Prostate CancerNCT04124900
Telomere Associated Variables (TAVs) in Prostate Cancer
An observational study of Prostate Cancer, run by Life Length SL at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 509 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Jul 2019to 21 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Spain8 sites
Instituto Médico Tecnológico
Barcelona, 08024
Hospital Infanta Margarita
Cabra, Córdoba, 14940
University Hospital Reina Sofía
Córdoba, 14004
ROC Clinic
Madrid, 28010
Instituto de Urología LYX
Madrid, 28020
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Doce de Octubre
Madrid, 28041
Instituto Valenciano de Oncología
Valencia, 46009
United States2 sites
Urological Research Network, Corp.
Hialeah, Florida, 33016
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
Official title: Measurement of Telomere Associated Variables (TAVs) for Diagnostic Purposes in Prostate Cancer
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.
Read the 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. However, some medical advisors of the sponsor stated that sometimes patients with PSA levels<3 are also diagnosed with prostate cancer. For this reason, it has been decided to remove the lower limit of PSA as inclusion criteria.
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.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate biopsy, telomere, biomarker, screening, prostate, cancer, biopsy
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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)). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day single measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start15 Jul 2019
- Primary completion31 Jul 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Length SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria José Requena, Principal investigator, University Hospital Reina SofíaEnrique Gómez, MD, Principal investigator, University Hospital Reina Sofía
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124900
- Sponsor's protocol ID
- PROSTAV001
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000 Jan 7;100(1):57-70. doi: 10.1016/s0092-8674(00)81683-9. No abstract available.
PubMed 10647931Shay JW, Wright WE, Werbin H. Defining the molecular mechanisms of human cell immortalization. Biochim Biophys Acta. 1991 Apr 16;1072(1):1-7. doi: 10.1016/0304-419x(91)90003-4.
PubMed 1850299Hahn WC, Counter CM, Lundberg AS, Beijersbergen RL, Brooks MW, Weinberg RA. Creation of human tumour cells with defined genetic elements. Nature. 1999 Jul 29;400(6743):464-8. doi: 10.1038/22780.
PubMed 10440377Wright 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.
PubMed 10932210Shay JW, Zou Y, Hiyama E, Wright WE. Telomerase and cancer. Hum Mol Genet. 2001 Apr;10(7):677-85. doi: 10.1093/hmg/10.7.677.
PubMed 11257099Kim 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.
PubMed 7605428Shay 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.
PubMed 9282118Breslow 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.
PubMed 9150185Shay JW. Telomerase in cancer: diagnostic, prognostic, and therapeutic implications. Cancer J Sci Am. 1998 May;4 Suppl 1:S26-34. No abstract available.
PubMed 9619268Norton JC, Holt SE, Wright WE, Shay JW. Enhanced detection of human telomerase activity. DNA Cell Biol. 1998 Mar;17(3):217-9. doi: 10.1089/dna.1998.17.217.
PubMed 9539101Hiyama E, Hiyama K, Yokoyama T, Matsuura Y, Piatyszek MA, Shay JW. Correlating telomerase activity levels with human neuroblastoma outcomes. Nat Med. 1995 Mar;1(3):249-55. doi: 10.1038/nm0395-249.
PubMed 7585042Sommerfeld HJ, Meeker AK, Piatyszek MA, Bova GS, Shay JW, Coffey DS. Telomerase activity: a prevalent marker of malignant human prostate tissue. Cancer Res. 1996 Jan 1;56(1):218-22.
PubMed 8548767Mehle C, Piatyszek MA, Ljungberg B, Shay JW, Roos G. Telomerase activity in human renal cell carcinoma. Oncogene. 1996 Jul 4;13(1):161-6.
PubMed 8700542Tatsumoto N, Hiyama E, Murakami Y, Imamura Y, Shay JW, Matsuura Y, Yokoyama T. High telomerase activity is an independent prognostic indicator of poor outcome in colorectal cancer. Clin Cancer Res. 2000 Jul;6(7):2696-701.
PubMed 10914712Shay JW, Gazdar AF. Telomerase in the early detection of cancer. J Clin Pathol. 1997 Feb;50(2):106-9. doi: 10.1136/jcp.50.2.106.
PubMed 9155689
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Telomere Associated Variables (TAVs) for Diagnostic Purposes in Prostate Cancer
- ClinicalTrials.gov ID
- NCT04124900
- Acronym / sponsor ID
- PROSTAV001
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate biopsy, telomere, biomarker, screening, prostate, cancer, biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Life Length SLIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. However, some medical advisors of the sponsor stated that sometimes patients with PSA levels<3 are also diagnosed with prostate cancer. For this reason, it has been decided to remove the lower limit of PSA as inclusion criteria.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Background: PubMed 10647931Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000 Jan 7;100(1):57-70. doi: 10.1016/s0092-8674(00)81683-9. No abstract available.
- Background: PubMed 1850299Shay JW, Wright WE, Werbin H. Defining the molecular mechanisms of human cell immortalization. Biochim Biophys Acta. 1991 Apr 16;1072(1):1-7. doi: 10.1016/0304-419x(91)90003-4.
- Background: PubMed 10440377Hahn WC, Counter CM, Lundberg AS, Beijersbergen RL, Brooks MW, Weinberg RA. Creation of human tumour cells with defined genetic elements. Nature. 1999 Jul 29;400(6743):464-8. doi: 10.1038/22780.
- Background: PubMed 10932210Wright 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.
- Background: PubMed 11257099Shay JW, Zou Y, Hiyama E, Wright WE. Telomerase and cancer. Hum Mol Genet. 2001 Apr;10(7):677-85. doi: 10.1093/hmg/10.7.677.
- Background: PubMed 7605428Kim 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.
- Background: PubMed 9282118Shay 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.
- Background: PubMed 9150185Breslow 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.
- Background: PubMed 9619268Shay JW. Telomerase in cancer: diagnostic, prognostic, and therapeutic implications. Cancer J Sci Am. 1998 May;4 Suppl 1:S26-34. No abstract available.
- Background: PubMed 9539101Norton JC, Holt SE, Wright WE, Shay JW. Enhanced detection of human telomerase activity. DNA Cell Biol. 1998 Mar;17(3):217-9. doi: 10.1089/dna.1998.17.217.
- Background: PubMed 7585042Hiyama E, Hiyama K, Yokoyama T, Matsuura Y, Piatyszek MA, Shay JW. Correlating telomerase activity levels with human neuroblastoma outcomes. Nat Med. 1995 Mar;1(3):249-55. doi: 10.1038/nm0395-249.
- Background: PubMed 8548767Sommerfeld HJ, Meeker AK, Piatyszek MA, Bova GS, Shay JW, Coffey DS. Telomerase activity: a prevalent marker of malignant human prostate tissue. Cancer Res. 1996 Jan 1;56(1):218-22.
- Requirements for Minimum Sample Size for Sensitivity and Specificity AnalysisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria José Requena principal investigator
University Hospital Reina Sofía
Enrique Gómez, MD principal investigator
University Hospital Reina Sofía
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Life Length SL at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere Associated Variables (time frame: One day single measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124900, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.