Clinical trial · Observational
Telomere Associated Variables (TAVs) in Prostate Cancer
Measurement of Telomere Associated Variables (TAVs) for Diagnostic Purposes in Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- patients at prostate cancer risk diagnosed
- description
- 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)).
Primary outcomes (1)
- measure
- Telomere Associated Variables
- timeFrame
- One day single measurement
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (20)
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- BACKGROUNDWright WE, Shay JW. Telomere dynamics in cancer progression and prevention: fundamental differences in human and mouse telomere biology. Nat Med. 2000 Aug;6(8):849-51. doi: 10.1038/78592. PMID 10932210
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- BACKGROUNDKim NW, Piatyszek MA, Prowse KR, Harley CB, West MD, Ho PL, Coviello GM, Wright WE, Weinrich SL, Shay JW. Specific association of human telomerase activity with immortal cells and cancer. Science. 1994 Dec 23;266(5193):2011-5. doi: 10.1126/science.7605428. PMID 7605428
- BACKGROUNDShay JW, Bacchetti S. A survey of telomerase activity in human cancer. Eur J Cancer. 1997 Apr;33(5):787-91. doi: 10.1016/S0959-8049(97)00062-2. PMID 9282118
- BACKGROUNDBreslow RA, Shay JW, Gazdar AF, Srivastava S. Telomerase and early detection of cancer: a National Cancer Institute workshop. J Natl Cancer Inst. 1997 May 7;89(9):618-23. doi: 10.1093/jnci/89.9.618. No abstract available.