HOPE Prostate is an observational study that aims at promoting research against metastatic prostate cancer by means of collective research led by patients (patient-centric trial). Patients with metastatic prostate cancer living in Spain will voluntarily register and fulfil their journey in the study through the study's digital tool. Mainly they are prompted to answer questionnaires about their disease, and to provide a blood sample and an archival tumor biopsy. In HOPE Prostate these samples will be genomically analyzed and every patient case will be presented in a multidisciplinary molecular advisory board (MAB). The MAB will issue a plain report explaining the significance of the results and will try to enumerate future therapeutic options that match patient history and his genomic profile. Finally, patients will have to answer short follow-up questionnaires twice a year for 3 years.
The study data will allow us to advance implementing precision medicine to improve the management of current and specially future metastatic prostate cancer patients.
Male patients living in Spain.
Age ≥18 years.
Signed informed consent before any screening procedure.
Metastatic PC of any subtype confirmed both pathologically and radiologically (stage IV disease).
Inability to consent or conform to the processes involved in a clinical study.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Male patients diagnosed with metastatic prostate cancer living and being treated in Spain.
Other
Prospective
Liquid Biopsy
GeneticPatients with metastatic prostate cancer in disease progression or not receiving active systemic therapy will undergo a liquid biopsy
Archival Tumor DNA sequencing
GeneticPatients will be prompted to request an archival tumor sample from metastatic origin (preferably) and to send it to the central laboratory for analysis
To evaluate the feasibility of a liquid-biopsy based Comprehensive Genomic Panel (CGP) test in the management of mPC patients, following a patient-centric approach
Percentage of patients for whom a liquid biopsy result can be obtained.
To evaluate the impact of a liquid-biopsy based CGP test in the management of mPC patients, following a patient-centric approach
Proportion of patients with a putatively targetable (ESCAT levels I-III) alteration detected.
To describe the genomic landscape of mPC in a real-world population beyond clinical trials using validated targeted sequencing assays in tissue and ctDNA.
Frequency of PC gene mutations in the study population including DNA repair pathways (BRC1/2 inactivating mutations, etc.), genes associated with phosphatidylinositol-3 kinase (PI3K) and cell cycle regulation pathways and others.
To study the feasibility of liquid-biopsy based genomic testing in patient subsets: metastatic hormone-naïve and castration-resistant mPC
ctDNA detection rate in hormone-naïve and castration-resistant mPC.
To study the concordance rate for key genomic alterations between ctDNA and tumor targeted sequencing (in a subset of patients who have both samples available).
* Concordance between ctDNA mutation status and tissue mutation status (specially in Homologous Recombination Repair and other clinically relevant genes). * Concordance between ctDNA and tissue TMB calculations. * Concordance between ctDNA and tissue Variant Allelle Frequency for given mutations.
To study the clinical impact of genomic testing in terms of matched therapies prescribed from treating physicians.
Percentage of patients who received a matched therapy against an alteration detected by ctDNA and/or tissue targeted sequencing during the follow-up period.
Click on the lead sponsor to view all of their trials.
SOLTI Breast Cancer Research Group
Lead sponsor
Pfizer
Collaborator
AstraZeneca
Collaborator
Merck Sharp & Dohme LLC
Collaborator
Advanced Accelerator Applications
Collaborator
Astellas Pharma Inc
Collaborator
Guardant Health, Inc.
Collaborator
