Clinical trial · Observational
PROMET-BR - Molecular Profiling of Metastatic Prostate Cancer: a Brazilian Cohort
A Retrospective and Prospective Study Aiming to Characterize Molecular Alterations and Clinical Outcomes of Metastatic Prostate Cancer in a Real-world Cohort of Patients Eligible to Palliative Systemic Therapy at Oncoclínicas & Co Group
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Archived FFPE tissue biopsy and/or newly acquired liquid biopsy for molecular profiling. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- metastatic prostate cancer receiving palliative systemic therapy at Oncoclínicas & Co
- description
- metastatic prostate cancer receiving palliative systemic therapy at Oncoclínicas \& Co
- interventionNames
- Diagnostic Test: Archived FFPE tissue biopsy and/or newly acquired liquid biopsy for molecular profiling.
Primary outcomes (2)
- measure
- prevalence of HRR mutations in tissue and/or liquid biopsy samples
- timeFrame
- april 2026 to april 2027
- description
- 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;
- measure
- prevalence of PTEN loss of expression in tissue samples
- timeFrame
- april 2026 to april 2027
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available