A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol
Magdalena Szewczyk-Bieda, Cheng Wei, Katherine Coll, Stephen Gandy, Peter Donnan, Senthil Kumar Arcot Ragupathy, Paras Singh, Jennifer Wilson, Ghulam Nabi, Magdalena Szewczyk-Bieda, Cheng Wei, Katherine Coll, Stephen Gandy, Peter Donnan, Senthil Kumar Arcot Ragupathy, Paras Singh, Jennifer Wilson, Ghulam Nabi
Abstract
Background: There is growing evidence suggesting that multiparametric magnetic resonance imaging (mpMRI) is a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.
Methods and materials: This is a prospective multicentre study of pre-biopsy mpMRI diagnostic test accuracy with subgroup randomisation at a 1:1 ratio with respect to transrectal ultrasound (TRUS) and MRI/US fusion-guided biopsy or TRUS-only biopsy. It is designed as a single-gate study with a single set of inclusion criteria. The total duration of the recruitment phase was 48 months; however, this has now been extended to 66 months. A sample size of 600 participants is required.
Discussion: The primary objective is to determine whether mpMRI can improve PCa detection and characterisation. The key secondary objective is to determine whether MRI/US fusion-guided biopsy can reduce the number of false-negative biopsies. Ethical approval was obtained from the East of Scotland Research Ethics Committee 1 (14/ES/1070) on 20 November 2014. The results of this study will be used for publication and presentation in national and international journals and at scientific conferences.
Trial registration: ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016.
Keywords: Multiparametric magnetic resonance imaging; Prostate biopsy; Prostate cancer.
Conflict of interest statement
The MULTIPROS study and all authors declare no competing interest.
Figures
References
- Taira AV, Merrick GS, Galbreath RW, et al. Performance of transperineal template-guided mapping biopsy in detecting prostate cancer in the initial and repeat biopsy setting. Prostate Cancer Prostatic Dis. 2010;13:71. doi: 10.1038/pcan.2009.42.
- Welch HG, Fisher ES, Gottlieb DJ, et al. Detection of prostate cancer via biopsy in the Medicare–SEER population during the PSA era. JNCI. 2007;99:1395. doi: 10.1093/jnci/djm119.
- Rosario DJ, Lane JA, Metcalfe C, et al. Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. BMJ. 2012;344:d7894. doi: 10.1136/bmj.d7894.
- Schröder FH, Hugosson J, Roobol MJ, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009;360:1320. doi: 10.1056/NEJMoa0810084.
- Tamada T, Sone T, Jo Y, et al. Prostate cancer: relationships between postbiopsy hemorrhage and tumor detectability at MR diagnosis. Radiology. 2008;248:531. doi: 10.1148/radiol.2482070157.
- Qayyum A, Coakley FV, Lu Y, et al. Organ-confined prostate cancer: effect of prior transrectal biopsy on endorectal MRI and MR spectroscopic imaging. Am J Roentgenol. 2004;183:1079. doi: 10.2214/ajr.183.4.1831079.
- Kirkham APS, Haslam P, Keanie JY, et al. Prostate MRI: who, when, and how? Report from a UK consensus meeting. Clin Radiol. 2013;68:1016. doi: 10.1016/j.crad.2013.03.030.
- Rais-Bahrami S, Siddiqui MM, Turkbey B, et al. Utility of multiparametric magnetic resonance imaging suspicion levels for detecting prostate cancer. J Urol. 2013;190:1721. doi: 10.1016/j.juro.2013.05.052.
- Sheikh N, Wei C, Szewczyk-Bieda M, et al. Combined T2 and diffusion-weighted MR imaging with template prostate biopsies in men suspected with prostate cancer but negative transrectal ultrasound-guided biopsies. World J Urol. 2017;35:213. doi: 10.1007/s00345-016-1855-x.
- Wei C, Jin B, Szewczyk-Bieda M, et al. Quantitative parameters in dynamic contrast-enhanced magnetic resonance imaging for the detection and characterization of prostate cancer. Oncotarget. 2018;9:15997.
- Shah V, Pohida T, Turkbey B, et al. A method for correlating in vivo prostate magnetic resonance imaging and histopathology using individualized magnetic resonance-based molds. Rev Sci Instrum. 2009;80:104301. doi: 10.1063/1.3242697.
Source: PubMed