Cancer Diagnosis by Multiparametric UltraSound of the Prostate

Prostate Cancer Clinical Trial

— CADMUS  

Official title:

Multi-parametric Ultrasound Targeted Biopsies Compared to Multi-parametric MRI Targeted Biopsies in the Diagnosis of Clinically Significant Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02712684
• Other study ID #: 15/0473
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2016
• Last updated: August 8, 2016
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: University College, London
• Contact: Bina Shah
• Phone: +44 (0)20 7679 9280
• Email: SITU.CADMUS[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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?

Description:

Men who require prostate biopsy will be approached and consented to enter this study. Participants will all undergo pre-biopsy mp-MRI and mp-USS of the prostate. Only men with positive scans will undergo prostate biopsy. The order in which lesions discovered on mp-MRI or on mp-USS are sampled will be randomised. All biopsies will be taken via the transperineal route in a single procedure. Comparison will be drawn between biopsy results of lesions detected by mp-USS with those lesions detected by mp-MRI. Consideration will be given as to whether a lesion detected by one imaging modality is the same abnormality as one detected by the other imaging modality, in the same patient. Analysis will be carried out at both the level of the lesion and the whole prostate. Men without suspicious lesions on either imaging modality will not proceed to biopsy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. A potential need for prostate biopsy indicated by raised PSA or other clinical parameter, the final decision over which will be taken after imaging.

2. PSA </=20ng/ml measured within 6 months of screening visit

3. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process

4. Estimated life expectancy of 5 years or more

5. Signed informed consent

Exclusion Criteria:

1. 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.

2. Any form of hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit

3. Irreversible coagulopathy predisposing to bleeding

4. Inability to undergo transrectal ultrasonography

5. Prostate volume, measured at the time of mp-USS if previously unknown, of >60cc.

6. Previous radiation therapy to the prostate

7. Previous HIFU, cryosurgery, thermal therapy, irreversible electroporation, photodynamic, photothermal therapy, microwave or injectable toxin therapy to the prostate.

8. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality within 6 months of screening visit

9. Nodal or metastatic prostate cancer on any form of imaging at any time-point

10. Not fit for general anaesthetic

11. Any other condition the investigator considers would make the patient unsuitable

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• multiparametric MRI. Multi-parametric ultrasound
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).

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals	London,	England

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. C — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To compare the overall agreement in proportion of men diagnosed with other thresholds of clinically significant prostate cancer on biopsy	Thresholds for clinical significance namely UCL/Ahmed definition 2 (a) Gleason = 3+4 and/or Maximum cancer core length = 4mm, (b) Gleason = 3+4 and or MCCL = 6mm (c) Any length of Gleason = 3+4 (d) Any length of Gleason =4+3	at time of surgery	No
Secondary	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	No
Secondary	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	clinically significant cancer (using all of the pre-specified definitions based on histology)	at time of surgery	No
Secondary	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	No
Secondary	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	No
Secondary	To determine rates of adverse events, resource utilization and impact of each test on health-related quality-of-life (using EQ-5D-5L questionnaire) which would allow modelling of overall cost-effectiveness of one strategy compared to the other.		at time of surgery	No