Subscribe to RSS
DOI: 10.1055/a-1984-8167
DGN-Handlungsempfehlung (S1-Leitlinie) – PSMA-Liganden-PET/CT in der Diagnostik des Prostatakarzinoms – Stand: 01/2022 – AWMF-Registernummer: 031-055
Procedure Guideline for Prostate Cancer Imaging with PSMA-ligand PET/CT
Abstract
PSMA-PET/CT for imaging prostate cancer (PC) has spread worldwide since its clinical introduction in 2011. The majority of experiences have been collected for PSMA-PET-imaging of recurrent PC. Data for primary staging of high-risk PC are highly promising. Meanwhile, a plethora of PSMA-ligands are available for clinical use (e. g. 68Ga-PSMA-11, 68Ga-PSMA-I&T, 68Ga-PSMA-617, 18F-DCFBC, 18F-DCFPyL, 18F-PSMA-1007, 18F-rhPSMA-7 and 18F-JK-PSMA-7). However, an official approval is available only for 68Ga-PSMA-11 (approved by the US FDA in 2020) and 18F-DCFPyL (approved by the US FDA in 2021).
Recommendations for acquisition times vary from 1–2 h p. i. It has been shown that for the majority of tumour lesions, the contrast in PSMA-PET/CT increases with time. Therefore, additional late imaging can help to clarify unclear findings. PSMA-PET/CT should be performed prior to commencing an androgen deprivation therapy (ADT) since (long term) ADT reduces the visibility of PC lesions. Following injection of PSMA-ligands, hydration and forced diuresis are recommended for PSMA-ligands with primarily excretion via the kidneys in order to increase the visibility of tumour lesions adjacent to the urinary bladder.
PSMA-ligands are physiologically taken up in multiple normal organs. For some 18F-labelled PSMA-ligands, presence of unspecific focal bone uptake has been reported. When using these tracers, focal bone uptake without CT-correlate should be interpreted with great caution. Besides prostate cancer, practically all solid tumors express PSMA in their neovasculature thereby taking up PSMA-ligands, although usually at a lower extent compared to PC. Also multiple benign lesions and inflammatory processes (e. g. lymph nodes) take up PSMA-ligands, also usually at lower extent compared to PC.
Key words
PSMA - PET/CT - prostate cancer - guideline - positron emission tomography - prostate specific membrane antigen* Beide Autoren haben gleichwertig zum Manuskript dieser Leitlinie beigetragen.
Publication History
Received: 16 November 2022
Accepted: 21 November 2022
Article published online:
06 February 2023
© 2023. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
Literatur
- 1 Current Procedural Terminology – Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging. https://bioportal.bioontology.org/ontologies/CPT
- 2 https://www.bundesaerztekammer.de/fileadmin/user_upload/downloads/LeitCT2007Korr-1.pdf
- 3 https://www.leitlinienprogramm-onkologie.de/leitlinien/prostatakarzinom/
- 4 Afshar-Oromieh A, Avtzi E, Giesel FL. et al. The diagnostic value of PET/CT imaging with the (68)Ga-labelled PSMA ligand HBED-CC in the diagnosis of recurrent prostate cancer. European journal of nuclear medicine and molecular imaging 2015; 42: 197-209 DOI: 10.1007/s00259-014-2949-6.
- 5 Eiber M, Maurer T, Souvatzoglou M. et al. Evaluation of Hybrid (6)(8)Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2015; 56: 668-674 DOI: 10.2967/jnumed.115.154153.
- 6 Afshar-Oromieh A, Holland-Letz T, Giesel FL. et al. Diagnostic performance of (68)Ga-PSMA-11 (HBED-CC) PET/CT in patients with recurrent prostate cancer: evaluation in 1007 patients. European journal of nuclear medicine and molecular imaging 2017; 44: 1258-1268 DOI: 10.1007/s00259-017-3711-7.
- 7 Berliner C, Tienken M, Frenzel T. et al. Detection rate of PET/CT in patients with biochemical relapse of prostate cancer using [(68)Ga]PSMA I&T and comparison with published data of [(68)Ga]PSMA HBED-CC. European journal of nuclear medicine and molecular imaging 2017; 44: 670-677 DOI: 10.1007/s00259-016-3572-5.
- 8 Afshar-Oromieh A, da Cunha ML, Wagner J. et al. Performance of [(68)Ga]Ga-PSMA-11 PET/CT in patients with recurrent prostate cancer after prostatectomy-a multi-centre evaluation of 2533 patients. European journal of nuclear medicine and molecular imaging 2021; DOI: 10.1007/s00259-021-05189-3.
- 9 Fendler WP, Calais J, Eiber M. et al. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA oncology 2019; DOI: 10.1001/jamaoncol.2019.0096.
- 10 McCarthy M, Langton T, Kumar D. et al. Comparison of PSMA-HBED and PSMA-I&T as diagnostic agents in prostate carcinoma. European journal of nuclear medicine and molecular imaging 2017; 44: 1455-1462 DOI: 10.1007/s00259-017-3699-z.
- 11 Perera M, Papa N, Roberts M. et al. Gallium-68 Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer-Updated Diagnostic Utility, Sensitivity, Specificity, and Distribution of Prostate-specific Membrane Antigen-avid Lesions: A Systematic Review and Meta-analysis. European urology 2020; 77: 403-417 DOI: 10.1016/j.eururo.2019.01.049.
- 12 Hofman MS, Lawrentschuk N, Francis RJ. et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet 2020; 395: 1208-1216 DOI: 10.1016/S0140-6736(20)30314-7.
- 13 Maurer T, Gschwend JE, Rauscher I. et al. Diagnostic Efficacy of (68)Gallium-PSMA Positron Emission Tomography Compared to Conventional Imaging for Lymph Node Staging of 130 Consecutive Patients with Intermediate to High Risk Prostate Cancer. The Journal of urology 2016; 195: 1436-1443 DOI: 10.1016/j.juro.2015.12.025.
- 14 Herlemann A, Wenter V, Kretschmer A. et al. (68)Ga-PSMA Positron Emission Tomography/Computed Tomography Provides Accurate Staging of Lymph Node Regions Prior to Lymph Node Dissection in Patients with Prostate Cancer. European urology 2016; 70: 553-557 DOI: 10.1016/j.eururo.2015.12.051.
- 15 Hijazi S, Meller B, Leitsmann C. et al. Pelvic lymph node dissection for nodal oligometastatic prostate cancer detected by 68Ga-PSMA-positron emission tomography/computerized tomography. The Prostate 2015; 75: 1934-1940 DOI: 10.1002/pros.23091.
- 16 Pyka T, Okamoto S, Dahlbender M. et al. Comparison of bone scintigraphy and (68)Ga-PSMA PET for skeletal staging in prostate cancer. European journal of nuclear medicine and molecular imaging 2016; 43: 2114-2121 DOI: 10.1007/s00259-016-3435-0.
- 17 Roach PJ, Francis R, Emmett L. et al. The Impact of (68)Ga-PSMA PET/CT on Management Intent in Prostate Cancer: Results of an Australian Prospective Multicenter Study. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2018; 59: 82-88 DOI: 10.2967/jnumed.117.197160.
- 18 Ferdinandus J, Eppard E, Gaertner FC. et al. Predictors of Response to Radioligand Therapy of Metastatic Castrate-Resistant Prostate Cancer with 177Lu-PSMA-617. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2017; 58: 312-319 DOI: 10.2967/jnumed.116.178228.
- 19 Eiber M, Weirich G, Holzapfel K. et al. Simultaneous (68)Ga-PSMA HBED-CC PET/MRI Improves the Localization of Primary Prostate Cancer. European urology 2016; 70: 829-836 DOI: 10.1016/j.eururo.2015.12.053.
- 20 Simopoulos DN, Natarajan S, Jones TA. et al. Targeted Prostate Biopsy Using (68)Gallium PSMA-PET/CT for Image Guidance. Urology case reports 2017; 14: 11-14 DOI: 10.1016/j.eucr.2017.05.006.
- 21 Fendler WP, Schmidt DF, Wenter V. et al. 68Ga-PSMA PET/CT Detects the Location and Extent of Primary Prostate Cancer. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2016; 57: 1720-1725 DOI: 10.2967/jnumed.116.172627.
- 22 Scher HI, Morris MJ, Stadler WM. et al. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. Journal of clinical oncology: official journal of the American Society of Clinical Oncology 2016; 34: 1402-1418 DOI: 10.1200/JCO.2015.64.2702.
- 23 https://www.clinicaltrials.gov/
- 24 Eder M, Schafer M, Bauder-Wust U. et al. 68Ga-complex lipophilicity and the targeting property of a urea-based PSMA inhibitor for PET imaging. Bioconjugate chemistry 2012; 23: 688-697 DOI: 10.1021/bc200279b.
- 25 Weineisen M, Schottelius M, Simecek J. et al. 68Ga- and 177Lu-Labeled PSMA I&T: Optimization of a PSMA-Targeted Theranostic Concept and First Proof-of-Concept Human Studies. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2015; 56: 1169-1176 DOI: 10.2967/jnumed.115.158550.
- 26 Benesova M, Schafer M, Bauder-Wust U. et al. Preclinical Evaluation of a Tailor-Made DOTA-Conjugated PSMA Inhibitor with Optimized Linker Moiety for Imaging and Endoradiotherapy of Prostate Cancer. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2015; 56: 914-920 DOI: 10.2967/jnumed.114.147413.
- 27 Mease RC, Dusich CL, Foss CA. et al. N-[N-[(S)-1,3-Dicarboxypropyl]carbamoyl]-4-[18F]fluorobenzyl-L-cysteine, [18F]DCFBC: a new imaging probe for prostate cancer. Clinical cancer research: an official journal of the American Association for Cancer Research 2008; 14: 3036-3043 DOI: 10.1158/1078-0432.CCR-07-1517.
- 28 Szabo Z, Mena E, Rowe SP. et al. Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Molecular imaging and biology: MIB: the official publication of the Academy of Molecular Imaging 2015; 17: 565-574 DOI: 10.1007/s11307-015-0850-8.
- 29 Cardinale J, Schafer M, Benesova M. et al. Preclinical Evaluation of (18)F-PSMA-1007, a New Prostate-Specific Membrane Antigen Ligand for Prostate Cancer Imaging. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2017; 58: 425-431 DOI: 10.2967/jnumed.116.181768.
- 30 Oh SW, Wurzer A, Teoh EJ. et al. Quantitative and Qualitative Analyses of Biodistribution and PET Image Quality of a Novel Radiohybrid PSMA, (18)F-rhPSMA-7, in Patients with Prostate Cancer. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2020; 61: 702-709 DOI: 10.2967/jnumed.119.234609.
- 31 Zlatopolskiy BD, Endepols H, Krapf P. et al. Discovery of (18)F-JK-PSMA-7, a novel PET-probe for the detection of small PSMA positive lesions. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2018; DOI: 10.2967/jnumed.118.218495.
- 32 2021 https://extranet.edqm.eu/4DLink1/4DCGI/Query_SW?vSelectName=2&vContains=1&vtsubName=psma&SWTP=1&OK=Search
- 33 Afshar-Oromieh A, Debus N, Uhrig M. et al. Impact of long-term androgen deprivation therapy on PSMA ligand PET/CT in patients with castration-sensitive prostate cancer. European journal of nuclear medicine and molecular imaging 2018; 45: 2045-2054 DOI: 10.1007/s00259-018-4079-z.
- 34 Afshar-Oromieh A, Sattler LP, Mier W. et al. The Clinical Impact of Additional Late PET/CT Imaging with (68)Ga-PSMA-11 (HBED-CC) in the Diagnosis of Prostate Cancer. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2017; 58: 750-755 DOI: 10.2967/jnumed.116.183483.
- 35 Derlin T, Weiberg D, von Klot C. et al. (68)Ga-PSMA I&T PET/CT for assessment of prostate cancer: evaluation of image quality after forced diuresis and delayed imaging. European radiology 2016; 26: 4345-4353 DOI: 10.1007/s00330-016-4308-4.
- 36 Afshar-Oromieh A, Malcher A, Eder M. et al. PET imaging with a [68Ga]gallium-labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans and first evaluation of tumour lesions. European journal of nuclear medicine and molecular imaging 2013; 40: 486-495 DOI: 10.1007/s00259-012-2298-2.
- 37 Afshar-Oromieh A, Hetzheim H, Kubler W. et al. Radiation dosimetry of (68)Ga-PSMA-11 (HBED-CC) and preliminary evaluation of optimal imaging timing. European journal of nuclear medicine and molecular imaging 2016; 43: 1611-1620 DOI: 10.1007/s00259-016-3419-0.
- 38 Pfob CH, Ziegler S, Graner FP. et al. Biodistribution and radiation dosimetry of (68)Ga-PSMA HBED CC-a PSMA specific probe for PET imaging of prostate cancer. European journal of nuclear medicine and molecular imaging 2016; 43: 1962-1970 DOI: 10.1007/s00259-016-3424-3.
- 39 Zechmann CM, Afshar-Oromieh A, Armor T. et al. Radiation dosimetry and first therapy results with a (124)I/ (131)I-labeled small molecule (MIP-1095) targeting PSMA for prostate cancer therapy. European journal of nuclear medicine and molecular imaging 2014; 41: 1280-1292 DOI: 10.1007/s00259-014-2713-y.
- 40 Herrmann K, Bluemel C, Weineisen M. et al. Biodistribution and radiation dosimetry for a probe targeting prostate-specific membrane antigen for imaging and therapy. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2015; 56: 855-861 DOI: 10.2967/jnumed.115.156133.
- 41 Afshar-Oromieh A, Hetzheim H, Kratochwil C. et al. 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. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2015; 56: 1697-1705 DOI: 10.2967/jnumed.115.161299.
- 42 Rahbar K, Afshar-Oromieh A, Bogemann M. et al. (18)F-PSMA-1007 PET/CT at 60 and 120 minutes in patients with prostate cancer: biodistribution, tumour detection and activity kinetics. European journal of nuclear medicine and molecular imaging 2018; 45: 1329-1334 DOI: 10.1007/s00259-018-3989-0.
- 43 Wondergem M, van der Zant FM, Knol RJJ. et al. (18)F-DCFPyL PET/CT in the Detection of Prostate Cancer at 60 and 120 Minutes: Detection Rate, Image Quality, Activity Kinetics, and Biodistribution. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2017; 58: 1797-1804 DOI: 10.2967/jnumed.117.192658.
- 44 Referenzwerte Bd. https://www.bfs.de/DE/themen/ion/anwendung-medizin/diagnostik/referenzwerte/referenzwerte_node.html
- 45 Fanti S, Minozzi S, Morigi JJ. et al. Development of standardized image interpretation for 68Ga-PSMA PET/CT to detect prostate cancer recurrent lesions. European journal of nuclear medicine and molecular imaging 2017; 44: 1622-1635 DOI: 10.1007/s00259-017-3725-1.
- 46 European Society of Urogenital Radiology. Guidelines. https://www.esur.org/esur-guidelines/
- 47 Afshar-Oromieh A, Haberkorn U, Schlemmer HP. et al. Comparison of PET/CT and PET/MRI hybrid systems using a 68Ga-labelled PSMA ligand for the diagnosis of recurrent prostate cancer: initial experience. European journal of nuclear medicine and molecular imaging 2014; 41: 887-897 DOI: 10.1007/s00259-013-2660-z.
- 48 Deutsche Röntgengesellschaft. Leitlinien. https://www.drg.de/de-DE/48/leitlinien/
- 49 Barrett JF, Keat N. Artifacts in CT: recognition and avoidance. Radiographics: a review publication of the Radiological Society of North America, Inc 2004; 24: 1679-1691 DOI: 10.1148/rg.246045065.
- 50 Silver DA, Pellicer I, Fair WR. et al. Prostate-specific membrane antigen expression in normal and malignant human tissues. Clinical cancer research: an official journal of the American Association for Cancer Research 1997; 3: 81-85
- 51 Sheikhbahaei S, Afshar-Oromieh A, Eiber M. et al. Pearls and pitfalls in clinical interpretation of prostate-specific membrane antigen (PSMA)-targeted PET imaging. European journal of nuclear medicine and molecular imaging 2017; 44: 2117-2136 DOI: 10.1007/s00259-017-3780-7.
- 52 Afshar-Oromieh A, Sattler LP, Steiger K. et al. Tracer uptake in mediastinal and paraaortal thoracic lymph nodes as a potential pitfall in image interpretation of PSMA ligand PET/CT. European journal of nuclear medicine and molecular imaging 2018; 45: 1179-1187 DOI: 10.1007/s00259-018-3965-8.
- 53 Krohn T, Verburg FA, Pufe T. et al. [(68)Ga]PSMA-HBED uptake mimicking lymph node metastasis in coeliac ganglia: an important pitfall in clinical practice. European journal of nuclear medicine and molecular imaging 2015; 42: 210-214 DOI: 10.1007/s00259-014-2915-3.
- 54 Rischpler C, Beck TI, Okamoto S. et al. (68)Ga-PSMA-HBED-CC Uptake in Cervical, Celiac, and Sacral Ganglia as an Important Pitfall in Prostate Cancer PET Imaging. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2018; 59: 1406-1411 DOI: 10.2967/jnumed.117.204677.
- 55 Giesel FL, Hadaschik B, Cardinale J. et al. F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. European journal of nuclear medicine and molecular imaging 2017; 44: 678-688 DOI: 10.1007/s00259-016-3573-4.
- 56 Huda W, Ogden KM, Khorasani MR. Converting dose-length product to effective dose at CT. Radiology 2008; 248: 995-1003 DOI: 10.1148/radiol.2483071964.
- 57 Krause BJ, Beyer T, Bockisch A. et al. [FDG-PET/CT in oncology. German Guideline]. Nuklearmedizin Nuclear medicine 2007; 46: 291-301 DOI: 10.3413/nukmed-282.
- 58 Szermerski B, Bruchmann I, Behrens R. et al. Dose rate constants for the quantity H(p)(3) for frequently used radionuclides in nuclear medicine. Zeitschrift fur medizinische Physik 2016; 26: 304-310 DOI: 10.1016/j.zemedi.2015.11.003.
- 59 Bruchmann I, Szermerski B, Behrens R. et al. Impact of radiation protection means on the dose to the lens of the eye while handling radionuclides in nuclear medicine. Zeitschrift fur medizinische Physik 2016; 26: 298-303 DOI: 10.1016/j.zemedi.2015.07.002.
- 60 Graham MM, Wahl RL, Hoffman JM. et al. Summary of the UPICT Protocol for 18F-FDG PET/CT Imaging in Oncology Clinical Trials. Journal of nuclear medicine: official publication, Society of Nuclear Medicine 2015; 56: 955-961 DOI: 10.2967/jnumed.115.158402.
- 61 EARL. 18F PET/CT and 18F PET/MR Accreditation. https://earl.eanm.org/18f-pet-ct_pet-mr/
- 62 EARL. 68GA PET/CT Accreditation. https://earl.eanm.org/68ga-pet-ct/
- 63 Leitlinienprogramm Onkologie (Deutsche Krebsgesellschaft, Deutsche Krebshilfe, AWMF): S3-Leitlinie Prostatakarzinom, Langversion 6.2, 2021, AWMF Registernummer: 043/022OL. http://www.leitlinienprogramm-onkologie.de/leitlinien/prostatakarzinom/