

Research Site

Moscow, Russia

RECRUITING

Research Site

Nizhny Novgorod, Russia

NOT YET RECRUITING

Research Site

Obninsk, Russia

RECRUITING

Research Site

Omsk, Russia

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

NOT YET RECRUITING

Research Site

Ufa, Russia

NOT YET 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: August 28, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

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 (17)