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Tumor dosimetry of [177Lu]Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer: Results from the VISION trial sub-study.
Abstract
5046 Background: In VISION, lutetium (177 Lu) vipivotide tetraxetan ([177 Lu]Lu-PSMA-617; 177 Lu-PSMA-617) plus protocol-permitted standard of care (SoC) significantly improved overall survival and radiographic progression-free survival compared with SoC alone, in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. In a VISION dosimetry sub-study, 177 Lu-PSMA-617 had a good safety profile with low radiotoxicity in at-risk organs. Here, we estimated the dosimetry of tumors after administration of 177 Lu-PSMA-617. Methods: The VISION sub-study was performed in a separate cohort of 29 non-randomized participants at four sites in Germany. Eligible patients received 177 Lu-PSMA-617 (7.4 GBq every 6 weeks, ≤ 6 cycles) plus SoC. Patients underwent single-photon emission computed tomography/computed tomography (SPECT/CT) scans at approximately 2, 24, 48 and 168 hours after the first administration of 177 Lu-PSMA-617 (Cycle 1). Up to five tumors in each patient were selected according to tumor size and relative activity uptake. Tumor delineation, volume and morphology were determined using positron emission tomography (PET)/CT images. Kinetic (time-activity) data was determined using SPECT images and the application of phantom derived recovery coefficients. Tumor dosimetry was estimated using the standard Medical Internal Radiation Dose/Radiation Dose Assessment Resource (MIRD/RADAR) method for internal dosimetry. S-values were determined using CT-derived tumor volumes and tissue type as input to the Internal Dose Assessed by Computer (IDAC-Dose) 2.1 program. Tumor dosimetry estimates were reported as absorbed dose per unit activity (Gy/GBq) and cumulative estimated absorbed dose (Gy) over all 6 cycles (44.4 GBq cumulative activity). Results: In total, 104 tumors were analyzed after administration of 177 Lu-PSMA-617 in Cycle 1. Tumor sites included bone (n = 84), lymphatic tissue (n = 18), lung tissue (n = 1) and soft tissue (n = 1). Mean tumor mass by site was 14.6 (standard deviation [SD], 29.8; range, 0.49–224) g for bone and 12.5 (15.9; 0.68–60.7) g for lymphatic tissue. The mean radiation-absorbed dose for all tumors was 6.5 (SD, 8.4; range, 0.13–55) Gy/GBq, and the median absorbed dose was 4.4 Gy/GBq. The mean radiation-absorbed dose by tumor site was 5.4 (SD, 6.0; range, 0.13–45) Gy/GBq for bone and 9.7 (12; 0.99–55) Gy/GBq for lymphatic tissue. The 6-cycle cumulative estimated absorbed dose for all tumors was 287 (SD, 373; range, 5.7–2432) Gy. The 6-cycle cumulative estimated absorbed dose by tumor site was 240 (SD, 268; range, 5.7–2010) Gy for bone and 429 (549; 44–2432) Gy for lymphatic tissue. Conclusions: Tumor dosimetry estimates after administration of 177 Lu-PSMA-617 in the VISION sub-study patient population were consistent with previously published estimates. Clinical trial information: NCT03511664 .
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High SUVmean values indicate high average PSMA expression levels.
“High SUVmean values indicate high average PSMA expression levels, which may promote tumor binding and uptake of 177Lu-PSMA-617, leading to greater delivery of radiation and greater antitumor activity (18,19).”
From Quantitative 68 Ga-PSMA-11 PET and Clinical Outcomes in Metastatic Castration-resistant Prostate Cancer Following 177 Lu-PSMA-617 (VISION Trial) (2024) · cites this paper as [18]
High average PSMA expression may promote tumor binding and uptake of 177Lu-PSMA-617, leading to greater delivery of radiation and greater antitumor activity.
“High SUVmean values indicate high average PSMA expression levels, which may promote tumor binding and uptake of 177Lu-PSMA-617, leading to greater delivery of radiation and greater antitumor activity (18,19).”
From Quantitative 68 Ga-PSMA-11 PET and Clinical Outcomes in Metastatic Castration-resistant Prostate Cancer Following 177 Lu-PSMA-617 (VISION Trial) (2024) · cites this paper as [18]
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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
“High SUV mean values indicate high average PSMA expression levels, which may promote tumor binding and uptake of 177 Lu-PSMA-617, leading to greater delivery of radiation and greater antitumor activity (18,19).”
Self-citationElls, Z., Grogan, T., Czernin, J. G., Dahlbom, M., & Calais, J. (2024) · Journal of Nuclear Medicine · doi:10.2967/jnumed.124.267452 · Cited by 73
Prostate Cancer Radioligand Therapy: PSMA and Beyond, Current Landscape and Future Directions
Bent, E. H., & Morris, M. J. (2025) · Current Oncology Reports · doi:10.1007/s11912-025-01686-y · Cited by 16
“…calculation of radiation dose is an area of ongoing study, but lesion-level dosimetry approaches have shown differences in absorbed tumor radiation dose that vary by an order of magnitude or more between patients and tumors and that the absorbed dose correlates with PSA50 response [36, 53–55].”
Self-citationBodei, L., Tuttle, R. M., Grewal, R. K., Mauguen, A., Augensen, F., Abusamra, M., Mahajan, S., Jayaprakasam, V. S., Osborne, J. R., Haque, S. S., et al. (2023) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-023-06420-z · Cited by 12
“Recently, the dosimetric results of the VISION trial sub-study were presented, indicating mean absorbed doses of 5.4 (range, 0.13–45) Gy/GBq for bone and 9.7 (0.99–55) Gy/GBq for nodes, in line with prior literature [12].”
InfluentialFitzpatrick, K. J., Mikell, J. K., Roseland, M. E., Niedbala, J., Suresh, K., Peterson, A., Viglianti, B. L., Wong, K. K., Frey, K. A., & Dewaraja, Y. K. (2025) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2025.06.3869 · Cited by 6
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“…dose was only 0.37 ± 0.29 Gy/GBq, substantially lower than doses typically associated with clinical efficacy in estab - lished radioligand therapies, where mean tumor doses of 7.6 Gy/GBq for [¹⁷⁷Lu]Lu-DOTATATE (NETTER-1 trial) [38 ], and 6.5 Gy/GBq for [¹⁷⁷Lu]Lu-PSMA-617 (VISION trial) [39].”
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177Lu-PSMA dosimetry made easy: from theory to practical implementation
Moghrabi, S., CHUAMSAAMARKKEE, K., Abdlkadir, A. S., Ruzzeh, S., Estrada-Lobato, E., Juaidi, D., Fayad, H. J., Bautista-Peñalosa, P. A., Shagera, Q. A., & Al‐Ibraheem, A. (2026) · The Quarterly Journal of Nuclear Medicine and Molecular Imaging · doi:10.23736/s1824-4785.26.03695-2 · Cited by 2
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“A small number of tumours can be sufficient, e.g. as in studies where up to five index lesions were selected [24, 25].”
Metadata
- Authors
- Krause, B. J., Chi, K. N., Sartor, A. O., Fizazi, K., Morris, M. J., De Bono, J. S., Tagawa, S. T., Herrmann, K., Kurth, J., Eiber, M., Lassmann, M., Jentzen, W., Sparks, R., Baca, N., Nguyen, Q., Blumenstein, L., Klein, P., Wilke, C., Basque, J.-R., & Rahbar, K.
- Affiliations
- Universitätsmedizin Rostock (DE)
- Vancouver Prostate Centre (CA)
- Tulane Cancer Center, Tulane University School of Medicine, New Orleans, LA
- Université Paris-Saclay (FR)
- Memorial Sloan Kettering Cancer Center (US)
- The Institute of Cancer Research and The Royal Marsden Hospital, London, United Kingdom
- NewYork–Presbyterian Hospital (US)
- Essen University Hospital (DE)
- Technical University of Munich (DE)
- University of Würzburg (DE)
- CDE Dosimetry Services, Knoxville, TN
- CDE Dosimetry Services, Inc., Knoxville, TN
- Novartis Institutes for BioMedical Research (CH)
- Novartis Institutes for BioMedical Research, East Hanover, NJ
- Novartis (Switzerland) (CH)
- University Hospital Münster (DE)
- ORCID
- Venue
- Journal of Clinical Oncology
- Published
- 2023-06-01
- Volume
- 41
- Issue
- 16_suppl
- Pages
- 5046-5046
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4379335339
- Cited by
- 11
- References
- 0
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 2 · 2023: 1
- Type
- conference abstract
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- Funders
- Advanced Accelerator Applications, a Novartis Company
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
- Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
- Keywords
- 177Lu-PSMA-617, tumor dosimetry, metastatic castration-resistant prostate cancer, PSMA-positive prostate cancer, internal dosimetry, absorbed dose, time-activity curves, S-values, bone metastasis, VISION trial, radiotoxicity, radionuclide therapy
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