Feasibility and Impact of Liquid Biopsy Genomic Profiling on Treatment Patients With Metastatic Prostate Cancer in Spain (SOLTI-2102)

NCT05885009 | Recruiting

• 1 other identifier: SOLTI-2102
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Prostate Cancer

Keywords

molecular advisory board; molecular tumor board; genomic data; targeted therapy; patient-centric trials

Outcome Measures

Primary Outcomes (2)

• 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.

  Ongoing basis during 5 years of study duration

• 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.

  Ongoing basis during 5 years of study duration

Secondary Outcomes (6)

• To describe the genomic landscape of mPC in a real-world population beyond clinical trials using validated targeted sequencing assays in tissue and ctDNA.

  Ongoing basis during 5 years of study duration

• To study the feasibility of liquid-biopsy based genomic testing in patient subsets: metastatic hormone-naïve and castration-resistant mPC

  Ongoing basis during 5 years of study duration

• 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).

  Ongoing basis during 5 years of study duration

• To study the clinical impact of genomic testing in terms of matched therapies prescribed from treating physicians.

  Ongoing basis during 5 years of study duration

• Description Overall Survival (OS) among the included patients

  Ongoing basis during 5 years of study duration

Interventions

Liquid Biopsy GENETIC

Patients with metastatic prostate cancer in disease progression or not receiving active systemic therapy will undergo a liquid biopsy

Archival Tumor DNA sequencing GENETIC

Patients will be prompted to request an archival tumor sample from metastatic origin (preferably) and to send it to the central laboratory for analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients diagnosed with metastatic prostate cancer living and being treated in Spain.

You may qualify if:

• 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).
• 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.
• Eastern Cooperative Oncology Group (ECOG) 0-1.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead
• Pfizer: collaborator
• AstraZeneca: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Advanced Accelerator Applications: collaborator
• Astellas Pharma Inc: collaborator
• Guardant Health, Inc.: collaborator

Study Sites (1)

SOLTI Cancer Research Group

Barcelona, 08008, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample collection and archival tumor tissue collection

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 1, 2023
• Study Start: March 28, 2023
• Primary Completion: March 28, 2026
• Study Completion (Estimated): March 28, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

ES (1)