Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer
Open accessAbstract
BACKGROUND: Lu)-PSMA-617 is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells and the surrounding microenvironment. METHODS: Ra), and investigational drugs. The alternate primary end points were imaging-based progression-free survival and overall survival, which were powered for hazard ratios of 0.67 and 0.73, respectively. Key secondary end points were objective response, disease control, and time to symptomatic skeletal events. Adverse events during treatment were those occurring no more than 30 days after the last dose and before subsequent anticancer treatment. RESULTS: Lu-PSMA-617 than without (52.7% vs. 38.0%), but quality of life was not adversely affected. CONCLUSIONS: Lu-PSMA-617 prolonged imaging-based progression-free survival and overall survival when added to standard care in patients with advanced PSMA-positive metastatic castration-resistant prostate cancer. (Funded by Endocyte, a Novartis company; VISION ClinicalTrials.gov number, NCT03511664.).
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Common adverse events of 177Lu-PSMA-617 plus standard care in the VISION trial included hematologic, gastrointestinal issues, and fatigue.
“Common adverse events included hematologic, gastrointestinal issues, and fatigue.”
From Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation (2024) · cites this paper as [86]
The Results > Safety > Adverse Events section identifies fatigue and nausea, a gastrointestinal symptom, among the most common adverse events in the 177Lu-PSMA-617 group. The passages in our copy do not identify hematologic adverse events as common, so that part of the claim is unsupported. (LLM, conf=0.83)
Experimental — accuracy not yet measuredRadiopharmaceutical therapies are gaining increasing prominence as they improve survival in patients with common diseases such as metastatic prostate cancer.
“R adiopharmaceutical therapies are gaining increasing prominence as they improve survival in patients with common diseases such as metastatic prostate cancer ( 1 , 2 ).”
From Normal-Tissue Tolerance to Radiopharmaceutical Therapies, the Knowns and the Unknowns (2021) · cites this paper as [1]
The Discussion reports that 177Lu-PSMA-617 prolonged overall survival when added to standard care, supporting the survival claim for patients with PSMA-positive metastatic castration-resistant prostate cancer. The paper does not establish that radiopharmaceutical therapies as a class are gaining prominence or improving survival across metastatic prostate cancer more generally. (LLM, conf=0.78)
Experimental — accuracy not yet measuredDespite 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 [1]
The Results > Safety passage reports that dry mouth was common with 177Lu-PSMA-617 and that these adverse events were nearly all grade 1 or 2. It does not establish that xerostomia was usually grade 1 specifically, or assess variability across studies. No page number is available in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measured177Lu-PSMA-617 combined with standard care improves overall survival compared to standard care alone in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
“In the phase III VISION trial, 177Lu-PSMA-617, when combined with standard care, demonstrated a substantial improvement in overall survival and radiographic progression-free survival compared to standard care alone in patients with PSMA-positive mCRPC.”
From Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation (2024) · cites this paper as [86]
177Lu-PSMA-617 combined with standard care improves radiographic progression-free survival compared to standard care alone in patients with PSMA-positive mCRPC.
“In the phase III VISION trial, 177Lu-PSMA-617, when combined with standard care, demonstrated a substantial improvement in overall survival and radiographic progression-free survival compared to standard care alone in patients with PSMA-positive mCRPC.”
From Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation (2024) · cites this paper as [86]
In the VISION trial, median radiographic progression-free survival for 177Lu-PSMA-617 plus standard care was 8.7 months versus 3.4 months for standard care alone.
“The median overall survival increased from 11.3 to 15.3 months, and the median radiographic progression-free survival extended from 3.4 to 8.7 months [86].”
From Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation (2024) · cites this paper as [86]
In the VISION trial, median overall survival for 177Lu-PSMA-617 plus standard care was 15.3 months versus 11.3 months for standard care alone.
“The median overall survival increased from 11.3 to 15.3 months, and the median radiographic progression-free survival extended from 3.4 to 8.7 months [86].”
From Radiopharmaceuticals: navigating the frontier of precision medicine and therapeutic innovation (2024) · cites this paper as [86]
In PSMA-positive mCRPC patients who had exhausted conventional therapies, 177Lu-PSMA-617 plus standard care improved radiographic progression-free survival compared with standard care alone (median 8.7 vs 3.4 months; HR 0.40; P < 0.001).
“and radiographic progression-free survival (rPFS; median 8.7 months vs. 3.4 months; HR: 0.40, P < 0.001) compared to standard of care (SOC) alone.”
From PSMA-based Therapies and Novel Therapies in Advanced Prostate Cancer: The Now and the Future (2025) · cites this paper as [11]
In PSMA-positive mCRPC patients who had exhausted conventional therapies, 177Lu-PSMA-617 plus standard care improved overall survival compared with standard care alone (median 15.3 vs 11.3 months; HR 0.62; P < 0.001).
“Patients receiving 177Lu-PSMA- 617 alongside standard care experienced significant improvements in overall survival (OS; median 15.3 months vs. 11.3 months; hazard ratio [HR]: 0.62, P < 0.001)”
From PSMA-based Therapies and Novel Therapies in Advanced Prostate Cancer: The Now and the Future (2025) · cites this paper as [11]
Approval of novel therapies for mCRPC has resulted in uncertainties on optimal treatment sequencing, and utilization of these treatments is limited, demonstrating the need for improved real-world treatment practices.
“Although improvements in clinical outcomes have been observed with novel therapies [20–31], their approval has resulted in uncertainties on optimal treatment sequencing, and utilization of these treatments is limited, demonstrating the need for improved real-world treatment practices.”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [25]
In the phase 3 VISION trial, treatment with [177Lu]Lu-PSMA-617 plus best SOC (BSOC) prolonged rPFS and OS in patients with PSMA-positive mCRPC who had previously received ≥1 ARPI and 1-2 taxane-based chemotherapy regimens.
“In the phase 3 VISION trial (NCT03511664), treatment with [177Lu]Lu-PSMA-617 plus best SOC (BSOC) prolonged rPFS and OS in patients with PSMA-positive mCRPC who had previously received ≥1 ARPI and 1–2 taxane-based chemotherapy regimens [25].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [25]
In the VISION trial, 12.6% of patients did not meet eligibility criteria based on PSMA imaging.
“Some patients will have PSMA-negative disease and will not be candidates for PSMA-targeted therapy; in the VISION trial, 12.6% of patients did not meet eligibility criteria based on PSMA imaging [25].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [25]
These results complement the previously reported primary efficacy endpoints of prolonged radiographic progression-free survival and extended overall survival with 177Lu-PSMA-617 in the VISION trial.
“These results complement the previously reported primary efficacy endpoints of prolonged rPFS and extended OS with 177Lu-PSMA-617 in the VISION trial.12”
VISION was an open-label, international, randomised phase 3 trial of the efficacy and safety of 177Lu-PSMA-617 in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer previously treated with at least one androgen receptor pathway inhibitor and one or two taxane-containing regimens.
“VISION was an open-label, international, randomised phase 3 trial of the efficacy and safety of 177Lu-PSMA-617 in patients with progressive PSMA-positive mCRPC previously treated with at least one ARPI and one or two taxane-containing regimens, as previously described.12”
In VISION, the median time to first symptomatic skeletal event or death was delayed in the 177Lu-PSMA-617 group versus control, and spinal cord compression, the most deleterious symptomatic skeletal event, was numerically less frequent.
“In VISION, the median time to first SSE or death was delayed in the 177Lu-PSMA-617 group versus control,12 and spinal cord compression, the most deleterious SSE, was numerically less frequent.”
The impact of the high early drop-out rate in the control group was mitigated by analysing health-related quality of life and pain outcomes in the PFS analysis set.
“The impact of the high early drop-out rate in the control group was mitigated by analysing HRQoL and pain outcomes in the PFS analysis set, comprising patients who were randomised after the implementation of measures that reduced the drop-out rate in the control group.12”
Prespecified VISION analysis showed time to worsening in FACT-P total score favored addition of 177Lu-PSMA-617 to standard of care (HR 0.54; 95% CI 0.45, 0.66).
“Top-level prespecified HRQoL and pain results from VISION have been briefly reported, with time to worsening in Functional Assessment of Cancer Therapy–Prostate (FACT-P) total score (HR, 0·54; 95% CI: 0·45, 0·66) and Brief Pain Inventory–Short Form (BPI-SF) pain intensity score (HR, 0·52; 95% CI: 0·42, 0·63) favoring the addition of 177Lu-PSMA-617 to SoC.12”
Prespecified VISION analysis showed time to worsening in BPI-SF pain intensity score favored addition of 177Lu-PSMA-617 to standard of care (HR 0.52; 95% CI 0.42, 0.63).
“Top-level prespecified HRQoL and pain results from VISION have been briefly reported, with time to worsening in Functional Assessment of Cancer Therapy–Prostate (FACT-P) total score (HR, 0·54; 95% CI: 0·45, 0·66) and Brief Pain Inventory–Short Form (BPI-SF) pain intensity score (HR, 0·52; 95% CI: 0·42, 0·63) favoring the addition of 177Lu-PSMA-617 to SoC.12”
Adverse events in the "myelosuppression" and "renal effects" groupings were more frequent during randomised treatment with 177Lu-PSMA-617 plus standard of care than with standard of care alone, but were mainly low-grade.
“Adverse events in the “myelosuppression” and “renal effects” groupings were more frequent during randomised treatment with 177Lu-PSMA-617 plus Soc than with SoC alone, but were mainly low-grade.12”
In VISION, 177Lu-PSMA-617 improved radiographic progression-free survival and overall survival when added to protocol-permitted standard of care in patients with metastatic castration-resistant prostate cancer.
“In VISION, the prostate-specific membrane antigen (PSMA)-targeted radioligand therapy lutetium (177Lu) vipivotide tetraxetan ([177Lu]Lu-PSMA-617; 177Lu-PSMA-617) improved radiographic progression-free survival and overall survival when added to protocol-permitted standard of care (SoC) in patients with metastatic castration-resistant prostate cancer (mCRPC).”
Patient-reported outcomes and symptomatic skeletal events were analysed according to assigned treatment group in the PFS analysis set, comprising patients randomised on or after March 5, 2019.
“PROs and SSEs were analysed according to assigned treatment group in the PFS analysis set, comprising patients who were randomised after implementation of the measures designed to reduce the drop-out rate in the control group (on or after March 5, 2019).”
In the phase 3 VISION trial, addition of 177Lu-PSMA-617 to protocol-permitted standard of care prolonged radiographic progression-free survival and overall survival in participants with PSMA-positive metastatic castration-resistant prostate cancer.
“In the phase 3 VISION trial, addition of 177Lu-PSMA-617 to protocol-permitted standard of care (SOC) prolonged radiographic progression-free survival (rPFS) and overall survival (OS) in participants with PSMA-positive mCRPC (8).”
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“The median over-all survival increased from 11.3 to 15.3 months, and the median radiographic progression-free survival extended from 3.4 to 8.7 months [86].”
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PSMA-based Therapies and Novel Therapies in Advanced Prostate Cancer: The Now and the Future
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“Of note, cabazitaxel was not allowed in the SOC arm [11].”
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Imaging and therapy in prostate cancer using prostate specific membrane antigen radioligands
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- Authors
- 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., Park, C. H., Beer, T. M., Armour, A., Pérez-Contreras, W. J., DeSilvio, M., Kpamegan, E., Gericke, G., Messmann, R. A., Morris, M. J., & Krause, B. J.
- Affiliations
- Tulane University (US)
- From the School of Medicine, Tulane University, New Orleans (O.S.); the Institute of Cancer Research and Royal Marsden Hospital, London (J.B.); the British Columbia Cancer Agency, Vancouver, Canada (K.N.C.); Gustave Roussy Institute, Paris-Saclay University, Villejuif, France (K.F.); the University of Duisberg–Essen and German Cancer Consortium, University Hospital Essen, Essen (K.H.), University Hospital Münster, Münster (K.R.), and Rostock University Medical Center, Rostock (B.J.K.) — all in Germany; Weill Cornell Medicine (S.T.T.) and Memorial Sloan Kettering Cancer Center (M.J.M.) — both in New York; the Urology Cancer Center, Omaha, NE (L.T.N.); the School of Medicine, Wayne State University, Detroit (N.V.); Moffitt Cancer Center and Research Institute, Tampa, FL (G.E.-H.); Norton Cancer Institute, Louisville, KY (C.H.P.); Knight Cancer Institute, Oregon Health and Science University, Portland (T.M.B.); Endocyte (a Novartis company), West Lafayette, IN (A.A.); Novartis Pharmaceuticals, East Hanover, N...
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-09-16
- Volume
- 385
- Issue
- 12
- Pages
- 1091-1103
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC8446332
- OpenAlex
- W3176208875
- Cited by
- 2,864
- References
- 34
- Citations by year
- 2026: 685 · 2025: 615 · 2024: 571 · 2023: 506 · 2022: 379 · 2021: 105 · 2014: 1 · 2012: 1
- FWCI
- 206.20
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Funders
- Endocyte, Inc., a Novartis Company
- Advanced Accelerator Applications, a Novartis company
- 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-617, radioligand therapy, PSMA-positive prostate cancer, metastatic castration-resistant prostate cancer, overall survival, quality of life
- MeSH terms
- Aged, Aged, 80 and over, Combined Modality Therapy, Dipeptides, Heterocyclic Compounds, 1-Ring, Humans, Kallikreins, Lutetium, Male, Middle Aged, Prostate, Radioisotopes, Survival Analysis, Prostate-Specific Antigen, Positron-Emission Tomography, Prostatic Neoplasms, Castration-Resistant
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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.
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