Feasibility and Impact of Liquid Biopsy Genomic Profiling on Treatment Patients With Metastatic Prostate Cancer in Spain (SOLTI-2102) (HOPE-PROSTATE)
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ClinicalTrials.gov Identifier: NCT05885009 |
Recruitment Status :
Recruiting
First Posted : June 1, 2023
Last Update Posted : June 1, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Metastatic Prostate Cancer | Genetic: Liquid Biopsy Genetic: Archival Tumor DNA sequencing |
Study Type : | Observational |
Estimated Enrollment : | 240 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | 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) |
Actual Study Start Date : | March 28, 2023 |
Estimated Primary Completion Date : | March 28, 2026 |
Estimated Study Completion Date : | March 28, 2028 |
- Genetic: Liquid Biopsy
Patients with metastatic prostate cancer in disease progression or not receiving active systemic therapy will undergo a liquid biopsy
- Genetic: Archival Tumor DNA sequencing
Patients 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 [ Time Frame: Ongoing basis during 5 years of study duration ]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 [ Time Frame: Ongoing basis during 5 years of study duration ]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. [ Time Frame: Ongoing basis during 5 years of study duration ]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 [ Time Frame: Ongoing basis during 5 years of study duration ]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). [ Time Frame: Ongoing basis during 5 years of study duration ]
- 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. [ Time Frame: Ongoing basis during 5 years of study duration ]Percentage of patients who received a matched therapy against an alteration detected by ctDNA and/or tissue targeted sequencing during the follow-up period.
- Description Overall Survival (OS) among the included patients [ Time Frame: Ongoing basis during 5 years of study duration ]Describe OS from the moment of registration to the death of the patient.
- Description Progression Free Survival (PFS) of treatments aimed at identified alterations [ Time Frame: Ongoing basis during 5 years of study duration ]Describe PFS with treatments directed to molecular targets identified in ctDNA.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05885009
Spain | |
SOLTI Cancer Research Group | Recruiting |
Barcelona, Spain, 08008 | |
Contact: HOPE-Prostate Study Team (+34) 93 343 63 02 prostata.hope@gruposolti.org |
Responsible Party: | SOLTI Breast Cancer Research Group |
ClinicalTrials.gov Identifier: | NCT05885009 |
Other Study ID Numbers: |
SOLTI-2102 |
First Posted: | June 1, 2023 Key Record Dates |
Last Update Posted: | June 1, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
molecular advisory board molecular tumor board genomic data targeted therapy patient-centric trials |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |