Prevalence of Homologous Recombination Repair (HRR) Gene Mutations in Patients With Metastatic Castration-resistant Prostate Cancer in Latin America: PROSPECT Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 388
- Locations
- 1
- Primary Endpoint
- Primary Outcome
Study Overview
Brief Summary
Determine the prevalence of homologous recombination repair (HRR) gene mutations in participants with mCRPC in Latin America (LatAm) between February 2021 and January 2022.
Detailed Description
Background/Rationale: Prostate cancer(PC)is the second most frequent cancer diagnosis made in men and the fifth leading cause of death worldwide(1). Variations in the incidence rates world wide reflect differences in multiple epidemiological variables depending on the different regions. It is known that in Central America is the leading cause of cancer death in men. For South America, it is the second cause of cancer death and the third in North America(2). Estimations from 2012 from Brazil reported over 60,000 new cases. While in 2017 the United States (US) reported more than 160,000 new cases, represent in gone in five diagnosis of cancer in men (3-5).
The incidence of castration-resistant prostate cancer (CRPC)has been reported in several studies in various regions of the world, but unfortunately in Latin America data are incomplete. A comprehensive systematic review including 71,179 patients observed for up to 12 years, indicated that 10.0-20.0% of PC patients developed CRPC within approximately five years of follow-up. Over 84.0% of them had metastases present at the time of CRPC diagnosis, and 33.0% of those without metastases at diagnosis developed them within two years (3,4). Currently, patients with metastatic CRPC (mCRPC) have an overall survival rate between 9 and 13 months and is associated with bone metastases and poor quality of life (3.7). The negative prognosis of mCRPC may be associated in part with few and limited therapeutic options. In the past decade, there have been few new treatment options for this group of patients becoming an unmet need, but the development of targeted therapies and the application of PCD-damaged DNA repair mutation detection (DDR) tests allow patient classification and offer them important treatment options, particularly in advanced stages of the disease where current options are limited (8,9).
Objectives and Hypotheses Primary Objective: Determine the prevalence of homologous recombination repair (HRR) gene mutations in participants with mCRPC in Latin America(LatAm) between February 2021 and January 2022.
Exploratory objectives
- Describe the demographic and clinical characteristics of the mCRPC participants with HRR gene mutations in LatAm between February 2021 and January 2022.
- Describe the association between demographic and clinical characteristics, and the prevalence of HRR gene mutations in participants with mCRPC per LatAm country between February 2021 and January 2022.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged≥18
- •Pathological mCRPC cases confirmed by histopathological report.
- •Evidence of a previous methastatic primary PC
- •Availability to provide medical history data(demographic information and history of cancer).
- •Availability to provide blood and/or tissue sample in case it is available
- •Participants who are able to sign the informed consent form(ICF).
Exclusion Criteria
- •Diagnosis of any severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results
- •Inability of participant to provide informed consent.
Outcomes
Primary Outcomes
Primary Outcome
Time Frame: Q1 2021 - Q1 2022
To know the prevalence and type of Homologous Recombinational Repair (HRR) mutations identified in Formalin-fixed paraffin-embedded (FFPE) tissue or blood samples in patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) in the selected participants countries in LatAm. A molecular test formulary would be completed when tissue sample is analyzed * Preservation time (years) * Origin of the FFPE (organ) * HRR mutation status (32 mutations would be analyzed and each of them would have as an answer "positive"/"negative"/"VUS") A molecular test formulary would be completed when blood sample is analyzed * Date of extraction (date) * HRR mutation status (32 mutations would be analyzed and each of them would have as an answer "positive"/"negative"/"VUS")
Secondary Outcomes
No secondary outcomes reported