Telomere Associated Variables (TAVs) in Prostate Cancer

Completed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04124900

Run by

Life Length SL

People needed

509

Starts

2019-07-15

Expected to finish

2023-09-21

Last updated by the study team

2023-10-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

• Urological Research Network, Corp. — Hialeah, Florida, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• Hospital Infanta Margarita — Cabra, Córdoba, Spain
• Instituto Médico Tecnológico — Barcelona, Spain
• University Hospital Reina Sofía — Córdoba, Spain
• ROC Clinic — Madrid, Spain
• Instituto de Urología LYX — Madrid, Spain
• Hospital Universitario Ramón y Cajal — Madrid, Spain
• Hospital Universitario Doce de Octubre — Madrid, Spain
• Instituto Valenciano de Oncología — Valencia, Spain

Full record on ClinicalTrials.gov

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