Clinical trial · Observational
Feasibility and Impact of Liquid Biopsy Genomic Profiling on Treatment Patients With Metastatic Prostate Cancer in Spain (SOLTI-2102)
Real World Clinical Practice Study to Assess the Feasibility and Impact of Liquid Biopsy-based Genomic Profiling on Treatment Decision Making for Patients With Metastatic Prostate Cancer in Spain (SOLTI-2102)
- 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)
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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Archival Tumor DNA sequencing | Genetic | — | UNRESOLVED |
| Liquid Biopsy | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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
- timeFrame
- Ongoing basis during 5 years of study duration
- description
- Percentage of patients for whom a liquid biopsy result can be obtained.
- measure
- To evaluate the impact of a liquid-biopsy based CGP test in the management of mPC patients, following a patient-centric approach
- timeFrame
- Ongoing basis during 5 years of study duration
- description
- Proportion of patients with a putatively targetable (ESCAT levels I-III) alteration detected.
Secondary outcomes (6)
- measure
- To describe the genomic landscape of mPC in a real-world population beyond clinical trials using validated targeted sequencing assays in tissue and ctDNA.
- timeFrame
- Ongoing basis during 5 years of study duration
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male patients living in Spain. 2. Age ≥18 years. 3. Signed informed consent before any screening procedure. 4. Metastatic PC of any subtype confirmed both pathologically and radiologically (stage IV disease). 5. The subjects must be about to receive, or receiving, or will have completed treatment for their metastatic disease with any line of treatment in either a clinical trial or the standard of care healthcare setting. 6. Eastern Cooperative Oncology Group (ECOG) 0-1. Exclusion Criteria: 1. Inability to consent or conform to the processes involved in a clinical study. 2. 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.
References
Publications (0)
Data not yet available