Predicting Prostate Biopsy Results With Biomarkers and mpMRI.

NCT03730324 | Completed

• 1 other identifier: S-20170043
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement. In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies.

Conditions

Prostate Cancer

Keywords

Biomarkers; Magnetic Resonance Imaging; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Detection of clinical significant cancer.

  Positive biopsies with a Gleason grade \> 7.

  1 month

Secondary Outcomes (1)

• Detection rate of any cancers

  1 month

Other Outcomes (1)

• Change in Health Related Quality of Life

  Baseline, 24 hour, 1 month and 12 months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Study subject will undergo sampling of plasma and urine biomarkers.

Diagnostic Test: Urine and plasma biomarkes.

Magnetic Resonance Imaging.

EXPERIMENTAL

Prior to biopsies a magnetic resonance imaging scan will be performed.

Diagnostic Test: mpMRI; Diagnostic Test: Urine and plasma biomarkes.

Interventions

mpMRI DIAGNOSTIC_TEST

Study subjects will undergo urine and plasma biomarker testing and mpMRI prior to biopsy

Magnetic Resonance Imaging.

Urine and plasma biomarkes. DIAGNOSTIC_TEST

Study subjects will undergo urine and plasma biomarker testing prior to standard biopsy

Magnetic Resonance Imaging.; Standard care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Patients will require a prostate, so genotypic gender is a requirement.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed written consent.
• PSA \< 20.
• Referred for prostate biopsy.

You may not qualify if:

• Previously diagnosed with prostate cancer.
• Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies.
• Previously undergone prostate biopsies.
• Inability to undergo mpMRI scan (pacemaker , claustrophobia, impaired renal function, allergy towards contrast agent etc)
• Any, previous or current, therapy for benign prostate hyperplasia including surgery or medical therapy (except alpha adrenal blockers).
• They withdraw their consent.

Sponsors & Collaborators

• Torben Brøchner Pedersen: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (11)

• Nye kræfttilfælde Tabel [Internet]. Danish Cancer Registry - eSundhed. 2016

  BACKGROUND

• Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593.

  PMID: 24597866 BACKGROUND

• Mottet N, Bellmunt J, Bolla M, Briers E, Cumberbatch MG, De Santis M, Fossati N, Gross T, Henry AM, Joniau S, Lam TB, Mason MD, Matveev VB, Moldovan PC, van den Bergh RCN, Van den Broeck T, van der Poel HG, van der Kwast TH, Rouviere O, Schoots IG, Wiegel T, Cornford P. EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017 Apr;71(4):618-629. doi: 10.1016/j.eururo.2016.08.003. Epub 2016 Aug 25.

  PMID: 27568654 BACKGROUND

• Pelzer AE, Bektic J, Berger AP, Halpern EJ, Koppelstatter F, Klauser A, Rehder P, Horninger W, Bartsch G, Frauscher F. Are transition zone biopsies still necessary to improve prostate cancer detection? Results from the tyrol screening project. Eur Urol. 2005 Dec;48(6):916-21; discussion 921. doi: 10.1016/j.eururo.2005.07.012. Epub 2005 Aug 10.

  PMID: 16126324 BACKGROUND

• Stamey TA, Yang N, Hay AR, McNeal JE, Freiha FS, Redwine E. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med. 1987 Oct 8;317(15):909-16. doi: 10.1056/NEJM198710083171501.

  PMID: 2442609 BACKGROUND

• Albitar M, Ma W, Lund L, Albitar F, Diep K, Fritsche HA, Shore N. Predicting Prostate Biopsy Results Using a Panel of Plasma and Urine Biomarkers Combined in a Scoring System. J Cancer. 2016 Feb 2;7(3):297-303. doi: 10.7150/jca.12771. eCollection 2016.

  PMID: 26918043 BACKGROUND

• Panebianco V, Barchetti F, Sciarra A, Ciardi A, Indino EL, Papalia R, Gallucci M, Tombolini V, Gentile V, Catalano C. Multiparametric magnetic resonance imaging vs. standard care in men being evaluated for prostate cancer: a randomized study. Urol Oncol. 2015 Jan;33(1):17.e1-17.e7. doi: 10.1016/j.urolonc.2014.09.013. Epub 2014 Nov 11.

  PMID: 25443268 BACKGROUND

• Turkbey B, Pinto PA, Mani H, Bernardo M, Pang Y, McKinney YL, Khurana K, Ravizzini GC, Albert PS, Merino MJ, Choyke PL. Prostate cancer: value of multiparametric MR imaging at 3 T for detection--histopathologic correlation. Radiology. 2010 Apr;255(1):89-99. doi: 10.1148/radiol.09090475.

  PMID: 20308447 BACKGROUND

• Boesen L, Noergaard N, Chabanova E, Logager V, Balslev I, Mikines K, Thomsen HS. Early experience with multiparametric magnetic resonance imaging-targeted biopsies under visual transrectal ultrasound guidance in patients suspicious for prostate cancer undergoing repeated biopsy. Scand J Urol. 2015 Feb;49(1):25-34. doi: 10.3109/21681805.2014.925497. Epub 2014 Jun 12.

  PMID: 24922550 BACKGROUND

• Filson CP, Natarajan S, Margolis DJ, Huang J, Lieu P, Dorey FJ, Reiter RE, Marks LS. Prostate cancer detection with magnetic resonance-ultrasound fusion biopsy: The role of systematic and targeted biopsies. Cancer. 2016 Mar 15;122(6):884-92. doi: 10.1002/cncr.29874. Epub 2016 Jan 7.

  PMID: 26749141 BACKGROUND

• Lamb BW, Tan WS, Rehman A, Nessa A, Cohen D, O'Neil J, Green JS, Hines JE. Is Prebiopsy MRI Good Enough to Avoid Prostate Biopsy? A Cohort Study Over a 1-Year Period. Clin Genitourin Cancer. 2015 Dec;13(6):512-7. doi: 10.1016/j.clgc.2015.06.007. Epub 2015 Jun 30.

  PMID: 26231912 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Multiparametric Magnetic Resonance Imaging; Urination

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Lars Lund, DMsc

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD-Student, MD

Model Details: Study subjects will be randomized in a 1:7 fashion between 1. Standard biopsies + biomarkers and 2. Biomarkers + mpMRI and Standard / mpMRI targeted biopsies.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: November 5, 2018
• Study Start: November 5, 2018
• Primary Completion: July 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

DK (1)