Clinical trial · Observational
CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.
Biomarkers Study: Circulating Tumor Cells (CTC), Free DNA, Stem Cells and Epithelial-mesenchymal-transition (EMT) Related Antigens as Biomarkers of Activity of Cabazitaxel in Castration-resistant Prostate Cancer (CRPC): a Proof of Concept.
NCT03381326CI-TRIAL-00066870IRSTB030unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Identification of biomarkers (Circulating Tumor Cells (CTC), free DNA, Stem Cells and EMT-related antigens) that may be predictive of outcome of activity of cabazitaxel treatment in castration-resistant prostate cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Circulating Tumor Cells | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood and FFPE sample collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 36 months
- description
- time between the start of cabazitaxel and the first date of progression as measured by PCWG-2 criteria.
Secondary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 36 months
- description
- The overall survival will be calculated from date of the start of cabazitaxel to death
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document 2. Male aged \>18 years with metastatic castration-resistant disease with documented clinical (imaging) and/or biochemical progression (PSA increasing values) during or after a previous docetaxel-based chemotherapy 3. Patients must have metastatic and/or inoperable disease 4. Patients must have received prior therapy docetaxel based and must be candidate to cabazitaxel 5. Life expectancy of greater than 3 months 6. Eastern Cooperative Oncology Group (ECOG) performance status \<2 Exclusion Criteria: 1. Participants who are unable to provide informed consent 2. Participation in another clinical trial
References
Publications (2)
- DERIVEDGurioli G, Conteduca V, Brighi N, Scarpi E, Basso U, Fornarini G, Mosca A, Nicodemo M, Banna GL, Lolli C, Schepisi G, Ravaglia G, Bondi I, Ulivi P, De Giorgi U. Circulating tumor cell gene expression and plasma AR gene copy number as biomarkers for castration-resistant prostate cancer patients treated with cabazitaxel. BMC Med. 2022 Jan 31;20(1):48. doi: 10.1186/s12916-022-02244-0. PMID 35101049
- DERIVEDConteduca V, Wetterskog D, Castro E, Scarpi E, Romero-Laorden N, Gurioli G, Jayaram A, Lolli C, Schepisi G, Wingate A, Casadei C, Lozano R, Brighi N, Aragon IM, Marin-Aguilera M, Gonzalez-Billalabeitia E, Mellado B, Olmos D, Attard G, De Giorgi U. Plasma androgen receptor and response to adapted and standard docetaxel regimen in castration-resistant prostate cancer: A multicenter biomarker study. Eur J Cancer. 2021 Jul;152:49-59. doi: 10.1016/j.ejca.2021.04.025. Epub 2021 May 30. PMID 34077818