Clinical trial · Observational
Cancer Diagnosis by Multiparametric UltraSound of the Prostate
Multi-parametric Ultrasound Targeted Biopsies Compared to Multi-parametric MRI Targeted Biopsies in the Diagnosis of Clinically Significant Prostate Cancer
NCT02712684CI-TRIAL-00023405CADMUSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multiparametric MRI. Multi-parametric ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- at time of surgery
- description
- Clinically significant for the purpose will be defined by UCL/Ahmed definition 1:Gleason ≥4+3 and/or maximum cancer core length of ≥ 6mm
Secondary outcomes (6)
- measure
- To compare the overall agreement in proportion of men diagnosed with other thresholds of clinically significant prostate cancer on biopsy
- timeFrame
- at time of surgery
- description
- 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
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTVelonas 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
- RESULTKirkham 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
- RESULTWelch 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
- RESULTWilt 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
- RESULTWei 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
- RESULTThompson 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
- DERIVEDGrey 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.