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

Prostatic Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04964271
• Other study ID #: TET-21-002
• Status: Recruiting
• Start date: September 9, 2021
• Est. completion date: July 2023

Study information

• Verified date: October 2022
• Source: Tethis S.p.A.
• Contact: Vito Cucchiara, MD
• Phone: +390226436923
• Email: cucchiara.vito[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Tethis S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Carbone R, Marangi I, Zanardi A, Giorgetti L, Chierici E, Berlanda G, Podestà 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. Epub 2006 Feb 28. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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