Prostatic NeoplasmsNCT04964271
Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
An observational study of Prostatic Neoplasms, run by Tethis S.p.A. at 1 site in Italy.
Trial summary
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from among the people who visit the urology department
Who may be able to join
- Participant is willing and able to give and sign a written informed consent for participation in the study
- Male, aged 18 years or above
- Diagnosed with prostate cancer at low or high risk
- Candidate to active surveillance (in case of low-risk disease) or treatment with curative intent such as radical prostatectomy or radiation therapy (in case of low risk patients not willing to undergo active surveillance or patients with high risk disease)
- Healthy participants undergoing a visit at the site for reason other than cancer diagnosis (including prostate cancer)
Who cannot join
- History of other malignancies other than prostate cancer (for healthy participants includes also prostate cancer)
- Undergone surgery or treatment for prostate cancer before enrolment
- Presence of known severe coagulation or haematological disorder
- Absence of written signed informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Prostate Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.
Read the detailed description
In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by patients affected by prostate cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different risk categories:20 participants affected by prostate cancer at low risk, 20 participants affected by prostate cancer at high risk, and 20 participants without a cancer disease (healthy volunteers) as control.
Risk categorization is based on the definition of the European Association of Urology. After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the participants and shipped to Sponsor's laboratories, in order to be processed and analysed.
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate cancer biomarker, circulating tumoral cell, immunofluorescence assay, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low risk prostate cancer patients | Prostate cancer risk category is based on the definition of the European Association of Urology, namely low risk (PSA (prostate-specific antigen) <10 ng/ml, and stage T1/T2a and Gleason score 3+3). | |
| High risk prostate cancer patients | Prostate cancer risk category is based on the definition of the European Association of Urology, namely high risk (PSA (prostate-specific antigen) >20 ng/ml or stage T3 or higher or biopsy Gleason score 8-10). | |
| Healthy donor | Participants who are in good health and without history of cancer disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers
Qualitative assessment of Staining Positivity for different Prostate Cancer Biomarkers
Measured: day 1 : blood collection day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start9 Sep 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tethis S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto Briganti, MD, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964271
- Sponsor's protocol ID
- TET-21-002
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2021
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a basic research study without an IPD information sharing plan
Publications
Hench IB, Hench J, Tolnay M. Liquid Biopsy in Clinical Management of Breast, Lung, and Colorectal Cancer. Front Med (Lausanne). 2018 Jan 30;5:9. doi: 10.3389/fmed.2018.00009. eCollection 2018.
PubMed 29441349Rawal S, Yang YP, Cote R, Agarwal A. Identification and Quantitation of Circulating Tumor Cells. Annu Rev Anal Chem (Palo Alto Calif). 2017 Jun 12;10(1):321-343. doi: 10.1146/annurev-anchem-061516-045405. Epub 2017 Mar 6.
PubMed 28301753Carbone R, Marangi I, Zanardi A, Giorgetti L, Chierici E, Berlanda G, Podesta A, Fiorentini F, Bongiorno G, Piseri P, Pelicci PG, Milani P. Biocompatibility of cluster-assembled nanostructured TiO2 with primary and cancer cells. Biomaterials. 2006 Jun;27(17):3221-9. doi: 10.1016/j.biomaterials.2006.01.056. Epub 2006 Feb 28.
PubMed 16504283Zanardi A, Bandiera D, Bertolini F, Corsini CA, Gregato G, Milani P, Barborini E, Carbone R. Miniaturized FISH for screening of onco-hematological malignancies. Biotechniques. 2010 Jul;49(1):497-504. doi: 10.2144/000113445.
PubMed 20615202Krol I, Schwab FD, Carbone R, Ritter M, Picocci S, De Marni ML, Stepien G, Franchi GM, Zanardi A, Rissoglio MD, Covelli A, Guidi G, Scarinci D, Castro-Giner F, Mazzarella L, Doglioni C, Borghi F, Milani P, Kurzeder C, Weber WP, Aceto N. Detection of clustered circulating tumour cells in early breast cancer. Br J Cancer. 2021 Jul;125(1):23-27. doi: 10.1038/s41416-021-01327-8. Epub 2021 Mar 24.
PubMed 33762721Scher HI, Graf RP, Schreiber NA, McLaughlin B, Jendrisak A, Wang Y, Lee J, Greene S, Krupa R, Lu D, Bamford P, Louw JE, Dugan L, Vargas HA, Fleisher M, Landers M, Heller G, Dittamore R. Phenotypic Heterogeneity of Circulating Tumor Cells Informs Clinical Decisions between AR Signaling Inhibitors and Taxanes in Metastatic Prostate Cancer. Cancer Res. 2017 Oct 15;77(20):5687-5698. doi: 10.1158/0008-5472.CAN-17-1353. Epub 2017 Aug 17.
PubMed 28819021Xu L, Jia S, Li H, Yu Y, Liu G, Wu Y, Liu X, Liu C, Zhou Y, Zhang Z, Sheng Y. Characterization of circulating tumor cells in newly diagnosed breast cancer. Oncol Lett. 2018 Feb;15(2):2522-2528. doi: 10.3892/ol.2017.7540. Epub 2017 Dec 6.
PubMed 29434968Roviello G, Corona SP, Bonetta A, Cappelletti MR, Generali D. Circulating tumor cells correlate with patterns of recurrence in patients with hormone-sensitive prostate cancer. Onco Targets Ther. 2017 Jul 31;10:3811-3815. doi: 10.2147/OTT.S143020. eCollection 2017.
PubMed 28814879
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Characterization of Commercial RUO Antibodies for the Detection of Specific Prostate Cancer Tumoral Markers Expressed in Potential Circulating Tumoral Cells (CTCs)
- ClinicalTrials.gov ID
- NCT04964271
- Acronym / sponsor ID
- TET-21-002
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate cancer biomarker, circulating tumoral cell, immunofluorescence assay, prostate cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tethis S.p.A.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jul 2021 (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.
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.
Detailed description
In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by patients affected by prostate cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different risk categories:20 participants affected by prostate cancer at low risk, 20 participants affected by prostate cancer at high risk, and 20 participants without a cancer disease (healthy volunteers) as control.
Risk categorization is based on the definition of the European Association of Urology. After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the participants and shipped to Sponsor's laboratories, in order to be processed and analysed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk prostate cancer patients | – | –Prostate cancer risk category is based on the definition of the European Association of Urology, namely low risk (PSA (prostate-specific antigen) <10 ng/ml, and stage T1/T2a and Gleason score 3+3). |
| High risk prostate cancer patients | – | –Prostate cancer risk category is based on the definition of the European Association of Urology, namely high risk (PSA (prostate-specific antigen) >20 ng/ml or stage T3 or higher or biopsy Gleason score 8-10). |
| Healthy donor | – | –Participants who are in good health and without history of cancer disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from among the people who visit the urology department
Key inclusion criteria (5 listed)
- Participant is willing and able to give and sign a written informed consent for participation in the study
- Male, aged 18 years or above
- Diagnosed with prostate cancer at low or high risk
- Candidate to active surveillance (in case of low-risk disease) or treatment with curative intent such as radical prostatectomy or radiation therapy (in case of low risk patients not willing to undergo active surveillance or patients with high risk disease)
- Healthy participants undergoing a visit at the site for reason other than cancer diagnosis (including prostate cancer)
Key exclusion criteria (4 listed)
- History of other malignancies other than prostate cancer (for healthy participants includes also prostate cancer)
- Undergone surgery or treatment for prostate cancer before enrolment
- Presence of known severe coagulation or haematological disorder
- Absence of written signed informed consent for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers
Time frame: day 1 : blood collection day
Qualitative assessment of Staining Positivity for different Prostate Cancer Biomarkers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 29441349Hench IB, Hench J, Tolnay M. Liquid Biopsy in Clinical Management of Breast, Lung, and Colorectal Cancer. Front Med (Lausanne). 2018 Jan 30;5:9. doi: 10.3389/fmed.2018.00009. eCollection 2018.
- Background: PubMed 28301753Rawal S, Yang YP, Cote R, Agarwal A. Identification and Quantitation of Circulating Tumor Cells. Annu Rev Anal Chem (Palo Alto Calif). 2017 Jun 12;10(1):321-343. doi: 10.1146/annurev-anchem-061516-045405. Epub 2017 Mar 6.
- Background: PubMed 16504283Carbone R, Marangi I, Zanardi A, Giorgetti L, Chierici E, Berlanda G, Podesta A, Fiorentini F, Bongiorno G, Piseri P, Pelicci PG, Milani P. Biocompatibility of cluster-assembled nanostructured TiO2 with primary and cancer cells. Biomaterials. 2006 Jun;27(17):3221-9. doi: 10.1016/j.biomaterials.2006.01.056. Epub 2006 Feb 28.
- Background: PubMed 20615202Zanardi A, Bandiera D, Bertolini F, Corsini CA, Gregato G, Milani P, Barborini E, Carbone R. Miniaturized FISH for screening of onco-hematological malignancies. Biotechniques. 2010 Jul;49(1):497-504. doi: 10.2144/000113445.
- Background: PubMed 33762721Krol I, Schwab FD, Carbone R, Ritter M, Picocci S, De Marni ML, Stepien G, Franchi GM, Zanardi A, Rissoglio MD, Covelli A, Guidi G, Scarinci D, Castro-Giner F, Mazzarella L, Doglioni C, Borghi F, Milani P, Kurzeder C, Weber WP, Aceto N. Detection of clustered circulating tumour cells in early breast cancer. Br J Cancer. 2021 Jul;125(1):23-27. doi: 10.1038/s41416-021-01327-8. Epub 2021 Mar 24.
- Background: PubMed 28819021Scher HI, Graf RP, Schreiber NA, McLaughlin B, Jendrisak A, Wang Y, Lee J, Greene S, Krupa R, Lu D, Bamford P, Louw JE, Dugan L, Vargas HA, Fleisher M, Landers M, Heller G, Dittamore R. Phenotypic Heterogeneity of Circulating Tumor Cells Informs Clinical Decisions between AR Signaling Inhibitors and Taxanes in Metastatic Prostate Cancer. Cancer Res. 2017 Oct 15;77(20):5687-5698. doi: 10.1158/0008-5472.CAN-17-1353. Epub 2017 Aug 17.
- Background: PubMed 29434968Xu L, Jia S, Li H, Yu Y, Liu G, Wu Y, Liu X, Liu C, Zhou Y, Zhang Z, Sheng Y. Characterization of circulating tumor cells in newly diagnosed breast cancer. Oncol Lett. 2018 Feb;15(2):2522-2528. doi: 10.3892/ol.2017.7540. Epub 2017 Dec 6.
- Background: PubMed 28814879Roviello G, Corona SP, Bonetta A, Cappelletti MR, Generali D. Circulating tumor cells correlate with patterns of recurrence in patients with hormone-sensitive prostate cancer. Onco Targets Ther. 2017 Jul 31;10:3811-3815. doi: 10.2147/OTT.S143020. eCollection 2017.
- Individual participant dataSharing planned: No. This is a basic research study without an IPD information sharing plan
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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.
Alberto Briganti, MD principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Tethis S.p.A. at 1 site 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers (time frame: day 1 : blood collection day). 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 NCT04964271, which also lists 8 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 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.