PROMET-BR - Molecular Profiling of Metastatic Prostate Cancer: a Brazilian Cohort
ConditionMetastatic Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-99
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Archived FFPE tissue biopsy and/or newly acquired liquid biopsy for molecular profiling.
Diagnostic testThe exposure/intervention under investigation is the use of archived FFPE tissue biopsy and/or newly acquired liquid biopsy for molecular profiling.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: metastatic prostate cancer receiving palliative systemic therapy at Oncoclínicas & Co1 intervention
Trial outcomes
Primary outcomes
1
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;
Time frame
april 2026 to april 20272
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.
Time frame
april 2026 to april 2027Secondary outcomes
1
assess the analytical validity of a liquid biopsy NGS assay developed in-house
to assess the analytical validity of a liquid biopsy NGS assay developed in-house at OC Precision Medicine (GS Focus Liquid) as an alternative test to tissue NGS failure/inconclusive results
Time frame
april 2026 to april 2027Sponsors and contacts
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Source ClinicalTrials.gov
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