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Telomere Associated Variables (TAVs) in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04124900
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Life Length SL

Tracking Information
First Submitted Date October 10, 2019
First Posted Date October 14, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date July 15, 2019
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2019)
Telomere Associated Variables [ Time Frame: One day single measurement ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04124900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Telomere Associated Variables (TAVs) in Prostate Cancer
Official Title Measurement of Telomere Associated Variables (TAVs) for Diagnostic Purposes in Prostate Cancer
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.

Detailed Description

In this study, patient inclusion and sample collection are multicentric. Sample analysis will be carried out at Life Length's laboratories at the Madrid Science Park in Canto Blanco university campus.

The study will be initiated immediately after approval by the IRB and has an overall length of 12 months (recruiting time).

The main purpose of the present study is to determine the efficacy of the PROSTAV test as a prostate cancer biomarker developed by Life Length and which has been subject to internal validation in a previous study (LL-HURS-ONC001). For this purpose, the risk-prediction algorithm based on telomere and clinical variables will be used. This allows to back medical decisions in patients with uncertain PC diagnosis based on their PSA levels and the need to perform a prostate biopsy. The standard of care of the participating hospitals and following the European Urology Association recommendations, patients with PSA >3 (prostate-specific antigen) and/or positive digital rectal examination (DRE) are considered at risk for developing PC.

This study includes only one group of patients defined by inclusion criteria and who will be classified in different groups after a biopsy is performed: 1) patients with a positive biopsy result (diagnosed with significant prostate cancer) (Gleason score >6), and without significant prostate cancer (Gleason score ≤6) or no cancer. Before knowing the histopathological results of the biopsy, the PROSTAV test will be performed. Depending on the results of the PROSTAV test, the physician will write down which decision he or she would have made as to performing or not a biopsy: zero (0) for a low-risk result in the PROSTAV test, in which case no biopsy would have been performed; and one (1) for a PC risk result in the PROSTAV test, in which case a biopsy would have been performed. Regardless of what the result of the PROSTAV test is, all patients will undergo a biopsy since the result in PROSTAV test will not influence the standard of care in this study.

A 10 ml. sample is required from all subjects included in the study for telomere analysis. This sample is obtained from blood drawn before performing the diagnostic prostate biopsy. The sample must be drawn within a 90-day period prior to biopsy.

The design of the present project allows for one single study phase. This study is a clinical efficacy validation study in patients in whom the results of potential biopsy sparing are compared after evaluating medical decisions based on the use of the PROSTAV test.

The point of origin of the samples are the different participating centers that will use the samples for application of the telomere biology evaluation techniques.

Mononuclear cells in peripheral blood from all samples will be isolated and analyzed to determine values of Telomere Associated Variables (TAVs).

For the calculation of the telomere variables, the Sponsor will use the High-Throughput Quantitative Fluorescent in Situ Hybridization technique (HT-Q-FISH).

Data resulting from each biological sample will be analyzed to obtain a defined risk assessment based on the algorithm of the PROSTAV test. The purpose of the analysis is the integration of the data resulting from telomere measurements (average, median, percentage of short telomeres, ratio of short and long telomeres, etc.) and PSA and free PSA levels, age and the DRE results of the patient's medical record to determine whether they are low-risk patients, in which a biopsy would not be necessary to confirm presence of prostate cancer. By doing this, it is intending to demonstrate the efficacy of the PROSTAV test, since biopsies would be performed in any case and also show the test's sensitivity and specificity values in clinical practice.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
PBMCs isolated from fresh blood samples
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).
Condition Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts 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)).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 11, 2019)
535
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 15, 2020
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Exclusion Criteria:

  • Patients who have undergone a previous biopsy.
  • 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Pilar Najarro +(34) 917378483 prostav@lifelength.com
Listed Location Countries Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04124900
Other Study ID Numbers PROSTAV001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Life Length SL
Study Sponsor Life Length SL
Collaborators Not Provided
Investigators
Principal Investigator: Maria José Requena University Hospital Reina Sofía
PRS Account Life Length SL
Verification Date October 2019