Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer.

Summary

The goal of this study type: observational study (prospective study) is to study prostate cancer occurrence and recurrence, to specifically identify and localize tumor foci at the molecular level at an early stage, to evaluate the prognosis of patients, and to accurately stage not only intermediate- and high-risk prostate cancer patients with a primary diagnosis, but also detect recurrent foci in patients with biochemical recurrence, to restage those who have developed metastases, to assess tumor load, and to ultimately assist in determining the personalized treatment plans. The main question it aims to answer is whether 68Ga-PSMA PET/CT (PET/MR) examination is beneficial for assessing the * Accurate staging of patients with intermediate- and high-risk prostate cancer at first diagnosis; * Detecting recurrent lesions in patients with recurrent tumors for re-staging; * Assessment of tumor load; * Assessment of patient prognosis. Participants will sign an informed consent form, undergo 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy, and have regular follow-up after obtaining pathological results of surgical resection or puncture biopsy, 6 weeks after surgery or biopsy, and then every 3 months; the follow-up will include: blood PSA, whole-body bone imaging, etc.

Timeline

Start

2022-04-28

Primary completion

2023-09-30

Completion

2027-03-31

Publications

• Results Pishgar F, Ebrahimi H, Saeedi Moghaddam S, Fitzmaurice C, Amini E. Global, Regional and National Burden of Prostate Cancer, 1990 to 2015: Results from the Global Burden of Disease Study 2015. J Urol. 2018 May;199(5):1224-1232. doi: 10.1016/j.juro.2017.10.044. Epub 2017 Nov 9.
• Results Schoder H, Larson SM. Positron emission tomography for prostate, bladder, and renal cancer. Semin Nucl Med. 2004 Oct;34(4):274-92. doi: 10.1053/j.semnuclmed.2004.06.004.
• Results Brawer MK, Ploch NR, Bigler SA. Prostate cancer tumor location as predicted by digital rectal examination transferred to ultrasound and ultrasound-guided prostate needle biopsy. J Cell Biochem Suppl. 1992;16H:74-7. doi: 10.1002/jcb.240501217.
• Results Jadvar H. Prostate cancer: PET with 18F-FDG, 18F- or 11C-acetate, and 18F- or 11C-choline. J Nucl Med. 2011 Jan;52(1):81-9. doi: 10.2967/jnumed.110.077941. Epub 2010 Dec 13.
• Results Choueiri TK, Dreicer R, Paciorek A, Carroll PR, Konety B. A model that predicts the probability of positive imaging in prostate cancer cases with biochemical failure after initial definitive local therapy. J Urol. 2008 Mar;179(3):906-10; discussion 910. doi: 10.1016/j.juro.2007.10.059. Epub 2008 Jan 22.
• Results Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6.
• Results Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available.
• Results Sivaraman A, Sanchez-Salas R. Re: can clinically significant prostate cancer be detected with multiparametric magnetic resonance imaging? A systematic review of the literature. Eur Urol. 2015 Oct;68(4):738. doi: 10.1016/j.eururo.2015.06.033. No abstract available.
• Results Grivas N, Lardas M, Espinos EL, Lam TB, Rouviere O, Mottet N, van den Bergh RCN; Members of the EAU-EANM-ESTRO-ESUR-ISUP-SIOG Prostate Cancer Guidelines Panel. Prostate Cancer Detection Percentages of Repeat Biopsy in Patients with Positive Multiparametric Magnetic Resonance Imaging (Prostate Imaging Reporting and Data System/Likert 3-5) and Negative Initial Biopsy. A Mini Systematic Review. Eur Urol. 2022 Nov;82(5):452-457. doi: 10.1016/j.eururo.2022.07.025. Epub 2022 Aug 18.
• Results Hovels AM, Heesakkers RA, Adang EM, Jager GJ, Strum S, Hoogeveen YL, Severens JL, Barentsz JO. The diagnostic accuracy of CT and MRI in the staging of pelvic lymph nodes in patients with prostate cancer: a meta-analysis. Clin Radiol. 2008 Apr;63(4):387-95. doi: 10.1016/j.crad.2007.05.022. Epub 2008 Feb 4.
• Results Gorin MA, Rowe SP, Denmeade SR. Clinical Applications of Molecular Imaging in the Management of Prostate Cancer. PET Clin. 2017 Apr;12(2):185-192. doi: 10.1016/j.cpet.2016.11.001. Epub 2017 Jan 16.
• Results Jani AB, Schreibmann E, Rossi PJ, Shelton J, Godette K, Nieh P, Master VA, Kucuk O, Goodman M, Halkar R, Cooper S, Chen Z, Schuster DM. Impact of 18F-Fluciclovine PET on Target Volume Definition for Postprostatectomy Salvage Radiotherapy: Initial Findings from a Randomized Trial. J Nucl Med. 2017 Mar;58(3):412-418. doi: 10.2967/jnumed.116.176057. Epub 2016 Sep 8.
• Results Park SY, Zacharias C, Harrison C, Fan RE, Kunder C, Hatami N, Giesel F, Ghanouni P, Daniel B, Loening AM, Sonn GA, Iagaru A. Gallium 68 PSMA-11 PET/MR Imaging in Patients with Intermediate- or High-Risk Prostate Cancer. Radiology. 2018 Aug;288(2):495-505. doi: 10.1148/radiol.2018172232. Epub 2018 May 22.
• Results Lutje S, Heskamp S, Cornelissen AS, Poeppel TD, van den Broek SA, Rosenbaum-Krumme S, Bockisch A, Gotthardt M, Rijpkema M, Boerman OC. PSMA Ligands for Radionuclide Imaging and Therapy of Prostate Cancer: Clinical Status. Theranostics. 2015 Oct 18;5(12):1388-401. doi: 10.7150/thno.13348. eCollection 2015.
• Results Demirkol MO, Acar O, Ucar B, Ramazanoglu SR, Saglican Y, Esen T. Prostate-specific membrane antigen-based imaging in prostate cancer: impact on clinical decision making process. Prostate. 2015 May;75(7):748-57. doi: 10.1002/pros.22956. Epub 2015 Jan 18.
• Results Liu T, Wu LY, Fulton MD, Johnson JM, Berkman CE. Prolonged androgen deprivation leads to downregulation of androgen receptor and prostate-specific membrane antigen in prostate cancer cells. Int J Oncol. 2012 Dec;41(6):2087-92. doi: 10.3892/ijo.2012.1649. Epub 2012 Oct 4.
• Results Eder M, Schafer M, Bauder-Wust U, Hull WE, Wangler C, Mier W, Haberkorn U, Eisenhut M. 68Ga-complex lipophilicity and the targeting property of a urea-based PSMA inhibitor for PET imaging. Bioconjug Chem. 2012 Apr 18;23(4):688-97. doi: 10.1021/bc200279b. Epub 2012 Mar 13.
• Results Weineisen M, Simecek J, Schottelius M, Schwaiger M, Wester HJ. Synthesis and preclinical evaluation of DOTAGA-conjugated PSMA ligands for functional imaging and endoradiotherapy of prostate cancer. EJNMMI Res. 2014 Dec;4(1):63. doi: 10.1186/s13550-014-0063-1. Epub 2014 Nov 25.
• Results Benesova M, Schafer M, Bauder-Wust U, Afshar-Oromieh A, Kratochwil C, Mier W, Haberkorn U, Kopka K, Eder M. Preclinical Evaluation of a Tailor-Made DOTA-Conjugated PSMA Inhibitor with Optimized Linker Moiety for Imaging and Endoradiotherapy of Prostate Cancer. J Nucl Med. 2015 Jun;56(6):914-20. doi: 10.2967/jnumed.114.147413. Epub 2015 Apr 16.
• Results Afshar-Oromieh A, Zechmann CM, Malcher A, Eder M, Eisenhut M, Linhart HG, Holland-Letz T, Hadaschik BA, Giesel FL, Debus J, Haberkorn U. Comparison of PET imaging with a (68)Ga-labelled PSMA ligand and (18)F-choline-based PET/CT for the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2014 Jan;41(1):11-20. doi: 10.1007/s00259-013-2525-5. Epub 2013 Sep 27.
• Results Afshar-Oromieh A, Hetzheim H, Kratochwil C, Benesova M, Eder M, Neels OC, Eisenhut M, Kubler W, Holland-Letz T, Giesel FL, Mier W, Kopka K, Haberkorn U. The Theranostic PSMA Ligand PSMA-617 in the Diagnosis of Prostate Cancer by PET/CT: Biodistribution in Humans, Radiation Dosimetry, and First Evaluation of Tumor Lesions. J Nucl Med. 2015 Nov;56(11):1697-705. doi: 10.2967/jnumed.115.161299. Epub 2015 Aug 20.

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