Prostate cancer: VISION trial

Abbreviations

No EU-CTR

  • VISION references
    2021-09-16
    O. Sartor
    Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer
Investigated (inv)
Comparator (comp)

Lu-PSMA-617

SoC

551

280

Phase:

3

Randomisation:

Open label

Primary tumour:

Prostate

Subtype (biomarker):

mCRPC

Stage:

meta

Line of therapy:

L3

Primary
Lu-PSMA-617
SoC
HR
p
rPFS
8.7 mo
3.4 mo
0.40 (0.29-0.57)
<0.001
OS ITT
15.3 mo
11.3 mo
0.62 (0.52-0.74)
<0.001
Secondaries
Lu-PSMA-617
SoC
HR
p
TFSE
11.5 mo
6.8 mo
0.50 (0.40-0.62)
<0.001
ORR
29.8%
1.7%
24.99 (6.05-103.24)
<0.001
≥ 50% PSA decreases
46.0%
7.1%
11.19 (6.25-20.04)
na
≥ 80% PSA decreases
33.0%
2.0%
23.62 (8.57-65.11)
na
(all grades, %)
Lu-PSMA-617
SoC
p
Fatigue
43.1
22.9
NA
Dry mouth
38.8
0.5
NA
Nausea
35.3
16.6
NA
Anemia (grade ≥3)
12.9
4.9
NA
Thrombocytopenia
17.2
4.4
NA
Lymphopenia
14.2
3.9
NA
AE that led to reduction in Lu-PSMA
5.7
AE that led to interruption of Lu-PSMA
16.1
AE that led to discontinuation of Lu-PSMA
11.9
AE that led to death
3.6
2.9
NA
  • Inclusion
  • Exclusion

- Patients must have the ability to understand and sign an approved informed consent form (ICF).dc-return- Patients must have the ability to understand and comply with all protocol requirements.dc-return- Patients must be ≥18 years of age.dc-return- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.dc-return- Patients must have a life expectancy >6 months.dc-return- Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.dc-return- Patients must be 68Ga-PSMA-11 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive, and eligible as determined by the sponsor's central reader.dc-return- Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).dc-return- Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone).dc-return- Patients must have been previously treated with at least 1, but no more

- Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.dc-return- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of randomization.dc-return- Any investigational agents within 28 days prior to day of randomization.dc-return- Known hypersensitivity to the components of the study therapy or its analogs.dc-return- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.dc-return- Transfusion for the sole purpose of making a subject eligible for study inclusion.dc-return- Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma

Characteristics
Lu-PSMA-617
SoC
Age
Median age (range)dc-comma yr
71.0 (52–94)
72.0 (51–89)
ECOG
0 or 1
91.4%
91.3%
Site of disease
Lung
9.1%
10.2%
Liver
12.2%
13.3%
Lymph node
50.1%
50.5%
Bone
91.2%
91.3%
PSA level
Median PSA level (range) — ng/ml
93.2 (0–6988)
90.7 (0–6600)
Alkaline phosphatase level
Median alkaline phosphatase level (range) — IU/liter
108.0 (26–2524)
96.0 (34–1355)
LDH level
Median LDH (range) — IU/liter
230.5 (119–5387)
232.0 (105–2693)
Gleason score at diagnosis
8 - 10
58.7%
60.2%
Unknown
7.3%
9.7%
Prostatectomy
Previous prostatectomy
41.3%
41.8%
Previous androgen-receptor–pathw
One regimen
55.3%
50.0%
Two regimens
39.0%
43.9%
More than two regimens
5.7%
6.1%
Previous taxane therapy
One regimen
53.8%
52.0%
Two regimens
44.9%
46.9%
Docetaxel
97.9%
97.4%
Cabazitaxel
41.8%
42.9%
Ad-hoc:
no.pts inv.
no.pts comp.
Lu-PSMA-617
SoC
HR
p
rPFS ITT
551
280
8.8 mo
3.6 mo
0.43 (0.32-0.58)
na
OS
240
129
14.6 mo
10.4 mo
0.63 (0.51-0.79)
na
  • rPFS
  • OS ITT
analisys of rPFS
Lu-PSMA-617
SoC
HR (95% CI)
Use of androgen receptor pathway inhibitors
Yes
0.53 (0.37-0.76)
No
0.27 (0.19-0.39)
LDH
≤260 IU/L
0.44 (0.32-0.61)
>260 IU/L
0.37 (0.25-0.53)
Liver metastases
Yes
0.28 (0.15-0.53)
No
0.43 (0.33-0.57)
ECOG score
0 or 1
0.43 (0.33-0.56)
2
0.18 (0.08-0.38)
Age
<65 yr
0.42 (0.23-0.76)
≥65 yr
0.40 (0.30-0.53)
Race
White
0.38 (0.29-0.50)
African Maerican or Black
0.72 (0.23-2.20)
analisys of OS ITT
Lu-PSMA-617
SoC
HR (95% CI)
Use of androgen receptor pathway inhibitors
Yes
0.54 (0.41-0.70)
No
0.68 (0.53-0.87)
LDH
≤260 IU/L
0.63 (0.50-0.80)
>260 IU/L
0.63 (0.48-0.84)
Liver metastases
Yes
0.87 (0.53-1.43)
No
0.62 (0.51-0.76)
ECOG score
0 or 1
0.61 (0.50-0.74)
2
0.63 (0.35-1.13)
Age
<65 yr
0.73 (0.49-1.10)
≥65 yr
0.59 (0.48-0.73)
Race
White
0.63 (0.52-0.77)
African America or Black
0.60 (0.29-1.24)