Probing Intercellular heterogeneity in Circulating TUmor cells of de novo metastatic Hormone Sensitive Prostate CanceR patiEntS

Probing Intercellular heterogeneity in Circulating TUmor cells of de novo metastatic Hormone Sensitive Prostate CanceR patiEntS - PICTURES

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49282

Enrollment

134

Registered

2020-07-16

Start date

2020-09-07

Completion date

Unknown

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic hormone sensitive prostate cancer metastatic prostate cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - De novo mHSPC patient, no prior treatment for prostate cancer, including local treatments and ADT - Intention to start treatment with ADT + docetaxel or ADT + Second Generation Androgen Receptor Targeted therapy - Age >=18 years - WHO performance status = 2 adequate peripheral veins as access point for leukapheresis.

Exclusion criteria

Exclusion criteria: - Known hypersensitivity to the anticoagulant used for apheresis - Inadequate cardiac function or severe cardiovascular comorbidity * Heart failure NYHA class III/IV - Hemoglobin level 1.5 x ULN or PT-INR > 1.5 x ULN * APTT > 1.5 x ULN Patients with anticoagulant therapy which affects PT or APTT, when: * PT or APTT > 1.5 x the upper limit of the desired therapeutic window * Total bilirubin > 2.5 x ULN - Known chronic viral infections - Second active malignancy

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is: - The percentage of patients from who 30 single viable CTCs can be isolated from the DLA product.	—

Secondary

Measure	Time frame
Secondary endpoints of this study are: - The number of CTC in mHSPC patients obtained in peripheral blood and obtained by DLA - The correlation between the number of CTC at baseline and after six months of treatment (defined as 6 months from start treatment for mHSPC) to clinical outcome (defined as time to start mCRPC treatment, time to first line therapy for CRPC, time to mCPRC as defined by PCWG3 and overall survival) - The level of PSA secretion and cell stress factors on single CTCs after drug exposure - The percentage of patients from whom chromosomal profiles of single CTCs can be successfully generated - The levels of ctDNA in mHSPC patients obtained in peripheral blood at baseline and after six months. Exploratory endpoints of this study are: - The intra-patient and inter-patient heterogeneity in genotype and phenotype of single CTCs - The correlation between genotypic and phenotypic characterization of single CTCs - The correlation between genomic heterogeneity and phenotypic heterogeneity of individual cancer cells in poor and well responding mHSPC patients.	—

Measure

Time frame

Secondary endpoints of this study are: - The number of CTC in mHSPC patients obtained in peripheral blood and obtained by DLA - The correlation between the number of CTC at baseline and after six months of treatment (defined as 6 months from start treatment for mHSPC) to clinical outcome (defined as time to start mCRPC treatment, time to first line therapy for CRPC, time to mCPRC as defined by PCWG3 and overall survival) - The level of PSA secretion and cell stress factors on single CTCs after drug exposure - The percentage of patients from whom chromosomal profiles of single CTCs can be successfully generated - The levels of ctDNA in mHSPC patients obtained in peripheral blood at baseline and after six months. Exploratory endpoints of this study are: - The intra-patient and inter-patient heterogeneity in genotype and phenotype of single CTCs - The correlation between genotypic and phenotypic characterization of single CTCs - The correlation between genomic heterogeneity and phenotypic heterogeneity of individual cancer cells in poor and well responding mHSPC patients.

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Countries

Netherlands

Outcome results