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The 23rd Annual Meeting of the American Urological Oncology Society (SUO) in 2022 was held
in San Diego, USA from November 30 to December 2, local time.
As an internationally influential urological oncology conference, the 2022 SUO Annual Meeting has announced the conference schedule
recently.
Many internationally renowned urological oncology experts, doctors and scientists gathered together to focus on the cutting-edge progress in the field of conversion therapy for prostate, kidney and bladder cancer, bringing us a wonderful academic feast
.
In recent years, the development of 18F-labeled prostate-specific membrane antigen (PSMA) positron emission tomography (PET) has been remarkable, and it is reported that this year the FDA has accepted the new drug application (NDA)
of 18F-labeled new PSMA-targeted PET imaging agent (18F-rhPSMA-7.
3).
This year's SUO conference announced the progress of a phase III study of 18F-rhPSMA-7.
3, which is compiled as follows
.
3 PET Diagnostic Performance and Safety in Newly Diagnosed Prostate Cancer Patients: Phase 3 Prospective Multicenter Study Results (LIGHTHOUSE)
First author by Brian F.
Chapin
Summary number: Poster #134
：Diagnostic Performance And Safety Of 18F-rhPSMA-7.
3 PET In Patients With Newly Diagnosed Prostate Cancer: Results From a Phase 3, Prospective, Multicenter Study (LIGHTHOUSE)
Research background
PSMA-PET has become the main means
of imaging prostate cancer.
18F-rhPSMA-7.
3 is a novel high-affinity PSMA ligand
.
This study is the first to report the diagnostic performance and safety of
18F-rhPSMA-7.
3 in the Phase 3 LIGHTHOUSE study (NCT04186819) in newly diagnosed prostate cancer patients scheduled for radical prostatectomy (RP).
Research methods
The efficacy analysis population (EAP) of the LIGHTHOUSE study included all patients who received 18F-rhPSMA-7.
3-PET followed by RP and pelvic lymph node (PLN) dissection, and the primary endpoints were the sensitivity and specificity of 18F-rhPSMA-7.
3-PET for detection of PLN metastasis based on histopathological criteria, with preset statistical thresholds of 95% confidence intervals of 22.
5% and 82.
5%, respectively
。 Further subgroup analyses
were performed in patients stratified by prostate cancer risk category.
PET/CT for unfavorable intermediate- to high-risk prostate cancer patients who choose to receive RP treatment with regional PLN dissection 50-70 min after intravenous injection of 296 MBq (8mCi) 18F-rhPSMA-7.
3 with safety follow-up within 5 days and planned surgery
within 60 days.
The imaging results were interpreted by local readers prior to the patient's RP and then submitted to the three central readers for blind evaluation
.
EAP included 296 patients, including 121 (41%) in T1 stage, 112 (38%) in T2 stage, 45 (15%) in T3 stage, with a median last PSA of 8.
45 (range: 1.
15-120 ng/mL), and 197 (67%) were very high/high-risk patients
.
Based on blinded evaluation of 3 readers, 23 to 37 (7.
7%-13%) patients in EAP had PLN
positive for 18F-rhPSMA-7.
3.
Extrapelvic lesions were detected in all patients (n=352) receiving 18F-rhPSMA-7.
3-PET, and 56 to 98 (16% to 28%) patients were assessed as having extrapelvic lesions
.
The sensitivity of Reader 1, 2 and 3 for PLN detection (EAP) was 30% (95% CI, 19.
6-42.
1), 27% (95% CI, 17.
2-39.
1) and 23% (95% CI, 13.
7-34.
4), respectively, without reaching the preset statistical thresholds; The specificities were 93% (95% CI, 88.
8-95.
9), 94% (95% CI, 89.
8-96.
6), and 97% (95% CI, 93.
7-98.
7), respectively, and all met and exceeded the preset thresholds
.
Table 1: Sensitivity and specificity for stratification by risk category
Table 1 shows the sensitivity and specificity
of stratification by risk category.
In high- and very high-risk stratification, specificity was high for all readers (≥93%), but sensitivity of 18F-rhPSMA-7.
3-PET was higher in very high-risk patients than in intermediate-risk patients
.
No serious adverse events were
observed.
These data support that 18F-rHPSMA-7.
3-PET/CT provides clinically beneficial information to identify clinical N1 disease prior to surgery, particularly in patients
with high-risk or very high-risk prostate cancer.
The trend towards reduced sensitivity observed in this population is consistent with previously reported sensitivity for radiopharmaceutical classes targeted by PSMA and balanced
by high specificity.
In summary, 18F-rhPSMA-7.
3 was well tolerated in patients and showed a good benefit/risk ratio
in newly diagnosed prostate cancer patients who were scheduled for RP and PLN resection.
The cover image and accompanying pictures are from: SUO conference official
Reference source:
https://suonet.
org/meetings/upcoming-meetings/program-schedule.
aspx
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