Prostate Cancer Clinical Trial
— CADMUSOfficial title:
Multi-parametric Ultrasound Targeted Biopsies Compared to Multi-parametric MRI Targeted Biopsies in the Diagnosis of Clinically Significant Prostate Cancer
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?
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London Hospitals | London, | England |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
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
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 |
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