Cancer of ProstateNCT06554587
Investigation of Three Biomarkers for the Detection of Prostate Cancer
An observational study of Cancer of Prostate, run by Medtechtomarket Consulting Ltd at 1 site in United Kingdom.
Trial summary
GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer of Prostate
- What is being tested?
- Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)
- How many people
- 137 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2025to 7 Aug 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Male patients referred to the secondary care (urology clinic) for transperineal biopsy for the investigation of suspected prostate cancer or patients undergoing active surveillance
Who may be able to join
- Male patients aged 18 years and over
- The patient is being investigated for suspected prostate cancer or is on active surveillance
- The patient is able to give consent to take part in the study
Who cannot join
- A patient who has already taken part in the study
- A patient with an active urinary tract infection
- The patient has a prior diagnosis of any other cancer or is receiving any cancer treatment (including ADT)
- The patient is currently or within the last 4 months enrolled on another study involving an investigational medicinal product
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, L7 8XP
About this study
Official title: Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer
GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. The purpose of this study is to further evaluate the sensitivity and specificity of the GlycoScore biomarkers for the detection of clinically significant prostate cancer. Sensitivity and specificity will be determined for each marker, combinations of the three markers and combinations of the GlycoScore biomarkers with PSA (prostate specific antigen). The results from this study will be used to identify the most suitable biomarker/biomarkers for use in developing a GlycoScore test.
This is a prospective, non-interventional study using venous blood samples taken from patients with suspected prostate cancer or on active surveillance, attending the hospital Urology department for a transperineal biopsy.
Read the detailed description
Worldwide, prostate cancer is the most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men. This amounted to 1,414,249 newly diagnosed cases and 375,000 deaths worldwide yearly from this disease in 2020. Globally, prostate cancer is the most commonly diagnosed cancer in more than fifty percent of countries (112 of 185). It presents a significant clinical burden in terms of volume and as a diagnostic challenge.
The initial diagnosis of prostate cancer relies on the detection of PSA (prostate specific antigen) in patient blood. While PSA is relatively good at identifying prostate cancer, PSA levels can be elevated for reasons other than cancer (giving a false positive result). Two thirds of men with a raised PSA level don't have prostate cancer meaning that many men undergo unnecessary \& invasive follow up procedures, such as tissue biopsy. Prostate biopsies place a huge burden on both healthcare systems, and individuals with suspected prostate cancer. They are painful, can lead to complications, infections and in extreme circumstances, death.
Therefore, the poor specificity of the PSA test, combined with the disparate natural histories of many prostate cancers has limited its utility as a screening tool.
A combination of clinical and pathological features, such as the tumour grade (Gleason score or Gleason Grade Group), combined with clinical examination (digital rectal examination), MRI (magnetic resonance imaging) and isotope bone scan are commonly used to determine the aggressiveness and curability of tumours with radical treatment. PSA measurement is used as part of this assessment but, as other factors can influence PSA levels, it cannot be used to assess risk or guide treatment in isolation.
There remains an unmet clinical need for a better screening and diagnostic test for prostate cancer. Such a test must also be able to differentiate between early, low-risk cancers that do not require radical treatment and more aggressive tumours where radical treatment is preferable. By identifying which patients have a clinically significant risk of prostate cancer we believe our test could provide a solution to both.
The GlycoScore immunoassays detect the three biomarkers - 'glycosyltransferase enzymes' in patient blood (GALNT7, ST6GAL1 and GCNT1) which are linked to key tumour-associated glycans (types of sugars on cell walls) using an ELISA (enzyme-linked immunosorbent assay-based platform).
Initial studies conducted by Newcastle University using RUO (research use only) ELISA kits showed a significant correlation between prostate cancer and the three biomarkers ST6GAL1, GCNT1 and GALNT7. Extensive research and development work has been carried out developing custom antibody pairs and antigens for inclusion in our ELISA kit, as well as to optimize buffers and other components.
The purpose of this study is to obtain fresh patient blood samples to further evaluate the three biomarkers ST6GAL1, GCNT1 and GALNT7 for their ability to identify clinically significant prostate cancer, either alone, as a combination of the biomarkers or in combination with the PSA (measurement obtained at Medtechtomarket) using our in-house developed ELISA assays and a CE-marked PSA ELISA test kit.
Diagnostic accuracy for participants with prostate cancer will be determined by comparison with biopsy results, and for participants without prostate cancer, comparison with mpMRI (multi-parametric magnetic resonance imaging) and biopsy results.
Assessment of the correlation between the GlycoScore biomarker results with the full range of biopsy Gleason scores/Gleason Grade group/CPG grade (Cambridge Prognostic Group) will allow an assessment of the prognostic value of the GlycoScore test and its potential use in the clinical management of prostate cancer.
Patients attending the hospital for a transperineal prostate biopsy who are either being investigated for suspected prostate cancer or are undergoing active surveillance for previously diagnosed prostate cancer will be asked to consent to take part in the study. Patients will be asked to consent to have a small sample of blood taken before the biopsy and for study investigators to have access to their final diagnosis. The blood sample will be sent to Medtechtomarket Laboratories for measurement of the biomarkers and PSA. Patients will also be asked to consent to an additional tube of blood to be taken (from the same blood draw) and the urine sample, which is routinely taken before the biopsy to be sent to the Liverpool University Biobank for future use in research studies.
137 male patients aged 18 years and above will be recruited for the study which is expected to take 12 months.
- Conditions
- Cancer of Prostate
- Being tested
- Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)Diagnostic test
Measurement of the plasma concentration of ST6GAL1, GCNT1 and GALNT7 biomarkers in patients suspected of having prostate cancer or on active surveillance
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected prostate cancer or on active surveillance | Diagnostic tests to measure three separate biomarkers in blood taken from patients pre-biopsy to assess the diagnostic performance of the biomarkers in detecting clinically significant prostate cancer (Gleason score ≥7) Receives: Diagnostic Test: Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
An evaluation of the diagnostic performance of the GlycoScore biomarkers for the detection of clinically significant prostate cancer (Gleason score of ≥7).
A comparison of calculated sensitivity, specificity and positive and negative predictive values for clinically significant prostate cancer for the following:
Each biomarker, alone and in combination with PSA (measured on from the same blood sample using a CE-marked assay)
Each possible combination of GlycoScore biomarkers, alone and in combination with PSA
The reference method for diagnosis of prostate cancer will be biopsy, and the reference method for identifying patients who do not have cancer will be by a combination of mpMRI and/or biopsy.
Measured: Pre-biopsy (one time point)
Secondary outcomes (4)
Establishment of a 'GlycoScore' algorithm
Establish an algorithm for calculating a 'GlycoScore' that converts the assay results from the optimal combination of biomarkers into a score that indicates the likelihood that a patient has clinically significant prostate cancer (Gleason score of ≥7).
Measured: Pre-biopsy (one time point)
An evaluation of the ability of the calculated 'GlycoScore' to distinguish between individual Gleason scores and grade groups
Correlation between the calculated 'GlycoScore' from each sample and Gleason score and grade groups at biopsy
Measured: Pre-biopsy (one time point)
An evaluation of the ability of the calculated 'GlycoScore' to distinguish between CPG groups 1 to 5 (Cambridge Prognostic Group classification)
Correlation between the calculated 'GlycoScore' from each sample and the Cambridge Prognostic Group classification
Measured: Pre-biopsy (one time point)
A comparison of the diagnostic performance of the GlycoScore biomarkers (with and without PSA) against the performance of the hospital PSA test alone for the detection of clinically significant prostate cancer (Gleason score of ≥7).
A comparison of calculated sensitivity, specificity and positive and negative predictive values for clinically significant prostate cancer
Measured: Pre-biopsy (one time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start7 Jan 2025
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer of ProstateStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtechtomarket Consulting Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlycoscoreDx Ltd
- Responsible party
- Sponsor
- Investigators
- Henry P Lazarowicz, FRCS(Urol), Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554587
- Sponsor's protocol ID
- M2M-GLYCOSCORE-01
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roddam AW, Duffy MJ, Hamdy FC, Ward AM, Patnick J, Price CP, Rimmer J, Sturgeon C, White P, Allen NE; NHS Prostate Cancer Risk Management Programme. Use of prostate-specific antigen (PSA) isoforms for the detection of prostate cancer in men with a PSA level of 2-10 ng/ml: systematic review and meta-analysis. Eur Urol. 2005 Sep;48(3):386-99; discussion 398-9. doi: 10.1016/j.eururo.2005.04.015.
PubMed 15982797Catalona WJ, Hudson MA, Scardino PT, Richie JP, Ahmann FR, Flanigan RC, DeKernion JB, Ratliff TL, Kavoussi LR, Dalkin BL, Waters WB, MacFarlane MT, Southwick PC. Selection of optimal prostate specific antigen cutoffs for early detection of prostate cancer: receiver operating characteristic curves. J Urol. 1994 Dec;152(6 Pt 1):2037-42. doi: 10.1016/s0022-5347(17)32300-5.
PubMed 7525995Johnston E, Pye H, Bonet-Carne E, Panagiotaki E, Patel D, Galazi M, Heavey S, Carmona L, Freeman A, Trevisan G, Allen C, Kirkham A, Burling K, Stevens N, Hawkes D, Emberton M, Moore C, Ahmed HU, Atkinson D, Rodriguez-Justo M, Ng T, Alexander D, Whitaker H, Punwani S. INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted magnetic resonance imaging for the prediction and characterization of prostate cancer. BMC Cancer. 2016 Oct 21;16(1):816. doi: 10.1186/s12885-016-2856-2.
PubMed 27769214Tuck MK, Chan DW, Chia D, Godwin AK, Grizzle WE, Krueger KE, Rom W, Sanda M, Sorbara L, Stass S, Wang W, Brenner DE. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res. 2009 Jan;8(1):113-7. doi: 10.1021/pr800545q.
PubMed 19072545Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol. 2005 Aug;58(8):859-62. doi: 10.1016/j.jclinepi.2004.12.009.
PubMed 16018921
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of the Glycoscore Biomarkers for the Detection of Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06554587
- Acronym / sponsor ID
- M2M-GLYCOSCORE-01
- Conditions
- Cancer of Prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Medtechtomarket Consulting LtdIndustry (pharma, biotech, devices)
- Collaborators
- GlycoscoreDx Ltd
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 15 Aug 2024 (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.
GlycoScore Dx Limited, a diagnostics company based in the United Kingdom have identified three glycoproteins, that showed promise as biomarkers of prostate cancer in initial validation studies. The purpose of this study is to further evaluate the sensitivity and specificity of the GlycoScore biomarkers for the detection of clinically significant prostate cancer. Sensitivity and specificity will be determined for each marker, combinations of the three markers and combinations of the GlycoScore biomarkers with PSA (prostate specific antigen). The results from this study will be used to identify the most suitable biomarker/biomarkers for use in developing a GlycoScore test.
This is a prospective, non-interventional study using venous blood samples taken from patients with suspected prostate cancer or on active surveillance, attending the hospital Urology department for a transperineal biopsy.
Detailed description
Worldwide, prostate cancer is the most commonly diagnosed cancer in men and the fifth leading cause of cancer death in men. This amounted to 1,414,249 newly diagnosed cases and 375,000 deaths worldwide yearly from this disease in 2020. Globally, prostate cancer is the most commonly diagnosed cancer in more than fifty percent of countries (112 of 185). It presents a significant clinical burden in terms of volume and as a diagnostic challenge.
The initial diagnosis of prostate cancer relies on the detection of PSA (prostate specific antigen) in patient blood. While PSA is relatively good at identifying prostate cancer, PSA levels can be elevated for reasons other than cancer (giving a false positive result). Two thirds of men with a raised PSA level don't have prostate cancer meaning that many men undergo unnecessary \& invasive follow up procedures, such as tissue biopsy. Prostate biopsies place a huge burden on both healthcare systems, and individuals with suspected prostate cancer. They are painful, can lead to complications, infections and in extreme circumstances, death.
Therefore, the poor specificity of the PSA test, combined with the disparate natural histories of many prostate cancers has limited its utility as a screening tool.
A combination of clinical and pathological features, such as the tumour grade (Gleason score or Gleason Grade Group), combined with clinical examination (digital rectal examination), MRI (magnetic resonance imaging) and isotope bone scan are commonly used to determine the aggressiveness and curability of tumours with radical treatment. PSA measurement is used as part of this assessment but, as other factors can influence PSA levels, it cannot be used to assess risk or guide treatment in isolation.
There remains an unmet clinical need for a better screening and diagnostic test for prostate cancer. Such a test must also be able to differentiate between early, low-risk cancers that do not require radical treatment and more aggressive tumours where radical treatment is preferable. By identifying which patients have a clinically significant risk of prostate cancer we believe our test could provide a solution to both.
The GlycoScore immunoassays detect the three biomarkers - 'glycosyltransferase enzymes' in patient blood (GALNT7, ST6GAL1 and GCNT1) which are linked to key tumour-associated glycans (types of sugars on cell walls) using an ELISA (enzyme-linked immunosorbent assay-based platform).
Initial studies conducted by Newcastle University using RUO (research use only) ELISA kits showed a significant correlation between prostate cancer and the three biomarkers ST6GAL1, GCNT1 and GALNT7. Extensive research and development work has been carried out developing custom antibody pairs and antigens for inclusion in our ELISA kit, as well as to optimize buffers and other components.
The purpose of this study is to obtain fresh patient blood samples to further evaluate the three biomarkers ST6GAL1, GCNT1 and GALNT7 for their ability to identify clinically significant prostate cancer, either alone, as a combination of the biomarkers or in combination with the PSA (measurement obtained at Medtechtomarket) using our in-house developed ELISA assays and a CE-marked PSA ELISA test kit.
Diagnostic accuracy for participants with prostate cancer will be determined by comparison with biopsy results, and for participants without prostate cancer, comparison with mpMRI (multi-parametric magnetic resonance imaging) and biopsy results.
Assessment of the correlation between the GlycoScore biomarker results with the full range of biopsy Gleason scores/Gleason Grade group/CPG grade (Cambridge Prognostic Group) will allow an assessment of the prognostic value of the GlycoScore test and its potential use in the clinical management of prostate cancer.
Patients attending the hospital for a transperineal prostate biopsy who are either being investigated for suspected prostate cancer or are undergoing active surveillance for previously diagnosed prostate cancer will be asked to consent to take part in the study. Patients will be asked to consent to have a small sample of blood taken before the biopsy and for study investigators to have access to their final diagnosis. The blood sample will be sent to Medtechtomarket Laboratories for measurement of the biomarkers and PSA. Patients will also be asked to consent to an additional tube of blood to be taken (from the same blood draw) and the urine sample, which is routinely taken before the biopsy to be sent to the Liverpool University Biobank for future use in research studies.
137 male patients aged 18 years and above will be recruited for the study which is expected to take 12 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected prostate cancer or on active surveillance | – | Diagnostic Test: Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)Diagnostic tests to measure three separate biomarkers in blood taken from patients pre-biopsy to assess the diagnostic performance of the biomarkers in detecting clinically significant prostate cancer (Gleason score ≥7) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients referred to the secondary care (urology clinic) for transperineal biopsy for the investigation of suspected prostate cancer or patients undergoing active surveillance
Key inclusion criteria (3 listed)
- Male patients aged 18 years and over
- The patient is being investigated for suspected prostate cancer or is on active surveillance
- The patient is able to give consent to take part in the study
Key exclusion criteria (4 listed)
- A patient who has already taken part in the study
- A patient with an active urinary tract infection
- The patient has a prior diagnosis of any other cancer or is receiving any cancer treatment (including ADT)
- The patient is currently or within the last 4 months enrolled on another study involving an investigational medicinal product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)Measurement of the plasma concentration of ST6GAL1, GCNT1 and GALNT7 biomarkers in patients suspected of having prostate cancer or on active surveillance | Diagnostic test | Patients with suspected prostate cancer or on active surveillance |
Primary outcome
An evaluation of the diagnostic performance of the GlycoScore biomarkers for the detection of clinically significant prostate cancer (Gleason score of ≥7).
Time frame: Pre-biopsy (one time point)
A comparison of calculated sensitivity, specificity and positive and negative predictive values for clinically significant prostate cancer for the following: Each biomarker, alone and in combination with PSA (measured on from the same blood sample using a CE-marked assay) Each possible combination of GlycoScore biomarkers, alone and in combination with PSA The reference method for diagnosis of prostate cancer will be biopsy, and the reference method for identifying patients who do not have cancer will be by a combination of mpMRI and/or biopsy.
4 secondary outcomes
Establishment of a 'GlycoScore' algorithm
Time frame: Pre-biopsy (one time point)
An evaluation of the ability of the calculated 'GlycoScore' to distinguish between individual Gleason scores and grade groups
Time frame: Pre-biopsy (one time point)
An evaluation of the ability of the calculated 'GlycoScore' to distinguish between CPG groups 1 to 5 (Cambridge Prognostic Group classification)
Time frame: Pre-biopsy (one time point)
A comparison of the diagnostic performance of the GlycoScore biomarkers (with and without PSA) against the performance of the hospital PSA test alone for the detection of clinically significant prostate cancer (Gleason score of ≥7).
Time frame: Pre-biopsy (one time point)
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 9 Oct 2026.
- Background: PubMed 15982797Roddam AW, Duffy MJ, Hamdy FC, Ward AM, Patnick J, Price CP, Rimmer J, Sturgeon C, White P, Allen NE; NHS Prostate Cancer Risk Management Programme. Use of prostate-specific antigen (PSA) isoforms for the detection of prostate cancer in men with a PSA level of 2-10 ng/ml: systematic review and meta-analysis. Eur Urol. 2005 Sep;48(3):386-99; discussion 398-9. doi: 10.1016/j.eururo.2005.04.015.
- Background: PubMed 7525995Catalona WJ, Hudson MA, Scardino PT, Richie JP, Ahmann FR, Flanigan RC, DeKernion JB, Ratliff TL, Kavoussi LR, Dalkin BL, Waters WB, MacFarlane MT, Southwick PC. Selection of optimal prostate specific antigen cutoffs for early detection of prostate cancer: receiver operating characteristic curves. J Urol. 1994 Dec;152(6 Pt 1):2037-42. doi: 10.1016/s0022-5347(17)32300-5.
- Background: PubMed 27769214Johnston E, Pye H, Bonet-Carne E, Panagiotaki E, Patel D, Galazi M, Heavey S, Carmona L, Freeman A, Trevisan G, Allen C, Kirkham A, Burling K, Stevens N, Hawkes D, Emberton M, Moore C, Ahmed HU, Atkinson D, Rodriguez-Justo M, Ng T, Alexander D, Whitaker H, Punwani S. INNOVATE: A prospective cohort study combining serum and urinary biomarkers with novel diffusion-weighted magnetic resonance imaging for the prediction and characterization of prostate cancer. BMC Cancer. 2016 Oct 21;16(1):816. doi: 10.1186/s12885-016-2856-2.
- Background: PubMed 19072545Tuck MK, Chan DW, Chia D, Godwin AK, Grizzle WE, Krueger KE, Rom W, Sanda M, Sorbara L, Stass S, Wang W, Brenner DE. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res. 2009 Jan;8(1):113-7. doi: 10.1021/pr800545q.
- Background: PubMed 16018921Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol. 2005 Aug;58(8):859-62. doi: 10.1016/j.jclinepi.2004.12.009.
- Prostate cancer: diagnosis and management - current UK NICE guidelinesLink provided by the sponsor.
- Current NICE guidelines - Evidence review covering the definition of clinically significant prostate cancer, page 17Link 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.
Henry P Lazarowicz, FRCS(Urol) principal investigator
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Prostate, run by Medtechtomarket Consulting Ltd at 1 site in United Kingdom.
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 3 inclusion and 4 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
An evaluation of the diagnostic performance of the GlycoScore biomarkers for the detection of clinically significant prostate cancer (Gleason score of ≥7). (time frame: Pre-biopsy (one time point)). 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 NCT06554587, which also lists 5 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 9 Oct 2026.