We hypothesize that an improved understanding of the cellular heterogeneity, both between patients and within a single patient, will aid in developing improved individualized treatment strategies.
ID
Bron
Verkorte titel
Aandoening
Prostate cancer, Metastatic hormone sensitive prostate cancer, mHSPC
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The percentage of patients from who 30 single viable CTCs can be isolated from the DLA product.
Achtergrond van het onderzoek
The number of treatment options for patients with high-risk metastatic Hormone Sensitive Prostate Cancer (mHSPC) are rapidly expanding. Both chemotherapy and intensified anti-hormonal treatments deliver a significant improvement in overall survival. However, we are currently unable to predict which therapies are most effective in individual patients and the scarce randomized trial data comparing the 2 modalities fail to identify a clear preference. Thus, developing predictive biomarkers may provide an improved scientific basis to further improve the treatment of mHSPC patients. We will study a novel single cell phenotyping platform that enables the “ex vivo” testing of heterogeneity in drug responsiveness on individual tumor cells. We aim to correlate the results of the “ex vivo” single cell drug responsiveness testing to the clinical outcome in patients and to generate hypotheses on how and whether this novel technology could help to stratify patients with mHSPC for treatment allocation.
Doel van het onderzoek
We hypothesize that an improved understanding of the cellular heterogeneity, both between patients and within a single patient, will aid in developing improved individualized treatment strategies.
Onderzoeksopzet
- Baseline: -28 days till -1 day
- DLA
- After 6 months of treatment
- At progression of disease
- Death
Onderzoeksproduct en/of interventie
From all patients, blood will be drawn to screen for eligibility, including a CellSave tube for circulating tumorcells count and circulating tumor DNA, tubes for liver, renal and bone marrow function. If eligible, patients will undergo a diagnostic leukapheresis (DLA) procedure.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
• ≥ 2 adequate peripheral veins as access point for leukapheresis.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Known hypersensitivity to the anticoagulant used for apheresis
• Inadequate cardiac function or severe cardiovascular comorbidity
- Heart failure NYHA class III/IV
• Hemoglobin level < 6.0 mmol/L
• Coagulation disorders as defined by one of the following:
- Coagulation disorder in medical history
- Platelet count < 40 x 109/L;
Patients without anticoagulant therapy which affects PT or APTT, when:
- PT > 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8549 |
| Ander register | METC Erasmus MC : MEC-2020-0422 / NL73860.078.20 |