[177Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial
Abstract
Background Lutetium-177 [ 177 Lu]Lu-PSMA-617 is a radiolabelled small molecule that delivers β radiation to cells expressing prostate-specific membrane antigen (PSMA), with activity and safety in patients with metastatic castration-resistant prostate cancer. We aimed to compare [ 177 Lu]Lu-PSMA-617 with cabazitaxel in patients with metastatic castration-resistant prostate cancer. Methods We did this multicentre, unblinded, randomised phase 2 trial at 11 centres in Australia. We recruited men with metastatic castration-resistant prostate cancer for whom cabazitaxel was considered the next appropriate standard treatment. Participants were required to have adequate renal, haematological, and liver function, and an Eastern Cooperative Oncology Group performance status of 0-2. Previous treatment with androgen receptor-directed therapy was allowed. Men underwent gallium-68 [ 68 Ga]Ga-PSMA-11 and 2-flourine-18[ 18 F]fluoro-2-deoxy-D-glucose (FDG) PET-CT scans. PET eligibility criteria for the trial were PSMA-positive disease, and no sites of metastatic disease with discordant FDG-positive and PSMA-negative findings. Men were randomly assigned (1:1) to [ 177 Lu]Lu-PSMA-617 (6·0-8·5 GBq intravenously every 6 weeks for up to six cycles) or cabazitaxel (20 mg/m 2 intravenously every 3 weeks for up to ten cycles). The primary endpoint was prostate-specific antigen (PSA) response defined by a reduction of at least 50% from baseline. This trial is registered with ClinicalTrials.gov, NCT033…
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Despite variability in the rate of xerostomia among studies, observations have typically been of low severity, usually grade 1 CTCAE.
“Despite variability in the rate of xerostomia among studies, observations have typically been of low severity, usually grade 1 CTCAE ( 1 , 63 ).”
From Normal-Tissue Tolerance to Radiopharmaceutical Therapies, the Knowns and the Unknowns (2021) · cites this paper as [63]
In the randomized phase 2 TheraP trial, treatment with [177Lu]Lu-PSMA-617 compared with cabazitaxel had fewer grade ≥3 adverse events, improved patient-reported outcomes, and yielded similar OS benefit, which may support the use of [177Lu]Lu-PSMA-617 prior to cabazitaxel.
“In the randomized phase 2 TheraP trial (NCT03392428) treatment with [177Lu]Lu-PSMA-617 compared with cabazitaxel had fewer grade ≥3 adverse events, improved patient-reported outcomes, and yielded similar OS benefit, which may support the use of [177Lu]Lu-PSMA-617 prior to cabazitaxel [71].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [71]
Cites
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534 · see citing works
Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Tannock, I. F., de Wit, R., Berry, W. R., Horti, J., Pluzanska, A., Chi, K. N., Oudard, S., Théodore, C., James, N. D., Turesson, I., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa040720 · Cited by 5,735 · see citing works
Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Scher, H. I., Fizazi, K., Saad, F., Taplin, M.-E., Sternberg, C. N., Miller, K., de Wit, R., Mulders, P., Chi, K. N., Shore, N. D., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1207506 · Cited by 4,586 · see citing works
Abiraterone and Increased Survival in Metastatic Prostate Cancer
de Bono, J. S., Logothetis, C. J., Molina, A., Fizazi, K., North, S., Chu, L., Chi, K. N., Jones, R. J., Goodman, O. B., Saad, F., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1014618 · Cited by 4,407 · see citing works
de Bono, J. S., Oudard, S., Ozguroglu, M., Hansen, S., Machiels, J.-P., Kocak, I., Gravis, G., Bodrogi, I., Mackenzie, M. J., Shen, L., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(10)61389-x · Cited by 3,318 · 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 1,184 · see citing works
Self-citationCabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer
de Wit, R., Bono, J. S. D., Sternberg, C. N., Fizazi, K. S., TOMBAL, B. F., Wülfing, C., Kramer, G., Eymard, J., Bamias, A., Carles, J., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1911206 · Cited by 666 · see citing works
Gillessen, S., Attard, G., Beer, T. M., Beltran, H., Bossi, A., Bristow, R. G., Carver, B. S., Castellano, D., Chung, B. H., Clarke, N. W., et al. (2017) · European Urology · doi:10.1016/j.eururo.2017.06.002 · Cited by 645 · see citing works
Self-citationKratochwil, C., Giesel, F. L., Stefanova, M., Benešová, M., Bronzel, M., Afshar-Oromieh, A., Mier, W., Eder, M., Kopka, K., & Haberkorn, U. (2016) · Journal of Nuclear Medicine · doi:10.2967/jnumed.115.171397 · Cited by 636 · see citing works
Gillessen, S., Attard, G., Beer, T. M., Beltran, H., Bjartell, A. S., Bossi, A., Briganti, A., Bristow, R. G., Chi, K. N., Clarke, N. W., et al. (2020) · European Urology · doi:10.1016/j.eururo.2020.01.012 · Cited by 394 · see citing works
Self-citationHeck, 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
Violet, J., Sandhu, S., Iravani, A., Ferdinandus, J., Thang, S.-P., Kong, G., Kumar, A. R., Akhurst, T., Pattison, D., Beaulieu, A., et al. (2020) · Journal of Nuclear Medicine · doi:10.2967/jnumed.119.236414 · Cited by 292 · see citing works
Self-citationRahbar, K., Schmidt, M. C., Heinzel, A., Eppard, E., Bode, A., Yordanova, A., Claesener, M., & Ahmadzadehfar, H. (2016) · Journal of Nuclear Medicine · doi:10.2967/jnumed.116.173757 · Cited by 213 · see citing works
Emmett, L., Crumbaker, M., Ho, B., Willowson, K. P., Eu, P., Ratnayake, L., Epstein, R. J., Blanksby, A., Horvath, L. G., Guminski, A. D., et al. (2018) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2018.09.014 · Cited by 187 · see citing works
Self-citationThang, S. P., Violet, J., Sandhu, S., Iravani, A., Akhurst, T., Kong, G., Ravi Kumar, A., Murphy, D. G., Williams, S. G., Hicks, R. J., et al. (2019) · European Urology Oncology · doi:10.1016/j.euo.2018.11.007 · Cited by 183 · see citing works
Self-citationHofman, M. S., Emmett, L., Violet, J. A., Zhang, A. Y., Lawrence, N. J., Stockler, M. R., Francis, R. J., Iravani, A., Williams, S., Azad, A., et al. (2019) · British Journal of Urology · doi:10.1111/bju.14876 · Cited by 165 · see citing works
Self-citationBailey, D. L., Hofman, M. S., Forwood, N. J., O'Keefe, G. J., Scott, A. M., van Wyngaardt, W. M., Howe, B., Kovacev, O., & Francis, R. J. (2018) · Journal of Nuclear Medicine · doi:10.2967/jnumed.117.202861 · Cited by 55 · see citing works
Self-citationWIDEN: A tool for medical image management in multicenter clinical trials
Chauvie, S., Biggi, A., Stancu, A., Cerello, P., Cavallo, A., Fallanca, F., Ficola, U., Gregianin, M., Guerra, U. P., Chiaravalloti, A., et al. (2014) · Clinical Trials · doi:10.1177/1740774514525690 · Cited by 30 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
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
Morris, M. J., Castellano, D., Herrmann, K., de Bono, J. S., Shore, N. D., Chi, K. N., Crosby, M., Piulats, J. M., Fléchon, A., Wei, X. X., et al. (2024) · The Lancet · doi:10.1016/s0140-6736(24)01653-2 · Cited by 362 · see citing works
Buteau, J. P., Martin, A. J., Emmett, L., Iravani, A., Sandhu, S., Joshua, A. M., Francis, R. J., Zhang, A. Y., Scott, A. M., Lee, S.-T., et al. (2022) · The Lancet Oncology · doi:10.1016/s1470-2045(22)00605-2 · Cited by 296 · 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-citationHofman, M. S., Emmett, L., Sandhu, S., Iravani, A., Buteau, J. P., Joshua, A. M., Goh, J. C., Pattison, D. A., Tan, T. H., Kirkwood, I. D., et al. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(23)00529-6 · Cited by 230 · see citing works
Self-citationSathekge, M. M., Lawal, I. O., Bal, C., Bruchertseifer, F., Ballal, S., Cardaci, G., Davis, C., Eiber, M., Hekimsoy, T., Knoesen, O., et al. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(23)00638-1 · Cited by 210 · see citing works
Biological determinants of PSMA expression, regulation and heterogeneity in prostate cancer
Bakht, M. K., & Beltran, H. (2025) · Nature Reviews Urology · doi:10.1038/s41585-024-00900-z · Cited by 158 · see citing works
Gillessen, S., Armstrong, A., Attard, G., Beer, T. M., Beltran, H., Bjartell, A., Bossi, A., Briganti, A., Bristow, R. G., Bulbul, M., et al. (2022) · European Urology · doi:10.1016/j.eururo.2022.04.002 · Cited by 130 · see citing works
Self-citationRadiotheranostics in oncology: Making precision medicine possible
Aboagye, E. O., Barwick, T. D., & Haberkorn, U. (2023) · CA: A Cancer Journal for Clinicians · doi:10.3322/caac.21768 · Cited by 131 · see citing works
Fizazi, K., Herrmann, K., Krause, B. J., Rahbar, K., Chi, K. N., Morris, M. J., Sartor, O., Tagawa, S. T., Kendi, A. T., Vogelzang, N., et al. (2023) · The Lancet Oncology · doi:10.1016/s1470-2045(23)00158-4 · Cited by 125 · see citing works
Normal-Tissue Tolerance to Radiopharmaceutical Therapies, the Knowns and the Unknowns
Wahl, R. L., Sgouros, G., Iravani, A., Jacene, H., Pryma, D., Saboury, B., Capala, J., & Graves, S. A. (2021) · Journal of Nuclear Medicine · doi:10.2967/jnumed.121.262751 · Cited by 95 · see citing works
Self-citationSathekge, M., Bruchertseifer, F., Vorster, M., Lawal, I. O., Knoesen, O., Mahapane, J., Davis, C., Mdlophane, A., Maes, A., Mokoala, K., et al. (2022) · Journal of Nuclear Medicine · doi:10.2967/jnumed.121.263618 · Cited by 81 · see citing works
Tagawa, S. T., Thomas, C., Sartor, A. O., Sun, M., Stangl-Kremser, J., Bissassar, M., Vallabhajosula, S., Castellanos, S. H., Nauseef, J. T., Sternberg, C. N., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.23.00573 · Cited by 78 · see citing works
Muniz, M., Loprinzi, C. L., Orme, J. J., Koch, R. M., Mahmoud, A. M., Kase, A. M., Riaz, I. B., Andrews, J. R., Thorpe, M. P., Johnson, G. B., et al. (2024) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2024.102748 · Cited by 35 · see citing works
McManus, H. D., Dorff, T., Morgans, A. K., Sartor, O., Shore, N., & Armstrong, A. J. (2025) · Prostate Cancer and Prostatic Diseases · doi:10.1038/s41391-024-00906-z · Cited by 32 · see citing works
Theranostics in Hematooncology
Buck, A. K., Serfling, S. E., Kraus, S., Samnick, S., Dreher, N., Higuchi, T., Rasche, L., Einsele, H., & Werner, R. A. (2023) · Journal of Nuclear Medicine · doi:10.2967/jnumed.122.265199 · Cited by 25 · see citing works
Karimzadeh, A., Heck, M., Tauber, R., Solaris, E., Nekolla, S., Knorr, K., Haller, B., D’Alessandria, C., Weber, W. A., Eiber, M., et al. (2023) · Journal of Nuclear Medicine · doi:10.2967/jnumed.122.265346 · Cited by 19 · see citing works
Mattana, F., Muraglia, L., Barone, A., Colandrea, M., Saker Diffalah, Y., Provera, S., Cascio, A. S., Omodeo Salè, E., & Ceci, F. (2024) · Cancers · doi:10.3390/cancers16091643 · Cited by 16 · see citing works
Erdogan, M., Sengul, S. S., Cetin, B., Avcı, M., Yagci, S., Ozkoç, I., Barikan, D. E., & Yildiz, M. (2022) · Annals of Nuclear Medicine · doi:10.1007/s12149-022-01739-3 · Cited by 14 · see citing works
Imaging and therapy in prostate cancer using prostate specific membrane antigen radioligands
Naik, M., Khan, S. R., Lewington, V., Challapalli, A., Eccles, A., & Barwick, T. D. (2024) · British Journal of Radiology · doi:10.1093/bjr/tqae092 · Cited by 10 · see citing works
- Authors
- 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., Francis, R. J., Gedye, C., Rutherford, N. K., Weickhardt, A., Scott, A. M., Lee, S.-T., Kwan, E. M., Azad, A. A., Ramdave, S., Redfern, A. D., Macdonald, W., Guminski, A., Hsiao, E., Chua, W., Lin, P., Zhang, A. Y., McJannett, M. M., Stockler, M. R., Violet, J. A., Williams, S. G., Martin, A. J., Davis, I. D., Azad, A. A., Chua, W., Davis, I. D., Dhiantravan, N., Emmett, L., Ford, K., Hofman, M. S., Francis, R. J., Gedye, C., Goh, J. C., Guminski, A., Hsiao, E., Iravani, A., Joshua, A. M., Kirkwood, I. D., Langford, A., Lawrence, N., Lee, S.-T., Lin, P., Martin, A. J., McDonald, W., McJannett, M. M., Ng, S., Pattison, D. A., Ramdave, S., Rana, N., Redfern, A. D., Rutherford, N. K., Sandhu, S., Scott, A. M., Stockler, M. R., Subramaniam, S., Tan, T. H., Violet, J. A., Weickhardt, A., Williams, S. G., Yip, S., & Zhang, A. Y.
- Affiliations
- Monash Health (AU)
- Fiona Stanley Hospital (AU)
- Hunter New England Local Health District (AU)
- The University of Melbourne (AU)
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2021-02
- Volume
- 397
- Issue
- 10276
- Pages
- 797-804
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W3130934287
- Cited by
- 1,170
- References
- 19
- Citations by year
- 2026: 210 · 2025: 226 · 2024: 202 · 2023: 212 · 2022: 193 · 2021: 126
- FWCI
- 96.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion)
- Funders
- Endocyte
- Movember Foundation
- Prostate Cancer Foundation of Australia
- 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
- lutetium-177, PSMA-targeted therapy, cabazitaxel, metastatic castration-resistant prostate cancer, prostate-specific membrane antigen, PSA response, PSMA PET imaging, FDG-PET, radioligand therapy, treatment safety
- MeSH terms
- Positron Emission Tomography Computed Tomography, Aged, Antigens, Surface, Dipeptides, Heterocyclic Compounds, 1-Ring, Humans, Lutetium, Male, Radioisotopes, Treatment Outcome, Prostate-Specific Antigen, Glutamate Carboxypeptidase II, Taxoids, Administration, Intravenous, Prostatic Neoplasms, Castration-Resistant
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
