Multiparametric Ultrasound Imaging in Prostate Cancer

NCT03101176 | Unknown

• 1 other identifier: NL58710.018.07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The current limitations in prostate cancer diagnostics, due to lack of accuracy of the available techniques, lead to over- and undertreatment for a significant fraction of patients with prostate cancer. Multiparametric ultrasound (mpUS), a new imaging modality combining different ultrasound parameters, heralds the potential for an accurate imaging-based diagnostic approach accessible to the community at large but formal validation of mpUS against final pathology results are still lacking. Objective: To validate mpUS as imaging modality for detection and localization of prostate cancer by direct correlation with histopathology of radical prostatectomy specimens

Conditions

Prostate Cancer; Prostatic Neoplasms

Keywords

multiparametric ultrasound; prostate cancer; contrast ultrasound; CEUS; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Validation of mpUS

  Predictive accuracy in terms of sensitivity and specificity of mpUS imaging in the detection and localization of prostate cancer by qualitatively and semi-quantitatively correlation of mpUS imaging to corresponding radical prostatectomy histopathology

  5 years

Secondary Outcomes (2)

• Differences in mpUS parameters between benign and malignant (low-grade and high-grade) prostate tissue

  5 years

• mpUS and mpMRI comparison

  5 years

Study Arms (1)

Experimental: Single Arm

EXPERIMENTAL

All consenting patients will undergo mpUS imaging prior to surgery with the ultrasound contrast agent Sonovue for the CEUS specific mode.

Drug: SonoVue

Interventions

SonoVue DRUG

The ultrasound contrast agent used for the CEUS specific ultrasound mode

Also known as: sulphur hexafluoride

Experimental: Single Arm

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years
• biopsy proven prostate carcinoma
• planned treatment by (robot laparoscopic) radical prostatectomy
• signed informed consent

You may not qualify if:

• Chemotherapy, radiotherapy or focal therapy of the prostate for prostate cancer
• Hormonal therapy for prostate cancer within last six months
• History of any clinically evidence of cardiac right-to-left shunts
• Receives treatment that includes dobutamine
• Severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
• Is incapable of understanding the language in which the information for the patient is given

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Amsterdam UMC, location VUmc: collaborator

Study Sites (1)

AMC University Hospital

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Related Publications (9)

• Bjurlin MA, Carter HB, Schellhammer P, Cookson MS, Gomella LG, Troyer D, Wheeler TM, Schlossberg S, Penson DF, Taneja SS. Optimization of initial prostate biopsy in clinical practice: sampling, labeling and specimen processing. J Urol. 2013 Jun;189(6):2039-46. doi: 10.1016/j.juro.2013.02.072. Epub 2013 Feb 26.

  PMID: 23485507 BACKGROUND

• Ukimura O, Coleman JA, de la Taille A, Emberton M, Epstein JI, Freedland SJ, Giannarini G, Kibel AS, Montironi R, Ploussard G, Roobol MJ, Scattoni V, Jones JS. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol. 2013 Feb;63(2):214-30. doi: 10.1016/j.eururo.2012.09.033. Epub 2012 Sep 25.

  PMID: 23021971 BACKGROUND

• Borghesi M, Ahmed H, Nam R, Schaeffer E, Schiavina R, Taneja S, Weidner W, Loeb S. Complications After Systematic, Random, and Image-guided Prostate Biopsy. Eur Urol. 2017 Mar;71(3):353-365. doi: 10.1016/j.eururo.2016.08.004. Epub 2016 Aug 17.

  PMID: 27543165 BACKGROUND

• Schoots IG, Roobol MJ, Nieboer D, Bangma CH, Steyerberg EW, Hunink MG. Magnetic resonance imaging-targeted biopsy may enhance the diagnostic accuracy of significant prostate cancer detection compared to standard transrectal ultrasound-guided biopsy: a systematic review and meta-analysis. Eur Urol. 2015 Sep;68(3):438-50. doi: 10.1016/j.eururo.2014.11.037. Epub 2014 Dec 3.

  PMID: 25480312 BACKGROUND

• Muller BG, Shih JH, Sankineni S, Marko J, Rais-Bahrami S, George AK, de la Rosette JJ, Merino MJ, Wood BJ, Pinto P, Choyke PL, Turkbey B. Prostate Cancer: Interobserver Agreement and Accuracy with the Revised Prostate Imaging Reporting and Data System at Multiparametric MR Imaging. Radiology. 2015 Dec;277(3):741-50. doi: 10.1148/radiol.2015142818. Epub 2015 Jun 18.

  PMID: 26098458 BACKGROUND

• Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.

  PMID: 27618134 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

• Grey A, Ahmed HU. Multiparametric ultrasound in the diagnosis of prostate cancer. Curr Opin Urol. 2016 Jan;26(1):114-9. doi: 10.1097/MOU.0000000000000245.

  PMID: 26555694 BACKGROUND

• Postema A, Mischi M, de la Rosette J, Wijkstra H. Multiparametric ultrasound in the detection of prostate cancer: a systematic review. World J Urol. 2015 Nov;33(11):1651-9. doi: 10.1007/s00345-015-1523-6. Epub 2015 Mar 12.

  PMID: 25761736 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

contrast agent BR1; Sulfur Hexafluoride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds

Study Officials

• H. Wijkstra, Prof dr ir

  AMC University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

H. Wijkstra, Prof dr ir

CONTACT

+31 20 5666379; h.wijkstra@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Ir. Hessel Wijkstra

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 5, 2017
• Study Start: September 7, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)