Clinical trial NCT03381326: CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Metastatic Cancer
Castration-resistant Prostate Cancer
Circulating Tumor Cells
Keywords: circulating tumor cells
Castration-resistant Prostate Cancer
cabazitaxel
biomarker
free DNA
stem cells
EMT related antigens
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with castration-resistant prostate cancer

Brief summary: 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.

Detailed description: Circulating Tumor Cells, free DNA, Stem Cells and EMT-related antigens as biomarkers of activity of cabazitaxel in castration-resistant prostate cancer

Primary objectives: To evaluate the prognostic role of response of the copy number of androgen receptor (AR) and Phosphatase and tensin homolog (PTEN) and AR-V7 and other gene expression biomarkers in CTC and the investigators will compare these results with those obtained in plasma cell free DNA and RNA.

Eligible patients must have histologically or cytologically confirmed prostate cancer or unequivocal increased PSA . Metastatic and/or inoperable disease and received prior therapy with docetaxel and candidate to cabazitaxel treatment.

All patients receive cabazitaxel at standard schedule 25 mg/m2 q21. Blood sample will be collected for CTC evaluation at baseline, after the first cycle of therapy (optional), at first radiological evaluation (after 3 months), at disease progression (optional) or after 9-12 months of treatment for patients who did not show disease progression (optional). Disease progression defined according to Prostate Cancer Working Group 2 (PCWG2) criteria. On blood samples from Castration-Resistant Prostate Cancer (CRPC) patients the investigators will investigate the presence of the previously presented CTC, DNA and RNA free markers.

As an option, it will be possible to require a sample of the tumor collected during prostate surgery or during the biopsy.

All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti Umberto I
state: AN
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: FC
city: Genova
country: Italy
facility: IRCCS AOU San martino IST
state: GE
city: Rimini
country: Italy
facility: Ospedale Civile degli Infermi
state: RN
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
city: Padova
country: Italy
facility: Istituto Oncologico del Veneto (IOV) - Università di Padova
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Verona
country: Italy
facility: Ospedale Sacro Cuore Don Calabria (Negrar)
Study officials:
affiliation: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
name: Ugo De Giorgi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gurioli 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.
citation: Conteduca 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.