Telomere Associated Variables (TAVs) in Prostate Cancer

NCT04124900 | Completed

• 1 other identifier: PROSTAV001
• Study Type: observational
• Target: 509
• Locations: 2 countries
• Sites: 10

Brief Summary

This research project results from the interest in continuing the collaboration with the previous LL-HURS-ONC001 clinical validation study, which gives cause to the present study. LL-HURS-ONC001 was carried out with the participation of HURS' Principal Investigator and the team of experts in prostate cancer, as well as with the participation of the Sponsor's scientific and development team, Life Length SL, led by Dr. Najarro. The main objective of this study is to demonstrate the efficacy of the PROSTAV test in cutting down on unnecessary biopsies in prostate cancer screening/early diagnosis. PROSTAV is a minimally invasive test, easy to implement as biomarker for prostate cancer diagnosis. The efficacy of the PROSTAV test is clinically validated by the results obtained in a previous study, LL-HURS-ONC001. The purpose of this study is to advance in the development of new biomarkers in areas where there is a clinical need and where the telomeric profile influences medical decisions within the patient's clinical context. The association level between each individual's telomere biology and the results of the prostate biopsy will be confirmed. Data will be collected to subsequently delve deeper into and accurately establish the effect of this measure in prostate cancer patient management to substantiate its implementation in standard care.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate biopsy; telomere; biomarker; screening; prostate; cancer; biopsy

Outcome Measures

Primary Outcomes (1)

• Telomere Associated Variables

  This is a clinical multicenter study focused on evaluating the efficacy of the PROSTAV test in patients at risk of prostate cancer based on data of telomere associated variables (TAV) as risk-score. The study comprises one single prospective observational phase.

  One day single measurement

Study Arms (1)

patients at prostate cancer risk diagnosed

The study is composed of one single subject cohort. After risk evaluation, prostate biopsies will be performed for diagnostic purposes on all recruited patients. The cases are sorted into two groups after diagnosis: * Group 1: patients at prostate cancer risk diagnosed with significant prostate cancer after prostatic biopsy (Gleason \>6). * Group 2: patients at prostate cancer risk diagnosed free of cancer after prostate biopsy. There will be a subdivision within this group in patients without significant prostate cancer ( No cancer o Non-significant prostate cancer (Gleason ≤6)).

Eligibility Criteria

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

Study Population

The study population will include cases with high PSA levels (PSA\<10 ng/ml) and with indication criterion for prostate cancer biopsy based on prostate cancer risk-related endpoints. The study is composed of one single subject cohort. After risk evaluation, prostate biopsies will be performed for diagnostic purposes on all recruited patients. The cases are sorted into two groups after diagnosis: * Group 1: patients at prostate cancer risk diagnosed with significant prostate cancer after prostatic biopsy (Gleason \>6). * Group 2: patients at prostate cancer risk diagnosed free of cancer after prostate biopsy. There will be a subdivision within this group in patients without significant prostate cancer: * No cancer * Non-significant prostate cancer (Gleason ≤6).

You may qualify if:

• To be over 18 years of age.
• To have given written consent to participate in the study.
• To be classified as a patient at prostate cancer risk according to criteria of high PSA levels (\<10 ng/ml) and the urologist's decision to perform a prostate biopsy in standard of care.
• To be diagnosed by a prostate biopsy with or without concomitant MRI.
• Caucasic race

You may not qualify if:

• Patients that have received Alpha-5 reductase therapy.
• Existing serious active liver, lung or kidney disease, as well as severe active infections.
• Existing serious disease or psychiatric disorder that prevents them from expressing informed consent and/or if patients are not able to follow protocol procedures and give their informed consent.
• Patients at risk resulting from conventional blood extraction.
• Subjects with active neoplasm diagnosed during the past five years.

Sponsors & Collaborators

• Life Length SL: lead

Study Sites (10)

Urological Research Network, Corp.

Hialeah, Florida, 33016, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Hospital Infanta Margarita

Cabra, Córdoba, 14940, Spain

Location

Instituto Médico Tecnológico

Barcelona, 08024, Spain

Location

University Hospital Reina Sofía

Córdoba, 14004, Spain

Location

ROC Clinic

Madrid, 28010, Spain

Location

Instituto de Urología LYX

Madrid, 28020, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Doce de Octubre

Madrid, 28041, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

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Related Links

• Requirements for Minimum Sample Size for Sensitivity and Specificity Analysis

Biospecimen

Retention: SAMPLES WITH DNA

PBMCs isolated from fresh blood samples

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria José Requena

  University Hospital Reina Sofía

  PRINCIPAL INVESTIGATOR

• Enrique Gómez, MD

  University Hospital Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: July 15, 2019
• Primary Completion: July 31, 2023
• Study Completion: September 21, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); US (2)