NCT03381326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

4.8 years

First QC Date

December 18, 2017

Last Update Submit

June 1, 2023

Conditions

Prostate CancerMetastatic CancerCastration-resistant Prostate CancerCirculating Tumor Cells

Keywords

circulating tumor cellsCastration-resistant Prostate Cancercabazitaxelbiomarkerfree DNAstem cellsEMT related antigens

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    time between the start of cabazitaxel and the first date of progression as measured by PCWG-2 criteria.

    36 months

Secondary Outcomes (1)

  • Overall survival (OS)

    36 months

Interventions

blood and FFPE sample collectionPROCEDURE

blood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with castration-resistant prostate cancer

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document
  • 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
  • Patients must have metastatic and/or inoperable disease
  • Patients must have received prior therapy docetaxel based and must be candidate to cabazitaxel
  • Life expectancy of greater than 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status \<2

You may not qualify if:

  • Participants who are unable to provide informed consent
  • Participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Ospedali Riuniti Umberto I

Ancona, AN, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

Location

IRCCS AOU San martino IST

Genova, GE, 16132, Italy

Location

Ospedale Civile degli Infermi

Rimini, RN, Italy

Location

Azienda Ospedaliera Cannizzaro

Catania, Italy

Location

Ospedale Maggiore della Carità

Novara, Italy

Location

Istituto Oncologico del Veneto (IOV) - Università di Padova

Padua, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, Italy

Location

Ospedale Sacro Cuore Don Calabria (Negrar)

Verona, Italy

Location

Related Publications (2)

  • 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.

    PMID: 35101049DERIVED

  • 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.

    PMID: 34077818DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and FFPE samples

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm MetastasisNeoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ugo De Giorgi

    Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 22, 2017

Study Start

December 15, 2014

Primary Completion

October 1, 2019

Study Completion

December 1, 2023

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations

IT(9)