Multi-modality Imaging (PCa) Using Sodium MRI and PSMA PET in Men Pre-prostatectomy

Summary

The study is a non-randomized, prospective trial of men scheduled for radical prostatectomy for treatment of prostate cancer as standard of care and will undergo a series of pre-operative multi-modality imaging studies. Pre-operative imaging will be correlated with actual pathology results and statistical modeling performed to determine the most informative imaging biomarkers in predicting cancer location and aggressiveness (Gleason Score).

Timeline

Start

2021-02-04

Primary completion

2024-01-23

Completion

2025-09

Publications

• Background Chun FK, Karakiewicz PI, Briganti A, Walz J, Kattan MW, Huland H, Graefen M. A critical appraisal of logistic regression-based nomograms, artificial neural networks, classification and regression-tree models, look-up tables and risk-group stratification models for prostate cancer. BJU Int. 2007 Apr;99(4):794-800. doi: 10.1111/j.1464-410X.2006.06694.x.
• Background Makarov DV, Trock BJ, Humphreys EB, Mangold LA, Walsh PC, Epstein JI, Partin AW. Updated nomogram to predict pathologic stage of prostate cancer given prostate-specific antigen level, clinical stage, and biopsy Gleason score (Partin tables) based on cases from 2000 to 2005. Urology. 2007 Jun;69(6):1095-101. doi: 10.1016/j.urology.2007.03.042.
• Background Hricak H, Choyke PL, Eberhardt SC, Leibel SA, Scardino PT. Imaging prostate cancer: a multidisciplinary perspective. Radiology. 2007 Apr;243(1):28-53. doi: 10.1148/radiol.2431030580.
• Background Chan I, Wells W 3rd, Mulkern RV, Haker S, Zhang J, Zou KH, Maier SE, Tempany CM. Detection of prostate cancer by integration of line-scan diffusion, T2-mapping and T2-weighted magnetic resonance imaging; a multichannel statistical classifier. Med Phys. 2003 Sep;30(9):2390-8. doi: 10.1118/1.1593633.
• Background Barrett T, Turkbey B, Choyke PL. PI-RADS version 2: what you need to know. Clin Radiol. 2015 Nov;70(11):1165-76. doi: 10.1016/j.crad.2015.06.093. Epub 2015 Jul 29.
• Background Kwee SA, Thibault GP, Stack RS, Coel MN, Furusato B, Sesterhenn IA. Use of step-section histopathology to evaluate 18F-fluorocholine PET sextant localization of prostate cancer. Mol Imaging. 2008 Jan-Feb;7(1):12-20.
• Background Ward AD, Crukley C, McKenzie CA, Montreuil J, Gibson E, Romagnoli C, Gomez JA, Moussa M, Chin J, Bauman G, Fenster A. Prostate: registration of digital histopathologic images to in vivo MR images acquired by using endorectal receive coil. Radiology. 2012 Jun;263(3):856-64. doi: 10.1148/radiol.12102294. Epub 2012 Apr 2.
• Background Han W, Johnson C, Gaed M, Gomez JA, Moussa M, Chin JL, et al. Automatic cancer detection and localization on prostatectomy histopathology images. In: Tomaszewski JE, Gurcan MN, editors. Medical Imaging 2018: Digital Pathology. Proceedings of SPIE. 10581. Bellingham: Spie-Int Soc Optical Engineering; 2018
• Background Alfano R, Soetemans D, Bauman GS, Gibson E, Gaed M, Moussa M, et al. Development of a Computer Aided Diagnosis Model for Prostate Cancer Classification on Multi-Parametric MRI. In: Petrick N, Mori K, editors. Medical Imaging 2018: Computer-Aided Diagnosis. Proceedings of SPIE. 10575. Bellingham: Spie-Int Soc Optical Engineering; 2018.
• Background Evans JD, Jethwa KR, Ost P, Williams S, Kwon ED, Lowe VJ, Davis BJ. Prostate cancer-specific PET radiotracers: A review on the clinical utility in recurrent disease. Pract Radiat Oncol. 2018 Jan-Feb;8(1):28-39. doi: 10.1016/j.prro.2017.07.011. Epub 2017 Jul 20.
• Background Broeke NC, Peterson J, Lee J, Martin PR, Farag A, Gomez JA, Moussa M, Gaed M, Chin J, Pautler SE, Ward A, Bauman G, Bartha R, Scholl TJ. Characterization of clinical human prostate cancer lesions using 3.0-T sodium MRI registered to Gleason-graded whole-mount histopathology. J Magn Reson Imaging. 2019 May;49(5):1409-1419. doi: 10.1002/jmri.26336. Epub 2018 Nov 14.
• Background Bauman G, Martin P, Thiessen JD, Taylor R, Moussa M, Gaed M, Rachinsky I, Kassam Z, Chin J, Pautler S, Lee TY, Valliant JF, Ward A. [18F]-DCFPyL Positron Emission Tomography/Magnetic Resonance Imaging for Localization of Dominant Intraprostatic Foci: First Experience. Eur Urol Focus. 2018 Sep;4(5):702-706. doi: 10.1016/j.euf.2016.10.002. Epub 2016 Oct 26.
• Background Uprimny C, Kroiss AS, Decristoforo C, Fritz J, von Guggenberg E, Kendler D, Scarpa L, di Santo G, Roig LG, Maffey-Steffan J, Horninger W, Virgolini IJ. 68Ga-PSMA-11 PET/CT in primary staging of prostate cancer: PSA and Gleason score predict the intensity of tracer accumulation in the primary tumour. Eur J Nucl Med Mol Imaging. 2017 Jun;44(6):941-949. doi: 10.1007/s00259-017-3631-6. Epub 2017 Jan 31.
• Background Barrett T, Riemer F, McLean MA, Kaggie J, Robb F, Tropp JS, Warren A, Bratt O, Shah N, Gnanapragasam VJ, Gilbert FJ, Graves MJ, Gallagher FA. Quantification of Total and Intracellular Sodium Concentration in Primary Prostate Cancer and Adjacent Normal Prostate Tissue With Magnetic Resonance Imaging. Invest Radiol. 2018 Aug;53(8):450-456. doi: 10.1097/RLI.0000000000000470.
• Background Kozlowski P, Chang SD, Meng R, Madler B, Bell R, Jones EC, Goldenberg SL. Combined prostate diffusion tensor imaging and dynamic contrast enhanced MRI at 3T--quantitative correlation with biopsy. Magn Reson Imaging. 2010 Jun;28(5):621-8. doi: 10.1016/j.mri.2010.03.011. Epub 2010 Apr 13.
• Background Ghai S, Haider MA. Multiparametric-MRI in diagnosis of prostate cancer. Indian J Urol. 2015 Jul-Sep;31(3):194-201. doi: 10.4103/0970-1591.159606.
• Background Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.
• Background Moore CM, Giganti F, Albertsen P, Allen C, Bangma C, Briganti A, Carroll P, Haider M, Kasivisvanathan V, Kirkham A, Klotz L, Ouzzane A, Padhani AR, Panebianco V, Pinto P, Puech P, Rannikko A, Renard-Penna R, Touijer K, Turkbey B, van Poppel H, Valdagni R, Walz J, Schoots I. Reporting Magnetic Resonance Imaging in Men on Active Surveillance for Prostate Cancer: The PRECISE Recommendations-A Report of a European School of Oncology Task Force. Eur Urol. 2017 Apr;71(4):648-655. doi: 10.1016/j.eururo.2016.06.011. Epub 2016 Jun 24.
• Background Ehdaie B, Assel M, Benfante N, Malhotra D, Vickers A. A Systematic Approach to Discussing Active Surveillance with Patients with Low-risk Prostate Cancer. Eur Urol. 2017 Jun;71(6):866-871. doi: 10.1016/j.eururo.2016.12.026. Epub 2017 Jan 24.
• Background Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.
• Background Klotz L. Active surveillance: the Canadian experience. Curr Opin Urol. 2012 May;22(3):222-30. doi: 10.1097/MOU.0b013e328352598c.
• Background Wibmer AG, Burger IA, Sala E, Hricak H, Weber WA, Vargas HA. Molecular Imaging of Prostate Cancer. Radiographics. 2016 Jan-Feb;36(1):142-59. doi: 10.1148/rg.2016150059. Epub 2015 Nov 20.
• Background Sanyal C, Aprikian AG, Cury FL, Chevalier S, Dragomir A. Management of localized and advanced prostate cancer in Canada: A lifetime cost and quality-adjusted life-year analysis. Cancer. 2016 Apr 1;122(7):1085-96. doi: 10.1002/cncr.29892. Epub 2016 Feb 1.
• Background Hoeks CM, Barentsz JO, Hambrock T, Yakar D, Somford DM, Heijmink SW, Scheenen TW, Vos PC, Huisman H, van Oort IM, Witjes JA, Heerschap A, Futterer JJ. Prostate cancer: multiparametric MR imaging for detection, localization, and staging. Radiology. 2011 Oct;261(1):46-66. doi: 10.1148/radiol.11091822.
• Background Udovicich C, Perera M, Hofman MS, Siva S, Del Rio A, Murphy DG, Lawrentschuk N. 68Ga-prostate-specific membrane antigen-positron emission tomography/computed tomography in advanced prostate cancer: Current state and future trends. Prostate Int. 2017 Dec;5(4):125-129. doi: 10.1016/j.prnil.2017.02.003. Epub 2017 Feb 24.
• Background Ward A, Crukley C, McKenzie C, Montreuil J, Gibson E, Gomez JA, et al. Registration of in vivo prostate magnetic resonance images to digital histopathology images. MICCAI'10 Proceedings of the 2010 international conference on Prostate cancer imaging: computer-aided diagnosis, prognosis, and intervention; Bejing, China. Berlin: Springer-Verlag; 2010
• Background Hambrock T, Somford DM, Huisman HJ, van Oort IM, Witjes JA, Hulsbergen-van de Kaa CA, Scheenen T, Barentsz JO. Relationship between apparent diffusion coefficients at 3.0-T MR imaging and Gleason grade in peripheral zone prostate cancer. Radiology. 2011 May;259(2):453-61. doi: 10.1148/radiol.11091409.
• Background Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998 Jul 30;17(14):1623-34. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-s.

Drugs

Indications