Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

Fizazi, Karim; Herrmann, Ken; Krause, Bernd J; Rahbar, Kambiz; Chi, Kim N; Morris, Michael J; Sartor, Oliver; Tagawa, Scott T; Kendi, Ayse T; Vogelzang, Nicholas; Calais, Jeremie; Nagarajah, James; Wei, Xiao X; Koshkin, Vadim S; Beauregard, Jean-Mathieu; Chang, Brian; Ghouse, Ray; DeSilvio, Michelle; Messmann, Richard A; de Bono, Johann

doi:10.1016/s1470-2045(23)00158-4

Cited by 125Prostate Cancer Treatment and ResearchRadiopharmaceutical Chemistry and ApplicationsProstate Cancer Diagnosis and Treatment

Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

Open access

Fizazi, Karim, Herrmann, Ken, Krause, Bernd J, Rahbar, Kambiz, Chi, Kim N, Morris, Michael J, Sartor, Oliver, Tagawa, Scott T +12 more·2023·The Lancet Oncology

DOI 10.1016/s1470-2045(23)00158-4PMC PMC10641914

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Abstract

Background In VISION, the prostate-specific membrane antigen (PSMA)-targeted radioligand therapy lutetium-177 [177 Lu]Lu-PSMA-617 (vipivotide tetraxetan) improved radiographic progression-free survival and overall survival when added to protocol-permitted standard of care in patients with metastatic castration-resistant prostate cancer. Here, we report additional health-related quality of life (HRQOL), pain, and symptomatic skeletal event results.Methods This multicentre, open-label, randomised, phase 3 trial was conducted at 84 cancer centres in nine countries in North America and Europe. Eligible patients were aged 18 years or older; had progressive PSMA-positive metastatic castration-resistant prostate cancer; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; and had previously received of at least one androgen receptor pathway inhibitor and one or two taxane-containing regimens. Patients were randomly assigned (2:1) to receive either [177 Lu]Lu-PSMA-617 plus protocol-permitted standard of care ([177 Lu]Lu-PSMA-617 group) or standard of care alone (control group) using permuted blocks. Randomisation was stratified by baseline lactate dehydrogenase concentration, liver metastases, ECOG performance status, and androgen receptor pathway inhibitor inclusion in standard of care. Patients in the [177 Lu]Lu-PSMA-617 group received intravenous infusions of 7·4 gigabecquerel (GBq; 200 millicurie [mCi]) [177 Lu]Lu-PSMA-617 every 6 weeks for four cycles plus two optional additional cycles. Standard of care included approved hormonal treatments, bisphosphonates, and radiotherapy. The alternate primary endpoints were radiographic progression-free survival and overall survival, which have been reported. Here we report the key secondary endpoint of time to first symptomatic skeletal event, and other secondary endpoints of HRQOL assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-5L, and pain assessed with the Brief Pain Inventory-Short Form (BPI-SF). Patient-reported outcomes and symptomatic skeletal events were analysed in all patients who were randomly assigned after implementation of measures designed to reduce the dropout rate in the control group (on or after March 5, 2019), and safety was analysed according to treatment received in all patients who received at least one dose of treatment. This trial is registered with ClinicalTrials.gov, NCT03511664, and is active but not recruiting.Findings Between June 4, 2018, and Oct 23, 2019, 831 patients were enrolled, of whom 581 were randomly assigned to the [177 Lu]Lu-PSMA-617 group (n=385) or control group (n=196) on or after March 5, 2019, and were included in analyses of HRQOL, pain, and time to first symptomatic skeletal event. The median age of patients was 71 years (IQR 65-75) in the [177 Lu]Lu-PSMA-617 group and 72·0 years (66-76) in the control group. Median time to first symptomatic skeletal event or death was 11·5 months (95% CI 10·3-13·2) in the [177 Lu]Lu-PSMA-617 group and 6·8 months (5·2-8·5) in the control group (hazard ratio [HR] 0·50, 95% CI 0·40-0·62). Time to worsening was delayed in the [177 Lu]Lu-PSMA-617 group versus the control group for FACT-P score (HR 0·54, 0·45-0·66) and subdomains, BPI-SF pain intensity score (0·52, 0·42-0·63), and EQ-5D-5L utility score (0·65, 0·54-0·78). Grade 3 or 4 haematological adverse events included decreased haemoglobin (80 [15%] of 529 assessable patients who received [177 Lu]Lu-PSMA-617 plus standard of care vs 13 [6%] of 205 who received standard of care only), lymphocyte concentrations (269 [51%] vs 39 [19%]), and platelet counts (49 [9%] vs five [2%]). Treatment-related adverse events leading to death occurred in five (1%) patients who received [177 Lu]Lu-PSMA-617 plus standard of care (pancytopenia [n=2], bone marrow failure [n=1], subdural haematoma [n=1], and intracranial haemorrhage [n=1]) and no patients who received standard of care only.Interpretation [177 Lu]Lu-PSMA-617 plus standard of care delayed time to worsening in HRQOL and time to skeletal events compared with standard of care alone. These findings support the use of [177 Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer who received previous androgen receptor pathway inhibitor and taxane treatment.Funding Advanced Accelerator Applications (Novartis).

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Findingown data
The time to improvement after worsening in BPI-SF pain intensity scale was shorter in the 177Lu-PSMA-617 arm than the control arm.
“The time to improvement after worsening in BPI-SF pain intensity scale was shorter in the 177Lu-PSMA-617 arm than the control arm (appendix p 8).”
Quote in the paperNot a substantial claim
Findingown data
Hazard ratios were in the range of 0.45 to 0.60 for all instruments.
“HRs were in the range of 0·45 to 0·60 for all instruments, and similar delays in time to worsening in score, clinical disease progression, or death were detected in prespecified and post hoc analyses.”
Quote in the paperSubstantial claim
Findingown data
The time to worsening in EQ-5D-5L utility score was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses.
“The time to worsening in EQ-5D-5L utility score was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses (figure 2C and table 1).”
Quote in the paperSubstantial claim
Findingown data
The predominant types of symptomatic skeletal event were radiation to relieve bone pain, followed by spinal cord compression.
“The predominant types of SSE were radiation to relieve bone pain, followed by spinal cord compression (table 2).”
Quote in the paperNot a substantial claim
Findingown data
Mean creatinine levels remained stable over time.
“Mean creatinine levels remained stable over time (figure 3C).”
Quote in the paperNot a substantial claim

Findingown data
Overall, 21/529 patients (4%) had 177Lu-PSMA-617 dose reductions owing to myelosuppression.
“Overall, 21/529 patients (4%) had 177Lu-PSMA-617 dose reductions owing to myelosuppression (appendix p 15).”
Quote in the paperNot a substantial claim
Findingown data
In the present analyses, time to symptomatic skeletal event or death was delayed in the 177Lu-PSMA-617 group compared versus control regardless of bone-targeted therapy use.
“In the present analyses, time to SSE or death was delayed in the 177Lu-PSMA-617 group compared versus control regardless of bone-targeted therapy use.”
Quote in the paperNot a substantial claim
Findingown data
The largest differences between the 177Lu-PSMA-617 and control groups were for FACT-P total score and the physical, emotional, and functional well-being subscales.
“The largest differences between the 177Lu-PSMA-617 and control groups were for FACT-P total score and the physical, emotional, and functional well-being subscales (table 1).”
Quote in the paperNot a substantial claim
Findingnone given
Low rates of haematologic and renal toxicity were observed with 177Lu-PSMA-617 treatment.
“Low rates of haematologic and renal toxicity were observed with 177Lu-PSMA-617 treatment.”
Quote in the paperSubstantial claim
Findingown data
Time to first symptomatic skeletal event or death was delayed in the subgroup without concurrent use of bone-targeted therapy (HR 0.50; 95% CI 0.37, 0.68).
“Time to first SSE or death was delayed in subgroups with (hazard ratio [HR], 0·49; 95% confidence interval [CI]: 0·36, 0·68) and without (HR, 0·50; 95% CI: 0·37, 0·68) concurrent use of bone-targeted therapy.”
- Also stated in: § Results · plain
  “Among the 310/581 (53%) patients not receiving bone-targeted therapy at baseline, the median time to first SSE or death was delayed in the 177Lu-PSMA-617 group compared with the control group (table 3 and appendix p 1).”
Quote in the paperNot a substantial claim
Findingown data
Haematologic abnormalities of CTCAE grade 3 or 4 were more frequent in the 177Lu-PSMA-617 group than in the control group, particularly for anemia, low lymphocyte levels, and low platelet counts.
“Haematologic abnormalities of CTCAE grade 3 or 4 were more frequent in the 177Lu-PSMA-617 group than in the control group, particularly for anemia, low lymphocyte levels, and low platelet counts (appendix p 12).”
Quote in the paperNot a substantial claim
Findingown data
Time to worsening in FACT-P total score was delayed in the 177Lu-PSMA-617 plus standard of care group versus standard of care alone (HR 0.46; 95% CI 0.35, 0.61).
“Time to worsening was delayed in the 177Lu-PSMA-617 plus SoC group (n = 385) versus SoC alone (n = 196) for FACT-P total score (HR, 0·46; 95% CI: 0·35, 0·61) and subdomains, BPI-SF pain intensity score (HR, 0·45; 95% CI: 0·33, 0·60) and EQ-5D-5L utility score (HR, 0·49; 95% CI: 0·40, 0·62).”
- Also stated in: § Results · plain
  “The time to worsening in FACT-P total score and all subscales was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses (figure 2A and table 1).”
Quote in the paperSubstantial claim
Findingown data
Time to first symptomatic skeletal event or death was delayed in the subgroup with concurrent use of bone-targeted therapy (HR 0.49; 95% CI 0.36, 0.68).
“Time to first SSE or death was delayed in subgroups with (hazard ratio [HR], 0·49; 95% confidence interval [CI]: 0·36, 0·68) and without (HR, 0·50; 95% CI: 0·37, 0·68) concurrent use of bone-targeted therapy.”
- Also stated in: § Results · plain
  “Among the 271/581 (47%) patients who were receiving bone-targeted therapy as part of SoC at baseline, the median time to first SSE or death was delayed in the 177Lu-PSMA-617 group compared with the control group (Table 3 and appendix p 1).”
Quote in the paperNot a substantial claim
Findingown data
The time to worsening in all BPI-SF scales was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses.
“The time to worsening in all BPI-SF scales was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses (figure 2B and table 1).”
Quote in the paperSubstantial claim
Findingnone given
Rates of haematologic and renal toxicity were low in patients receiving 177Lu-PSMA-617.
“Rates of haematologic and renal toxicity were low in patients receiving 177Lu-PSMA-617.”
- Also stated in: § Discussion · plain
  “Low rates of haematologic and renal toxicity were observed with 177Lu-PSMA-617 treatment.”
Quote in the paperSubstantial claim
Findingown data
Time to worsening in EQ-5D-5L utility score was delayed in the 177Lu-PSMA-617 plus standard of care group versus standard of care alone (HR 0.49; 95% CI 0.40, 0.62).
“Time to worsening was delayed in the 177Lu-PSMA-617 plus SoC group (n = 385) versus SoC alone (n = 196) for FACT-P total score (HR, 0·46; 95% CI: 0·35, 0·61) and subdomains, BPI-SF pain intensity score (HR, 0·45; 95% CI: 0·33, 0·60) and EQ-5D-5L utility score (HR, 0·49; 95% CI: 0·40, 0·62).”
- Also stated in: § Results · plain
  “The time to worsening in EQ-5D-5L utility score was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses (figure 2C and table 1).”
Quote in the paperSubstantial claim
Findingown data
Similar delays in time to worsening in score, clinical disease progression, or death were detected in prespecified and post hoc analyses.
“HRs were in the range of 0·45 to 0·60 for all instruments, and similar delays in time to worsening in score, clinical disease progression, or death were detected in prespecified and post hoc analyses.”
Quote in the paperNot a substantial claim
Findingown data
Symptomatic skeletal events occurred in 60/385 patients (16%) in the 177Lu-PSMA-617 group and 34/196 patients (17%) in the control group.
“SSEs occurred in 60/385 patients (16%) in the 177Lu-PSMA-617 group and 34/196 patients (17%) in the control group (table 2).”
Quote in the paperNot a substantial claim
Findingown data
Among patients receiving bone-targeted therapy as part of standard of care at baseline, the median time to first symptomatic skeletal event or death was delayed in the 177Lu-PSMA-617 group compared with the control group.
“Among the 271/581 (47%) patients who were receiving bone-targeted therapy as part of SoC at baseline, the median time to first SSE or death was delayed in the 177Lu-PSMA-617 group compared with the control group (Table 3 and appendix p 1).”
Quote in the paperNot a substantial claim
Findingown data
Results of post hoc analyses of time to worsening in BPI-SF scales using a single threshold of an increase of at least 2 points from baseline were similar to results using the prespecified threshold of an increase of at least 30% or at least 2 points from baseline.
“Results of post hoc analyses of time to worsening in BPI-SF scales using a single threshold of an increase of at least 2 points from baseline were similar to results of analyses using the prespecified threshold of an increase of least 30% or at least 2 points from baseline (appendix p 6).”
Quote in the paperNot a substantial claim
Findingown data
Among patients not receiving bone-targeted therapy at baseline, the median time to first symptomatic skeletal event or death was delayed in the 177Lu-PSMA-617 group compared with the control group.
“Among the 310/581 (53%) patients not receiving bone-targeted therapy at baseline, the median time to first SSE or death was delayed in the 177Lu-PSMA-617 group compared with the control group (table 3 and appendix p 1).”
Quote in the paperNot a substantial claim
Findingown data
Time to worsening in BPI-SF pain intensity score was delayed in the 177Lu-PSMA-617 plus standard of care group versus standard of care alone (HR 0.45; 95% CI 0.33, 0.60).
“Time to worsening was delayed in the 177Lu-PSMA-617 plus SoC group (n = 385) versus SoC alone (n = 196) for FACT-P total score (HR, 0·46; 95% CI: 0·35, 0·61) and subdomains, BPI-SF pain intensity score (HR, 0·45; 95% CI: 0·33, 0·60) and EQ-5D-5L utility score (HR, 0·49; 95% CI: 0·40, 0·62).”
- Also stated in: § Results · plain
  “The time to worsening in all BPI-SF scales was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses (figure 2B and table 1).”
Quote in the paperSubstantial claim
Findingown data
The time to worsening in FACT-P total score and all subscales was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses.
“The time to worsening in FACT-P total score and all subscales was delayed in the 177Lu-PSMA-617 group compared with the control group, in both prespecified and post hoc analyses (figure 2A and table 1).”
Quote in the paperSubstantial claim
Interpretationown data
Haematology and clinical chemistry results provide additional evidence for an acceptable haematological and renal safety profile.
“Haematology and clinical chemistry results provide additional evidence for an acceptable haematological and renal safety profile.”
Quote in the paperSubstantial claim
Premisecitation
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”
Quote in the paperSubstantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.
Study design and conductnone given
Patient-reported outcome questionnaires were completed during study treatment, but not after disease progression or discontinuation of study treatment in VISION.
“PRO questionnaires were completed during study treatment, but not after disease progression or discontinuation of study treatment in VISION.”
Quote in the paperSubstantial claim
Interpretationown data
These findings suggest that therapies that delay disease progression are associated with maintained health-related quality of life.
“These findings suggest that therapies that delay disease progression are associated with maintained HRQoL.”
Quote in the paperSubstantial claim
Study design and conductown data
Baseline characteristics were balanced between the groups.
“Baseline characteristics were balanced between the groups (appendix p 2).”
Quote in the paperSubstantial claim
Study design and conductown data
Among patients remaining in the study, patient-reported outcome completion rates were similar in the 177Lu-PSMA-617 group and the control group throughout study treatment.
“Among patients remaining in the study, PRO completion rates were similar in the 177Lu-PSMA-617 group and the control group throughout study treatment.”
Quote in the paperNot a substantial claim
Interpretationown data
In the VISION trial, addition of 177Lu-PSMA-617 to standard of care delayed the time to worsening of health-related quality of life and pain in patients with metastatic castration-resistant prostate cancer previously treated with at least one androgen receptor pathway inhibitor and one or two taxanes.
“In the VISION trial, addition of 177Lu-PSMA-617 to SoC delayed the time to worsening of HRQoL and pain in patients with mCRPC previously treated with at least one ARPI and one or two taxanes.”
Quote in the paperSubstantial claim
- Rests on an assumption: The VISION population was heavily pre-treated with short remaining life expectancy, so deterioration in health-related quality of life and pain was likely to manifest within the follow-up time.
Premisecitation
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”
Quote in the paperSubstantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.
Study design and conductcitation
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”
Quote in the paperNot a substantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.
Study design and conductnone given
The study drop-out rate was higher in the control group than the 177Lu-PSMA-617 group.
“However, the study drop-out rate was higher in the control group than the 177Lu-PSMA-617 group.”
Quote in the paperNot a substantial claim
Interpretationreasoning
These additional findings from VISION strengthen the rationale for adoption of 177Lu-PSMA-617 as a treatment option in patients with metastatic castration-resistant prostate cancer who have received previous androgen receptor pathway inhibitor and taxane treatment.
“These additional findings from VISION strengthen the rationale for adoption of 177Lu-PSMA-617 as a treatment option in patients with mCRPC who have received previous ARPI and taxane treatment.”
Quote in the paperSubstantial claim
Interpretationown data
In summary, the efficacy of 177Lu-PSMA-617 plus standard of care in delaying radiographic progression-free survival and prolonging overall survival in patients with metastatic castration-resistant prostate cancer was associated with a longer period without deterioration in patient-reported health-related quality of life and pain, compared with standard of care alone.
“In summary, the efficacy of 177Lu-PSMA-617 plus SoC in delaying rPFS and prolonging OS in patients with mCRPC was associated with a longer period without deterioration in patient-reported HRQoL and pain, compared with SoC alone.”
Quote in the paperSubstantial claim
- The authors state this as an assumption: Patients who did not complete questionnaires because they died or experienced disease progression were assumed to have worsened in health-related quality of life and pain.

May combine two claims. 14
Classified as probably not a substantial claim. 11

May combine two claims.
Findingown data
The incidence of creatinine abnormalities of CTCAE grade 3 or above was low, and similar between the 177Lu-PSMA-617 group and the control group.
“The incidence of creatinine abnormalities of CTCAE grade 3 or above was low, and similar between the 177Lu-PSMA-617 group and the control group (appendix p 12).”
Quote in the paperNot a substantial claim
May combine two claims.
Findingown data
Worsening was delayed across all patient-reported outcomes, and all subscales and domains, with the greatest difference in median time to event in BPI-SF pain intensity and FACT-P total score.
“Worsening was delayed across all PROs, and all subscales and domains, with the greatest difference in median time to event in BPI-SF pain intensity and FACT-P total score.”
Quote in the paperSubstantial claim
May combine two claims.
Findingown data
Time to health-related quality-of-life worsening was delayed with 177Lu-PSMA-617 on both the FACT-P and EQ-5D-5L, with similar hazard ratios.
“Time to HRQoL worsening was delayed with 177Lu-PSMA-617 on both the FACT-P and EQ-5D-5L, with similar HRs.”
Quote in the paperSubstantial claim
May combine two claims.
Findingown data
The time to worsening in EQ-5D-5L utility score of 0.10 points was also delayed in the 177Lu-PSMA-617 group compared with the control group, both when clinical disease progression or death were included and when not included.
“The time to worsening in EQ-5D-5L utility score of 0·10 points was also delayed in the 177Lu-PSMA-617 group compared with the control group, both when clinical disease progression or death were included in the definition and when not included (appendix p 9).”
Quote in the paperSubstantial claim
May combine two claims.
Findingcitation
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”
Quote in the paperNot a substantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown data
Mean haemoglobin levels and platelet counts remained stable over time.
“Mean haemoglobin levels and platelet counts remained stable over time (figure 3A–B).”
Quote in the paperNot a substantial claim
May combine two claims.
Findingcitation
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.”
Quote in the paperNot a substantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.
May combine two claims.
Study design and conductown data
Questionnaire completion rates were similar at the end-of-treatment visit, with data available for approximately 45% of patients in both groups.
“Questionnaire completion rates were similar at the end-of-treatment visit, with data available for approximately 45% of patients in both groups (appendix p 3).”
Quote in the paperNot a substantial claim
May combine two claims.
Interpretationown data
This safety profile supports 177Lu-PSMA-617 use in often elderly patients with late-stage disease and potentially in younger patients with earlier-stage disease.
“This safety profile supports 177Lu-PSMA-617 use in often elderly patients with late-stage disease29 and potentially in younger patients with earlier-stage disease.”
Quote in the paperSubstantial claim0 of 1 sources checked
- cites [29] Gillessen, 2021, Decreased fracture rate by mandating bone protecting agents in the EORTC 1333/PEACEIII trial combining Ra223 with enzalutamide versus enzalutamide alone: an updated safety analysis, Proc Am Soc Clin Oncol
  Not checked in the free run.
May combine two claims.
Interpretationown data
The radioligand 177Lu-PSMA-617 improves quality of life and delays symptomatic skeletal events in patients with advanced metastatic castration-resistant prostate cancer.
“The radioligand 177Lu-PSMA-617 improves quality of life and delays SSEs in patients with advanced mCRPC.”
Quote in the paperSubstantial claim
Classified as probably not a substantial claim.
Study design and conductown data
Patients were randomised 2:1 using an interactive response system to receive 177Lu-PSMA-617 plus protocol-permitted standard of care or protocol-permitted standard of care alone using a permuted block scheme.
“In this open-label study, patients were randomised 2:1 using an interactive response system to receive either 177Lu-PSMA-617 plus protocol-permitted SoC (177Lu-PSMA-617 group) or protocol-permitted SoC alone (control group) using a permuted block scheme.”
Quote in the paperSubstantial claim
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown data
Among patients remaining on study treatment, questionnaire completion rates were high.
“Among patients remaining on study treatment, questionnaire completion rates were high (appendix p 3).”
Quote in the paperNot a substantial claim
May combine two claims.
Interpretationown data
The results support the conclusion that there was no adverse effect of 177Lu-PSMA-617 on health-related quality of life or pain, despite the limitation that data were collected only during study treatment.
“The results support the conclusion that there was no adverse effect of 177Lu-PSMA-617 on HRQoL or pain, despite the limitation that data were collected only during study treatment.”
Quote in the paperSubstantial claim
- The authors state this as an assumption: Patients who did not complete questionnaires because they died or experienced disease progression were assumed to have worsened in health-related quality of life and pain.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone given
Safety was analysed according to treatment received in the safety analysis set, comprising all patients who received at least one dose of randomised treatment.
“Safety was analysed according to treatment received in the safety analysis set, comprising all patients who received at least one dose of randomised treatment.”
Quote in the paperNot a substantial claim
Classified as probably not a substantial claim. May combine two claims.
Study design and conductown data
PSMA-positive tumor status was determined by 68Ga-PSMA-11 PET-CT imaging during screening and evaluated by independent central review.
“PSMA-positive tumor status was determined by gallium (68Ga) gozetotide (also known as [68Ga]Ga-PSMA-11; 68Ga-PSMA-11) positron emission tomography (PET)-CT imaging during screening and evaluated by independent central review.”
Quote in the paperSubstantial claim
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitation
The lack of double-blinding and placebo control are limitations shared by studies of other radiopharmaceuticals.
“The lack of double-blinding and placebo control are limitations shared by studies of other radiopharmaceuticals.30”
Quote in the paperNot a substantial claim0 of 1 sources checked
- cites [30] Saad, 2015, Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302, Eur Urol source
  Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown data
Randomisation was stratified by baseline lactate dehydrogenase level, presence of liver metastases, ECOG performance status, and inclusion of androgen receptor pathway inhibitor in protocol-permitted standard of care.
“Randomisation was stratified by baseline lactate dehydrogenase level (≤260 IU/L or >260 IU/L), presence of liver metastases (yes or no), ECOG performance status (0/1 or 2), and inclusion of ARPI in protocol-permitted SoC (yes or no).”
Quote in the paperNot a substantial claim
May combine two claims.
Premisecitation
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).”
- Also stated in: § Introduction · plain
 “In the alternate primary endpoints of the phase 3 VISION trial, 177Lu-PSMA-617 prolonged radiographic progression-free survival (rPFS; hazard ratio [HR], 0·40; 99·2% confidence interval [CI]: 0·29, 0·57; p<0·001) and overall survival (OS, 0·62; 95% CI: 0·52, 0·74; p<0·001) when added to protocol-permitted standard of care (SoC) in patients with advanced PSMA-positive mCRPC.12”
Quote in the paperSubstantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
 Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductnone given
Outcomes were analysed in intention-to-treat populations.
“Outcomes were analysed in intention-to-treat populations.”
- Also stated in: § Statistical analysis · plain
  “Efficacy outcomes were analysed in intention-to-treat populations; HRQoL outcomes were analysed in the intention-to-treat subset randomised on or after March 5, 2019.”
Quote in the paperSubstantial claim
Classified as probably not a substantial claim.
Interpretationcitation
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”
Quote in the paperSubstantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone given
Radiographic imaging was evaluated in accordance with Response Evaluation Criteria in Solid Tumors 1.1 and Prostate Cancer Working Group 3 criteria.
“Radiographic imaging was evaluated in accordance with Response Evaluation Criteria in Solid Tumors 1·1 (RECIST 1·1) and Prostate Cancer Working Group 3 (PCWG3) criteria.”
Quote in the paperNot a substantial claim
May combine two claims.
Study design and conductcitation
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”
Quote in the paperSubstantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitation
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).”
Quote in the paperNot a substantial claim0 of 1 sources checked
- cites [12] Sartor, 2021, Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer, N Engl J Med source
  Not checked in the free run.

23 of 23

The authors state this as an assumption.
Patients who did not complete questionnaires because they died or experienced disease progression were assumed to have worsened in health-related quality of life and pain.
“Death and disease progression were included in the prespecified composite endpoints of HRQoL and pain worsening, which were therefore assumed to have worsened in patients who did not complete questionnaires because they died or experienced disease progression.”
The paper relies on this without support.
The VISION population was heavily pre-treated with short remaining life expectancy, so deterioration in health-related quality of life and pain was likely to manifest within the follow-up time.
“The VISION population was heavily pre-treated with short remaining life expectancy, so deterioration in HRQoL and pain was likely to manifest within the follow-up time.”
The paper relies on this without support.
Patients with advanced and highly pre-treated metastatic castration-resistant prostate cancer inevitably experience declining health-related quality of life and death.
“Sustained worsening was not assessed in VISION because of the relatively long interval between PRO assessments (6 or 12 weeks), and because of inevitable declining HRQoL and death in patients with advanced and highly pre-treated mCRPC.”

3 of 3

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?

177Lu-PSMA-617 improved health-related quality of life and pain outcomes compared with standard of care.
“Subsequent studies have further evaluated health-related quality of life and pain outcomes using 177Lu-PSMA- 617 and found that these metrics were both improved as compared to treatment with SOC”
From PSMA-based Therapies and Novel Therapies in Advanced Prostate Cancer: The Now and the Future (2025) · cites this paper as [12]

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

LDH stratification cutoff uses conflicting units
Minor
The randomisation section gives the lactate dehydrogenase cutoff in IU/L, while the statistical analysis section gives the same numeric cutoff in U/mL. Those units differ by a factor of 1000.

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Bone-related parameters are the main prognostic factors for overall survival in men with bone metastases from castration-resistant prostate cancer
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Self-citation

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1 of the 34 references couldn’t be matched to a known paper.

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177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial
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
Self-citation
Overall survival with [177Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer (TheraP): secondary outcomes of a randomised, open-label, phase 2 trial
Hofman, 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
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Final overall survival and safety analyses of the phase III PSMAfore trial of [177Lu]Lu-PSMA-617 versus change of androgen receptor pathway inhibitor in taxane-naive patients with metastatic castration-resistant prostate cancer
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Multivariable models of outcomes with [177Lu]Lu-PSMA-617: analysis of the phase 3 VISION trial
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Current clinical application of lutetium‑177 in solid tumors (Review)
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PSMA Radiotheranostics in Prostate Cancer: Principles, Practice, and Future Prospects
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Combination prostate-specific membrane antigen-targeted radiopharmaceutical therapy in metastatic prostate cancer
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Radioactivity levels in the saliva of patients undergoing targeted radioligand therapy with [177Lu]Lu-PSMA-I&T and [177Lu]Lu-DOTA-TOC
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177Lu-PSMA for prostate cancer: progress, challenges and future perspectives
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Review of radiopharmaceutical therapy in prostate cancer
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PROQURE-I: a phase I study adding concurrent [177Lu]Lu-PSMA-617 to EBRT and ADT in curative intent treatment of N1 prostate cancer
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Outcome-driven dosimetry optimization for [177Lu]Lu-PSMA-617 radiopharmaceutical therapy: proof of concept on single time point dosimetry optimization
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Why does PSMA PET improve quality of life?
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PSMA-Directed Radioligand Therapy for Metastatic Prostate Cancer
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Case of the month from the Radiotherapy Unit, Department of Medical and Surgical Sciences, University of Bologna, Italy: breaking boundaries beyond five lesions with multifocal stereotactic radiotherapy in prostate cancer
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Optimizing assessments of quality of life in contemporary prostate cancer clinical trials
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Genomic Discoveries: Precision Medicine and Personalized Approaches in Prostate Cancer Care
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Recommendations from the Galician Oncological Society and the Galician Society of Nuclear Medicine for the use of 177Lu-PSMA-617 radioligand-therapy in prostate cancer
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Neue Therapieoptionen des kastrationsresistenten Prostatakarzinoms
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Systemic treatment options for metastatic castration resistant prostate cancer: A living systematic reviewPreprint
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Handlungsempfehlungen und Maßnahmen
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Krieger, J., Berkemeier, F., & Sussmann, S. (2025) · Medizinisch Wissenschaftliche Verlagsgesellschaft eBooks · doi:10.32745/9783954669851-2
Anhang
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Weißbuch Radioligandentherapie in Deutschland: Eine Bedarfsanalyse und Handlungsempfehlungen für die Nuklearmedizin
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Tolerability of PSMA radioligand therapy in metastatic prostate cancer patients with baseline mild to moderate leukopenia
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Trf-34-86j8wpmn1e8y2q Promotes Occurrence and Development of Gastric Cancer Via Combining with LratPreprint
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PSMA-Radioligandentherapie – State of the Art
Berliner, C., Grünwald, V., Krafft, U., Himmen, S., & Fendler, W. P. (2025) · Die Urologie · doi:10.1007/s00120-025-02661-y · Cited by 1 · see citing works
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Predicting hematologic toxicity of lutetium-177 prostate-specific membrane antigen therapy in metastatic castration-resistant prostate cancer using pretreatment gallium-68 prostate-specific membrane antigen positron emission tomography imaging: preliminary data in Asian patients
Huang, Y.-Y., Huang, K., & Lee, P. (2025) · Nuclear Medicine Communications · doi:10.1097/mnm.0000000000002086
Additional file 2 of Polymer composite microspheres loading 177Lu radionuclide for interventional radioembolization therapy and real-time SPECT imaging of hepatic cancer
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Additional file 1 of Polymer composite microspheres loading 177Lu radionuclide for interventional radioembolization therapy and real-time SPECT imaging of hepatic cancer
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Health-related quality of life, pain, and symptomatic skeletal events with [177Lu]Lu-PSMA-617 in patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): an open-label, randomised, phase 3 trial
Fizazi, K. S., Morris, M. J., Shore, N. D., Chi, K. N., Crosby, M. J., Bono, J. S. D., Herrmann, K., Roubaud, G., Nagarajah, J., Fleming, M. T., et al. (2025) · The Lancet Oncology · doi:10.1016/s1470-2045(25)00189-5 · Cited by 22 · see citing works
Self-citation
576MO Health-related quality of life (HRQoL), pain and safety outcomes in the phase III VISION study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer
Fizazi, K. S., Herrmann, K., Krause, B. J., Rahbar, K., Chi, K. N., Morris, M. J., Sartor, O. A., Tagawa, S. T., Kendi, A. T., Vogelzang, N. J., et al. (2021) · Annals of Oncology · doi:10.1016/j.annonc.2021.08.1089 · Cited by 7 · see citing works
Self-citation
Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION).
Morris, M. J., Bono, J. S. D., Chi, K. N., Fizazi, K. S., Herrmann, K., Rahbar, K., Tagawa, S. T., Nordquist, L. T., Vaishampayan, N., El-Haddad, G. E., et al. (2021) · Journal of Clinical Oncology · doi:10.1200/jco.2021.39.15_suppl.lba4 · Cited by 78 · see citing works
Self-citation
Health-related quality of life and pain in a phase 3 study of [177Lu]Lu-PSMA-617 in taxane-naïve patients with metastatic castration-resistant prostate cancer (PSMAfore).
Fizazi, K. S., Morris, M. J., Shore, N. D., Chi, K. N., Crosby, M. J., Bono, J. S. D., Herrmann, K., Roubaud, G., Nagarajah, J., Fleming, M. T., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.2024.42.16_suppl.5003 · Cited by 5 · see citing works
Self-citation
Efficacy, safety, and quality of life outcomes of [177Lu] Lu-PSMA radioligand therapy in metastatic castration-resistant prostate cancer: a GRADE-assessed systematic review, meta-analysis and trial sequential analysis
Mubarika, M., Maaz, M., Muhammad, A., Emmama, S., Mazhar, Z., Khalid, M., kumari, J., Alamin, M. H., Ayalew, B. D., Noor, H., et al. (2026) · International Urology and Nephrology · doi:10.1007/s11255-026-05329-4 · Cited by 1 · see citing works

Authors: 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., Calais, J., Nagarajah, J., Wei, X. X., Koshkin, V. S., Beauregard, J.-M., Chang, B., Ghouse, R., DeSilvio, M., Messmann, R. A., & de Bono, J.
Affiliations: Université Paris-Saclay (FR)
Essen University Hospital (DE)
Universitätsmedizin Rostock (DE)
University Hospital Münster (DE)
BC Cancer Agency (CA)
Memorial Sloan Kettering Cancer Center (US)
Tulane University (US)
Weill Cornell Medicine (US)
Mayo Clinic (US)
Comprehensive Cancer Centers of Nevada (US)
Radboud University Medical Center (NL)
Dana-Farber Cancer Institute (US)
University of California, San Francisco (US)
CHU de Québec-Université Laval (CA)
Radiation Oncology Associates (US)
Novartis (Switzerland) (CH)
Novartis (United States) (US)
Corresponding author: Fizazi, Karim
ORCID: Fizazi, Karim
Krause, Bernd J
Rahbar, Kambiz
Chi, Kim N
Morris, Michael J
Sartor, Oliver
Tagawa, Scott T
Kendi, Ayse T
Vogelzang, Nicholas
Nagarajah, James
Wei, Xiao X
Koshkin, Vadim S
Beauregard, Jean-Mathieu
Messmann, Richard A
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2023-06
Volume: 24
Issue: 6
Pages: 597-610
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(23)00158-4
PMC: PMC10641914
OpenAlex: W4378800385
Cited by: 125
References: 34
Citations by year: 2026: 32 · 2025: 43 · 2024: 41 · 2023: 9
FWCI: 23.03
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (am, 182 d)
doi.org/10.15223/policy-017 (stm-asf)
doi.org/10.15223/policy-037 (stm-asf)
doi.org/10.15223/policy-012 (stm-asf)
doi.org/10.15223/policy-029 (stm-asf)
doi.org/10.15223/policy-004 (stm-asf)
Locations: The Lancet Oncology (acceptedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
eScholarship (California Digital Library) (submittedVersion)
Radboud Repository (Radboud University) (submittedVersion)
Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
Funders: Novartis
Advanced Accelerator Applications SA
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
Keywords: 177Lu-PSMA-617, PSMA radioligand therapy, metastatic castration-resistant prostate cancer, health-related quality of life, pain, FACT-P, EQ-5D-5L, Brief Pain Inventory, treatment-related adverse events
MeSH terms: Aged, Antineoplastic Combined Chemotherapy Protocols, Bridged-Ring Compounds, Dipeptides, Heterocyclic Compounds, 1-Ring, Humans, Male, Pain, Quality of Life, Receptors, Androgen, Prostate-Specific Antigen, Taxoids, Androgen Receptor Antagonists, Standard of Care, Prostatic Neoplasms, Castration-Resistant

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Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

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