Prostate CancerIRSTB030NCT03381326
CTC, Free DNA, Stem Cells and EMT-related Antigens as Biomarkers of Activity of Cabazitaxel in CRPC.
An observational study of Prostate Cancer and Metastatic Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 9 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Cancer, Castration-resistant Prostate Cancer
- What is being tested?
- blood and FFPE sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 104 participants
- Where
- 9 sitesItaly
- Study dates
- 15 Dec 2014to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with castration-resistant prostate cancer
Who may be able to join
- 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
Who cannot join
- Participants who are unable to provide informed consent
- Participation in another clinical trial
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Ospedali Riuniti Umberto I
Ancona, AN
Azienda Ospedaliera Cannizzaro
Catania
IRCCS AOU San martino IST
Genova, GE, 16132
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, 47014
Ospedale Maggiore della Carità
Novara
Istituto Oncologico del Veneto (IOV) - Università di Padova
Padova
Ospedale Civile degli Infermi
Rimini, RN
Policlinico Universitario Campus Bio-Medico
Roma
Ospedale Sacro Cuore Don Calabria (Negrar)
Verona
About this study
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.
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.
Read the 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.
- Conditions
- Prostate Cancer, Metastatic Cancer, Castration-resistant Prostate Cancer, Circulating Tumor Cells
- Being tested
- blood and FFPE sample collection
- Keywords
- circulating tumor cells, Castration-resistant Prostate Cancer, cabazitaxel, biomarker, free DNA, stem cells, EMT related antigens
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and FFPE sample collectionProcedure or surgery
blood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
time between the start of cabazitaxel and the first date of progression as measured by PCWG-2 criteria.
Measured: 36 months
Secondary outcomes (1)
Overall survival (OS)
The overall survival will be calculated from date of the start of cabazitaxel to death
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start15 Dec 2014
- Primary completionOct 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugo De Giorgi, Principal investigator, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381326
- Sponsor's protocol ID
- IRSTB030
- Acronym
- IRSTB030
- Status last verified
- May 2023
- First submitted
- 18 Dec 2017
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35101049Conteduca 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.
PubMed 34077818
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03381326
- Acronym / sponsor ID
- IRSTB030 / IRSTB030
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with castration-resistant prostate cancer
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Participants who are unable to provide informed consent
- Participation in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and FFPE sample collectionblood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection | Procedure or surgery | – |
Primary outcome
Progression free survival (PFS)
Time frame: 36 months
time between the start of cabazitaxel and the first date of progression as measured by PCWG-2 criteria.
1 secondary outcome
Overall survival (OS)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Derived from this study: PubMed 35101049Gurioli 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.
- Derived from this study: PubMed 34077818Conteduca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugo De Giorgi principal investigator
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Metastatic Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381326, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.