Measurement of Telomere Associated Variables (TAVs) for Diagnostic Purposes in Prostate Cancer

Status: Completed
Location: See all (10) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
View:

• 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

Locations
United States
Florida
Urological Research Network, Corp.
Hialeah
Texas
Houston Methodist Research Institute
Houston
Other Locations
Spain
Instituto Médico Tecnológico
Barcelona
Hospital Infanta Margarita
Cabra
University Hospital Reina Sofía
Córdoba
Hospital Universitario Doce de Octubre
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Instituto de Urología LYX
Madrid
ROC Clinic
Madrid
Instituto Valenciano de Oncología
Valencia
Time Frame
Start Date: 2019-07-15
Completion Date: 2023-09-21
Participants
Target number of participants: 509
Treatments
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)).
Authors
Related Therapeutic Areas
Sponsors
Leads: Life Length SL

This content was sourced from clinicaltrials.gov