Investigation of Three Biomarkers for the Detection of Prostate Cancer

NCT06554587 | Recruiting

• 1 other identifier: M2M-GLYCOSCORE-01
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cancer of Prostate

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-biopsy (one time point)

Secondary Outcomes (4)

• Establishment of a 'GlycoScore' algorithm

  Pre-biopsy (one time point)

• An evaluation of the ability of the calculated 'GlycoScore' to distinguish between individual Gleason scores and grade groups

  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)

  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).

  Pre-biopsy (one time point)

Study Arms (1)

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)

Diagnostic Test: Laboratory Biomarker Analysis: Enzyme-linked immunosorbent assay (ELISA)

Interventions

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

Patients with suspected prostate cancer or on active surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtechtomarket Consulting Ltd: lead
• GlycoscoreDx Ltd: collaborator

Study Sites (1)

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

RECRUITING

Related Publications (5)

• 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.

  PMID: 15982797 BACKGROUND

• Catalona 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.

  PMID: 7525995 BACKGROUND

• Johnston 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.

  PMID: 27769214 BACKGROUND

• Tuck 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.

  PMID: 19072545 BACKGROUND

• Flahault 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.

  PMID: 16018921 BACKGROUND

Related Links

• Prostate cancer: diagnosis and management - current UK NICE guidelines
• Current NICE guidelines - Evidence review covering the definition of clinically significant prostate cancer, page 17

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples retained from consenting patients

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Henry P Lazarowicz, FRCS(Urol)

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Newman, BSc

CONTACT

07595 298 248; rebecca.newman@medtechtomarket.com

Lindsay Traynor, BSc

CONTACT

lindsay.traynor@medtechtomarket.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: January 7, 2025
• Primary Completion: January 7, 2026
• Study Completion: March 7, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)