The Impact of PSMA PET–Based Eligibility Criteria Used in the Prospective Phase II TheraP Trial in Metastatic Castration-Resistant Prostate Cancer Patients Undergoing Prostate-Specific Membrane Antigen–Targeted Radioligand Therapy
Open accessAbstract
Prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) has shown encouraging results for treatment of metastatic castration-resistant prostate cancer (mCRPC) in the prospective, multicenter, randomized phase II TheraP study. The inclusion criteria for that study comprised a pretherapeutic 68Ga-PSMA-11 PET scan showing sufficient tumor uptake using a predefined threshold and the absence of 18F-FDG–positive, PSMA ligand–negative tumor lesions. However, the prognostic value of these PET-based inclusion criteria remains unclear. Therefore, we evaluated the outcome of mCRPC patients treated with PSMA RLT using TheraP as well as other TheraP-based PET inclusion criteria. Methods: First, patients were dichotomized into 2 groups whose PSMA PET scans did (TheraP contrast-enhanced PSMA [cePSMA] PET–positive) or did not (TheraP cePSMA PET–negative) fulfill the inclusion criteria of TheraP. Notably, unlike in TheraP, 18F-FDG PET was not performed on our patients. Prostate-specific antigen (PSA) response (PSA decline ≥ 50% from baseline), PSA progression-free survival, and overall survival (OS) were compared. Additionally, patients were further dichotomized according to predefined SUVmax thresholds different from those used in TheraP to analyze their potential impact on outcome as well. Results: In total, 107 mCRPC patients were included in this analysis (TheraP cePSMA PET–positive, n = 77; TheraP cePSMA PET–negative, n = 30). PSA response rates were higher in TheraP cePSMA PET–positive patients than in TheraP cePSMA PET–negative patients (54.5% vs. 20%, respectively; P = 0.0012). The median PSA progression-free survival (P = 0.007) and OS (P = 0.0007) of patients were significantly longer in the TheraP cePSMA PET–positive group than in the TheraP cePSMA PET–negative group. Moreover, being in the TheraP cePSMA PET–positive group was identified as a significant prognosticator of longer OS (P = 0.003). The application of different SUVmax thresholds for a single hottest lesion demonstrated no influence on outcome in patients eligible for PSMA RLT. Conclusion: Patient selection for PSMA RLT according to the inclusion criteria of TheraP led to a better treatment response and outcome in our preselected patient cohort. However, a relevant number of patients not fulfilling these criteria also showed substantial rates of response.
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High SUVmean was associated with improved treatment response to 177Lu-PSMA-617 versus cabazitaxel in the phase 2 TheraP study.
“In agreement with our present findings, high SUVmean was associated with improved treatment response to 177Lu-PSMA-617 versus cabazitaxel in the phase 2 TheraP study (7,20).”
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Cites
Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer
Sartor, O., de Bono, J., Chi, K. N., Fizazi, K., Herrmann, K., Rahbar, K., Tagawa, S. T., Nordquist, L. T., Vaishampayan, N., El-Haddad, G., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2107322 · Cited by 2,864 · see citing works
Scher, H. I., Morris, M. J., Stadler, W. M., Higano, C. S., Basch, E., Fizazi, K. S., Antonarakis, E. S., Beer, T. M., Carducci, M. A., Chi, K. N., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2015.64.2702 · Cited by 1,665 · see citing works
Hofman, M. S., Violet, J. A., Hicks, R. J., Ferdinandus, J., Thang, S. P., Akhurst, T. J., Iravani, A., Kong, G., Kumar, A. S. R., Murphy, D. G., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30198-0 · Cited by 1,180 · see citing works
Hofman, M. S., Emmett, L., Sandhu, S., Iravani, A., Joshua, A. M., Goh, J. C., Pattison, D. A., Tan, T. H., Kirkwood, I. D., Ng, S., et al. (2021) · The Lancet · doi:10.1016/s0140-6736(21)00237-3 · Cited by 1,170 · see citing works
Rahbar, K., Ahmadzadehfar, H., Kratochwil, C., Haberkorn, U., Schäfers, M. A., Essler, M., Baum, R. P., Kulkarni, H., Schmidt, M. C., Drzezga, A. E., et al. (2016) · Journal of Nuclear Medicine · doi:10.2967/jnumed.116.183194 · Cited by 849 · see citing works
Violet, J., Jackson, P., Ferdinandus, J., Sandhu, S., Akhurst, T., Iravani, A., Kong, G., Kumar, A. R., Thang, S. P., Eu, P., et al. (2019) · Journal of Nuclear Medicine · doi:10.2967/jnumed.118.219352 · Cited by 504 · see citing works
EANM procedure guidelines for radionuclide therapy with 177Lu-labelled PSMA-ligands (177Lu-PSMA-RLT)
Kratochwil, C., Fendler, W. P., Eiber, M., Baum, R. P., Bozkurt, M. F., Czernin, J. G., Bolton, R. C. D., Ezziddin, S., Forrer, F., Hicks, R. J., et al. (2019) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-019-04485-3 · Cited by 387 · see citing works
Self-citationEder, M., Neels, O. C., Müller, M. J., Bauder‐Wüst, U., Remde, Y., Schäfer, M. K.-H., Hennrich, U., Eisenhut, M., Afshar‐Oromieh, A., Haberkorn, U., et al. (2014) · Pharmaceuticals · doi:10.3390/ph7070779 · Cited by 369 · see citing works
Heck, M. M., Tauber, R., Schwaiger, S., Retz, M. M., D’Alessandria, C., Maurer, T., Gafita, A., Wester, H., Gschwend, J. E., Weber, W., et al. (2018) · European Urology · doi:10.1016/j.eururo.2018.11.016 · Cited by 299 · see citing works
Self-citationGafita, A., Calais, J., Grogan, T. R., Hadaschik, B., Wang, H., Weber, M., Sandhu, S., Kratochwil, C., Esfandiari, R., Tauber, R., et al. (2021) · The Lancet Oncology · doi:10.1016/s1470-2045(21)00274-6 · Cited by 271 · see citing works
Self-citationWeineisen, M., Šimeček, J., Schottelius, M., Schwaiger, M., & Wester, H. (2014) · EJNMMI Research · doi:10.1186/s13550-014-0063-1 · Cited by 181 · see citing works
Seifert, R., Seitzer, K. E., Herrmann, K., Kessel, K., Schäfers, M. A., Kleesiek, J., Weckesser, M., Boegemann, M., & Rahbar, K. (2020) · Theranostics · doi:10.7150/thno.47251 · Cited by 138 · see citing works
Ferdinandus, J., Eppard, E., Gaertner, F. C., Kürpig, S., Fimmers, R., Yordanova, A., Hauser, S., Feldmann, G., Essler, M., & Ahmadzadehfar, H. (2016) · Journal of Nuclear Medicine · doi:10.2967/jnumed.116.178228 · Cited by 129 · see citing works
Michalski, K., Ruf, J., Goetz, C., Seitz, A. K., Buck, A. K., Lapa, C., & Hartrampf, P. E. (2020) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-020-05160-8 · Cited by 121 · see citing works
Kuo, P., Hesterman, J., Rahbar, K., Kendi, A. T., Wei, X. X., Fang, B., Adra, N., Armstrong, A. J., Garje, R., Michalski, J. M., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.2022.40.16_suppl.5002 · Cited by 83 · see citing works
Iravani, A., Violet, J., Azad, A., & Hofman, M. S. (2020) · Prostate Cancer and Prostatic Diseases · doi:10.1038/s41391-019-0174-x · Cited by 68 · see citing works
Hofman, M. S., Emmett, L., Sandhu, S. K., Iravani, A., Joshua, A. M., Goh, J. C. H., Pattison, D. A., Tan, T. H., Kirkwood, I. D., Francis, R. J., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.2022.40.16_suppl.5000 · Cited by 55 · see citing works
Seifert, R., Telli, T., Hadaschik, B. A., Fendler, W. P., Kuo, P. H., & Herrmann, K. (2022) · Journal of Nuclear Medicine · doi:10.2967/jnumed.122.264741 · Cited by 47 · see citing works
Manafi‐Farid, R., Harsini, S., Saidi, B., Ahmadzadehfar, H., Herrmann, K., Briganti, A., Walz, J. C., & Beheshti, M. (2021) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-021-05237-y · Cited by 46 · see citing works
Capobianco, N., Sibille, L., Chantadisai, M., Gafita, A., Langbein, T., Platsch, G., Solari, E. L., Shah, V. P., Spottiswoode, B. S., Eiber, M., et al. (2021) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-021-05473-2 · Cited by 46 · see citing works
Self-citationKarimzadeh, A., Heck, M. M., Tauber, R., Knorr, K., Haller, B., D’Alessandria, C., Weber, W., Eiber, M., & Rauscher, I. (2022) · Journal of Nuclear Medicine · doi:10.2967/jnumed.122.264402 · Cited by 39 · see citing works
Self-citationButeau, J. P., Martin, A. J., Emmett, L., Iravani, A., Sandhu, S. K., Joshua, A. M., Zhang, A. Y., Francis, R. J., Scott, A. M., Azad, A., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.2022.40.6_suppl.010 · Cited by 20 · see citing works
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Research works printed but not linked: 2
- Michalski K, Ruf J, Goetz C, et al. Prognostic implication of dual tracer PET/CT: PSMA ligand and [ 18 F] FDG PET/CT in patients undergoing [ 177 Lu] PSMA radi- oligand therapy. Eur J Nucl Med Mol Imaging. 2021;48:2024-2030.
- Kratochwil C, Fendler WP, Eiber M, et al. EANM procedure guidelines for radio- nuclide therapy with 177 Lu-labelled PSMA-ligands ( 177 Lu-PSMA-RLT). Eur J Nucl Med Mol Imaging. 2019;46:2536-2544.
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Kuo, P. H., Morris, M. J., Hesterman, J., Kendi, A. T., Rahbar, K., Wei, X. X., Fang, B., Adra, N., Garje, R., Michalski, J. M., et al. (2024) · Radiology · doi:10.1148/radiol.233460 · Cited by 119 · see citing works
Demirci, R. A., Ghodsi, A., Gulati, R., Behnia, F., Nelson, P. S., Cheng, H. H., Yezefski, T., Haffner, M. C., Hawley, J. E., Montgomery, B., et al. (2024) · Journal of Nuclear Medicine · doi:10.2967/jnumed.124.268167 · Cited by 24 · see citing works
Al‐Ibraheem, A., Abdlkadir, A. S., Sweedat, D. A., Maus, S., Al-Rasheed, U., Salah, S. H., Khriesh, F., Juaidi, D., Dayek, D. A., Istatieh, F., et al. (2024) · Cancers · doi:10.3390/cancers16111974 · Cited by 23 · see citing works
Slootbeek, P. H. J., Velez, M. V. L., Privé, B. M., van der Doelen, M. J., Kloots, I. S. H., Naga, S. P., Onstenk, H. E., Nagarajah, J., Westdorp, H., van Oort, I. M., et al. (2024) · Theranostics · doi:10.7150/thno.96322 · Cited by 20 · see citing works
Eisazadeh, R., Mirshahvalad, S. A., Schwieghofer-Zwink, G., Hehenwarter, L., Rendl, G., Gampenrieder, S. P., Greil, R., Pirich, C., & Beheshti, M. (2024) · Molecular Imaging and Biology · doi:10.1007/s11307-024-01900-6 · Cited by 16 · see citing works
Tuchayi, A. M., Yadav, S., Jiang, F., Kim, S. T., Saelee, R., Morley, A., Juarez, R., Lawhn-Heath, C. A., Wang, Y., de Kouchkovsky, I., et al. (2024) · Journal of Nuclear Medicine · doi:10.2967/jnumed.123.266842 · Cited by 18 · see citing works
61Cu-PSMA–Targeted PET for Prostate Cancer: From Radiotracer Development to First-in-Human Imaging
Bernabeu, T. B., Mansi, R., Pozzo, L. D., Zanger, S., Gaonkar, R. H., McDougall, L., Rose, F. D., Jaafar-Thiel, L., Herz, M., Eiber, M. J., et al. (2024) · Journal of Nuclear Medicine · doi:10.2967/jnumed.123.267126 · Cited by 16 · see citing works
Self-citationCivelek, A. C. (2026) · Cancers · doi:10.3390/cancers18020234 · Cited by 7 · see citing works
Karimzadeh, A., Soeiro, P., Feuerecker, B., Hecker, C.-S., Knorr, K., Heck, M. M., Tauber, R., D’Alessandria, C., Weber, W., Eiber, M. J., et al. (2023) · Journal of Nuclear Medicine · doi:10.2967/jnumed.123.265878 · Cited by 7 · see citing works
Self-citationNa, S. J., Ha, S., Kim, I.-H., Lee, J. Y., & Joo Hyun, O. (2024) · Korean Journal of Radiology · doi:10.3348/kjr.2024.0439 · Cited by 6 · see citing works
Karimzadeh, A., Lehnert, W., Koehler, D., Shenas, F., Kisters, A., Apostolova, I. I., Klutmann, S., Adam, G., & Sauer, M. (2025) · RöFo - Fortschritte auf dem Gebiet der Röntgenstrahlen und der bildgebenden Verfahren · doi:10.1055/a-2514-4523 · Cited by 3 · see citing works
Self-citationPasha, A. A., Hajiebrahimi, N., Motallebi, N., & Eydi, M. (2025) · Studies in Multidisciplinary Medical Research · doi:10.61882/smmr.202501.07.02 · Cited by 1 · see citing works
177Lu-PSMA for prostate cancer: progress, challenges and future perspectives
Xi, Z., Ji, S., Zhang, Y., Sun, M.-H., Jia, G., & Jiang, Q. (2026) · Asian Journal of Andrology · doi:10.4103/aja2025103 · Cited by 1 · see citing works
Genomic Discoveries: Precision Medicine and Personalized Approaches in Prostate Cancer Care
Bida, M., Mosoane, B., Nonxuba, M., Disenyane, D., Mongan, N. P., & Dlamini, Z. (2024) · Springer eBooks · doi:10.1007/978-3-031-64388-0_4
Karimzadeh, A., Lehnert, W., Koehler, D., Shenas, F., Kisters, A., Apostolova, I. I., Klutmann, S., Adam, G., & Sauer, M. (2025) · Nuklearmedizin - NuclearMedicine · doi:10.1055/a-2654-4048
Self-citationMercier, B., Dréano, L., Neveu, E., Estrade, F., Mathiéu, R., Laguerre, B., Crouzet, L., Broyelle, A., Bouvry, C., Jeune, F. L., et al. (2026) · Annals of Nuclear Medicine · doi:10.1007/s12149-026-02236-7
Dixit, T., Sawardekar, M., Verma, T., Sreeja, P., & Ravindran, S. (2026) · Discover Oncology · doi:10.1007/s12672-026-05554-4
Galnaitienė, G., Simkus, M., Balčiūnaitė, I., Lušaitė, K., Wen, F., Hoffmann, M., Saar, M., Mottaghy, F. M., Vajauskas, D., & Lütje, S. (2026) · Pharmaceuticals · doi:10.3390/ph19071084
Karimzadeh, A., Fütterer, C., Hansen, K., Coban, Ö., Hein, S., Nekolla, S. G., Heck, M., Tauber, R., Haller, B., Gafita, A., et al. (2026) · Journal of Nuclear Medicine · doi:10.2967/jnumed.125.270944
Self-citation
- Authors
- Karimzadeh, A., Heck, M., Tauber, R., Solaris, E., Nekolla, S., Knorr, K., Haller, B., D’Alessandria, C., Weber, W. A., Eiber, M., & Rauscher, I.
- Affiliations
- University Medical Center Hamburg-Eppendorf (DE)
- Technical University of Munich (DE)
- ORCID
- Venue
- Journal of Nuclear Medicine
- Publisher
- Society of Nuclear Medicine
- Published
- 2023-06-08
- Volume
- 64
- Issue
- 8
- Pages
- 1252-1258
- ISSN
- 0161-5505 (ISSN-L)
- 2159-662X
- OpenAlex
- W4379879288
- Cited by
- 19
- References
- 22
- Citations by year
- 2026: 6 · 2025: 3 · 2024: 9 · 2023: 1
- FWCI
- 3.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Nuclear Medicine (publishedVersion)
- PubMed (publishedVersion)
- mediaTUM (Technical University of Munich) (submittedVersion)
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Keywords
- metastatic castration-resistant prostate cancer, PSMA radioligand therapy, SUVmax threshold, prognostic factors, overall survival, PSA response, treatment response prediction
- MeSH terms
- Dipeptides, Heterocyclic Compounds, 1-Ring, Humans, Lutetium, Male, Prospective Studies, Prostate, Retrospective Studies, Treatment Outcome, Prostate-Specific Antigen, Fluorodeoxyglucose F18, Prostatic Neoplasms, Castration-Resistant
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