PROMET-BR - Molecular Profiling of Metastatic Prostate Cancer: a Brazilian Cohort

NCT07560215 | Not Yet Recruiting

• 1 other identifier: D3612R00027
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

PROMET-BR is an observational, retrospective and prospective real-world study in Brazil designed to characterize clinically relevant molecular alterations in metastatic prostate cancer and explore their association with patient outcomes in routine practice. The study will be conducted within Oncoclínicas \& Co and will integrate centralized biomarker testing performed at OC Precision Medicine laboratories with retrospectively assembled clinical data from electronic health records (EHRs) from participating sites. Treatments are not assigned by the protocol; patients receive standard-of-care palliative systemic therapy at the discretion of their treating physicians.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• prevalence of HRR mutations in tissue and/or liquid biopsy samples

  to describe the prevalence of HRR mutations in tissue and/or liquid biopsy samples from metastatic prostate cancer using validated tissue next-generation sequencing (NGS) assays developed in-house at OC Precision Medicine;

  april 2026 to april 2027

• prevalence of PTEN loss of expression in tissue samples

  to describe the prevalence of PTEN loss of expression in tissue samples using validated immunohistochemistry (IHC) assay Ventana PTEN (SP218) antibody.

  april 2026 to april 2027

Secondary Outcomes (1)

• assess the analytical validity of a liquid biopsy NGS assay developed in-house

  april 2026 to april 2027

Study Arms (1)

metastatic prostate cancer receiving palliative systemic therapy at Oncoclínicas & Co

metastatic prostate cancer receiving palliative systemic therapy at Oncoclínicas \& Co

Diagnostic Test: Archived FFPE tissue biopsy and/or newly acquired liquid biopsy for molecular profiling.

Interventions

Archived FFPE tissue biopsy and/or newly acquired liquid biopsy for molecular profiling. DIAGNOSTIC_TEST

The exposure/intervention under investigation is the use of archived FFPE tissue biopsy and/or newly acquired liquid biopsy for molecular profiling.

metastatic prostate cancer receiving palliative systemic therapy at Oncoclínicas & Co

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

100 patients with metastatic prostate cancer receiving palliative systemic therapy at Oncoclínicas \& Co will be recruited in the study. This will include retrospectively identified population with enough FFPE tissue available for tumor molecular analysis at OC Precision Medicine Lab who have started palliative treatment at OC clinics, as well as prospectively identified patients that are be eligible to tissue molecular profiling and will start treatment at Oncoclínicas \& Co clinics. In parallel, we will prospectively recruit 30 patients in the liquid biopsy cohort, which will include patients known to have tumors with HRR mutations (based on GS Focus HRR or any other validated NGS assays) as well as those who had NGS tissue failure and have been prospectively recruited in the study.

You may qualify if:

• Adult patients age \>= 18 years; clinical diagnosis of metastatic prostate cancer (irrespective of hormone-sensitivity or castration-resistance status); eligible to palliative therapy for metastatic prostate cancer at Oncoclínicas \& Co in 2023 onwards; sufficient FFPE tissue available for molecular profiling. For the subset of patients prospectively selected to liquid biopsy cohort, clinical or radiological evidence of disease progression at the sample collection, and with at least 14 days of treatment interval from last dose of systemic anticancer therapy or radiotherapy to liquid biopsy.

You may not qualify if:

• No tissue FFPE tissue available for molecular profiling (except in prospective liquid biopsy cohort); less than 3 months follow-up from start of palliative therapy for metastatic prostate cancer at Oncoclínicas \& Co.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

São Paulo, Brazil

Location

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

Study Information Center

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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 refer 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

BR (1)