Cancer Diagnosis by Multiparametric UltraSound of the Prostate

NCT02712684 | Unknown DMC

• 1 other identifier: 15/0473
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar detection of clinically significant prostate cancer?

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the overall agreement in identifying lesions to biopsy between mp-USS and mp-MRI in men who require a prostate biopsy. Then compare agreement in proportion of men diagnosed with clinically significant prostate cancer on biopsy.

  Clinically significant for the purpose will be defined by UCL/Ahmed definition 1:Gleason ≥4+3 and/or maximum cancer core length of ≥ 6mm

  at time of surgery

Secondary Outcomes (6)

• To compare the overall agreement in proportion of men diagnosed with other thresholds of clinically significant prostate cancer on biopsy

  at time of surgery

• To determine the detection of clinically significant cancer (using all of the pre-specified definitions based on histology) by using the combination of these two imaging techniques versus either modality alone

  at time of surgery

• To determine whether the order in which the targeted biopsies are carried out, either to the same target (present on both scans) or different targets impacts on detection of clinically significant cancer

  at time of surgery

• To compare, in those men who go on to radical prostatectomy, the mp-MRI, mp-USS and histology from targeted biopsy with the whole mount specimen obtained at surgery.

  at time of surgery

• To create an inception cohort of men, consented for long-term follow-up and linkage, providing the potential for further translational and clinical studies

  at time of surgery

Interventions

multiparametric MRI. Multi-parametric ultrasound PROCEDURE

The investigators aim to test the hypothesis that multiparametric ultrasound is able to detect clinically significant prostate cancer with an accuracy that is similar to multiparametric MRI. Multi-parametric ultrasound uses different types of ultrasound images to visualise different aspects of the tissue. In other words, the standard grey-scale images shows the gross anatomy, Power Doppler and Contrast enhanced Ultrasound image blood supply (cancers have more blood supply), and Real-Time Elastography images the density of tissue (cancers are more dense).

Eligibility Criteria

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

Study Population

Men at or referred to the participating centres who may require a prostate biopsy. Referrals will be screened and potential participants contacted by telephone, post or email. These men will be given the patient information sheet at least 24 hours before their clinic visit, allowing adequate time to consider their desire for involvement

You may qualify if:

• A potential need for prostate biopsy indicated by raised PSA or other clinical parameter, the final decision over which will be taken after imaging.
• PSA \</=20ng/ml measured within 6 months of screening visit
• An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
• Estimated life expectancy of 5 years or more
• Signed informed consent

You may not qualify if:

• Any contraindication to the ultrasound contrast agent including right to left shunt, pulmonary hypertension, uncontrolled hypertension and adult respiratory distress syndrome. Also patients with a recent acute coronary syndrome or unstable ischaemic heart disease.
• Any form of hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit
• Irreversible coagulopathy predisposing to bleeding
• Inability to undergo transrectal ultrasonography
• Prostate volume, measured at the time of mp-USS if previously unknown, of \>60cc.
• Previous radiation therapy to the prostate
• Previous HIFU, cryosurgery, thermal therapy, irreversible electroporation, photodynamic, photothermal therapy, microwave or injectable toxin therapy to the prostate.
• Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality within 6 months of screening visit
• Nodal or metastatic prostate cancer on any form of imaging at any time-point
• Not fit for general anaesthetic
• Any other condition the investigator considers would make the patient unsuitable

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals

London, England, WIT 3AA, United Kingdom

RECRUITING

Related Publications (7)

• Velonas VM, Woo HH, dos Remedios CG, Assinder SJ. Current status of biomarkers for prostate cancer. Int J Mol Sci. 2013 May 24;14(6):11034-60. doi: 10.3390/ijms140611034.

  PMID: 23708103 RESULT

• Kirkham AP, Haslam P, Keanie JY, McCafferty I, Padhani AR, Punwani S, Richenberg J, Rottenberg G, Sohaib A, Thompson P, Turnbull LW, Kurban L, Sahdev A, Clements R, Carey BM, Allen C. Prostate MRI: who, when, and how? Report from a UK consensus meeting. Clin Radiol. 2013 Oct;68(10):1016-23. doi: 10.1016/j.crad.2013.03.030. Epub 2013 Jul 1.

  PMID: 23827086 RESULT

• Welch HG, Albertsen PC. Prostate cancer diagnosis and treatment after the introduction of prostate-specific antigen screening: 1986-2005. J Natl Cancer Inst. 2009 Oct 7;101(19):1325-9. doi: 10.1093/jnci/djp278. Epub 2009 Aug 31.

  PMID: 19720969 RESULT

• Wilt TJ, Ahmed HU. Prostate cancer screening and the management of clinically localized disease. BMJ. 2013 Jan 29;346:f325. doi: 10.1136/bmj.f325. No abstract available.

  PMID: 23360718 RESULT

• Wei JT. Limitations of a contemporary prostate biopsy: the blind march forward. Urol Oncol. 2010 Sep-Oct;28(5):546-9. doi: 10.1016/j.urolonc.2009.12.022.

  PMID: 20816614 RESULT

• Thompson IM, Ankerst DP, Tangen CM. Prostate-specific antigen, risk factors, and prostate cancer: confounders nestled in an enigma. J Natl Cancer Inst. 2010 Sep 8;102(17):1299-301. doi: 10.1093/jnci/djq313. Epub 2010 Aug 19. No abstract available.

  PMID: 20724727 RESULT

• Grey ADR, Scott R, Shah B, Acher P, Liyanage S, Pavlou M, Omar R, Chinegwundoh F, Patki P, Shah TT, Hamid S, Ghei M, Gilbert K, Campbell D, Brew-Graves C, Arumainayagam N, Chapman A, McLeavy L, Karatziou A, Alsaadi Z, Collins T, Freeman A, Eldred-Evans D, Bertoncelli-Tanaka M, Tam H, Ramachandran N, Madaan S, Winkler M, Arya M, Emberton M, Ahmed HU. Multiparametric ultrasound versus multiparametric MRI to diagnose prostate cancer (CADMUS): a prospective, multicentre, paired-cohort, confirmatory study. Lancet Oncol. 2022 Mar;23(3):428-438. doi: 10.1016/S1470-2045(22)00016-X.

  PMID: 35240084 DERIVED

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

Central Study Contacts

Bina Shah

CONTACT

+44 (0)20 7679 9280; SITU.CADMUS@ucl.ac.uk

Study Design

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

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: March 18, 2016
• Study Start: July 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)