European urology oncology · 2025
Stage Migration on Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography in Comparison to Conventional Imaging in Patients with High-risk Prostate Cancer Referred for Radiation Therapy: Results from the Phase 2/3 THUNDER Trial.
Клиническое исследование II фазыКлиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Kleiburg Fleur, Dirix Piet, Fonteyne Valérie, Bral Samuel, De Troyer Bart, Sautois Brieuc, Lamande Maréva, Liefhooghe Nick, Grisay Guillaume, Meersschout Sabine, Vandermeulen Ad, Jullian Nicolas, Staelens Lorenzo, Poelaert Filip, Strijbos Michiel, Verschueren Jolien, Goffin Karolien, Withofs Nadia, Ost Piet
Аннотация
BACKGROUND AND OBJECTIVE: In high-risk prostate cancer, the proPSMA trial showed upstaging with prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) in 14% of patients. We hypothesised that the probability of stage migration in a patient population referred for curative-intent radiotherapy would be higher. Here we report stage migration results according to PSMA PET/CT in the first year of inclusion in the phase 2/3 THUNDER trial (NCT06282588).
METHODS: Patients with high-risk prostate cancer screened between December 2023 and December 2024 in the THUNDER trial with both conventional imaging (CT, bone scintigraphy) and PSMA PET/CT within 16 weeks before screening were included (n = 142). Stage migration according to the TNM classification versus the molecular imaging (miTNM) classification (PROMISE v2 criteria) was assessed using descriptive statistics.
KEY FINDINGS AND LIMITATIONS: PSMA PET/CT led to stage migration in 43 patients, of whom 42 (30%) were upstaged and one (1%) was downstaged. Upstaging to miN1-2 disease occurred in 32 patients (23%), and to miM1a-c disease in 19 patients (13%). The probability of upstaging increased with the number of high-risk features. In the subgroup meeting the STAMPEDE M0 high-risk criteria (n = 73), PSMA PET/CT upstaged 27 patients (37%), including upstaging to miM1a-c disease in 14 (19%). Limitations include the absence of central review of the imaging procedures.
CONCLUSIONS AND CLINICAL IMPLICATIONS: One-third of patients with high-risk prostate cancer referred for curative-intent radiotherapy were upstaged on PSMA PET/CT. This finding supports the use of PSMA PET/CT for staging, especially in patients with multiple high-risk features, and suggests a need for treatment adaptations accordingly, which will be further investigated in the THUNDER trial.
METHODS: Patients with high-risk prostate cancer screened between December 2023 and December 2024 in the THUNDER trial with both conventional imaging (CT, bone scintigraphy) and PSMA PET/CT within 16 weeks before screening were included (n = 142). Stage migration according to the TNM classification versus the molecular imaging (miTNM) classification (PROMISE v2 criteria) was assessed using descriptive statistics.
KEY FINDINGS AND LIMITATIONS: PSMA PET/CT led to stage migration in 43 patients, of whom 42 (30%) were upstaged and one (1%) was downstaged. Upstaging to miN1-2 disease occurred in 32 patients (23%), and to miM1a-c disease in 19 patients (13%). The probability of upstaging increased with the number of high-risk features. In the subgroup meeting the STAMPEDE M0 high-risk criteria (n = 73), PSMA PET/CT upstaged 27 patients (37%), including upstaging to miM1a-c disease in 14 (19%). Limitations include the absence of central review of the imaging procedures.
CONCLUSIONS AND CLINICAL IMPLICATIONS: One-third of patients with high-risk prostate cancer referred for curative-intent radiotherapy were upstaged on PSMA PET/CT. This finding supports the use of PSMA PET/CT for staging, especially in patients with multiple high-risk features, and suggests a need for treatment adaptations accordingly, which will be further investigated in the THUNDER trial.