Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants

NCT04964271 | Active Not Recruiting

• 1 other identifier: TET-21-002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Neoplasms

Keywords

prostate cancer biomarker; circulating tumoral cell; immunofluorescence assay; prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of commercial Antibodies capable of identify specific Prostate Cancer Biomarkers

  Qualitative assessment of Staining Positivity for different Prostate Cancer Biomarkers

  day 1 : blood collection day

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be selected from among the people who visit the urology department

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tethis S.p.A.: lead

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

Location

Related Publications (8)

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  PMID: 29441349 BACKGROUND

• Rawal 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.

  PMID: 28301753 BACKGROUND

• Carbone 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.

  PMID: 16504283 BACKGROUND

• Zanardi 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.

  PMID: 20615202 BACKGROUND

• Krol 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.

  PMID: 33762721 BACKGROUND

• Scher 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.

  PMID: 28819021 BACKGROUND

• Xu 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.

  PMID: 29434968 BACKGROUND

• Roviello 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.

  PMID: 28814879 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alberto Briganti, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: September 9, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)