BJU international · 2025
Feasibility of randomisation to radical prostatectomy or standard care in patients with metastatic prostate cancer.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Van den Eynde Lies, Ost Piet, Verla Wesley, Everaerts Wouter, Fransis Karen, Uvin Pieter, Ameye Filip, Van Erps Thomas, Fonteyne Valérie, Van Praet Charles, Lumen Nicolaas
Аннотация
OBJECTIVE: To evaluate the feasibility of randomising patients with newly diagnosed metastatic prostate cancer (mPCa) to cytoreductive radical prostatectomy (cRP) plus systemic standard of care (SOC) vs SOC alone in Belgian centres.
PATIENTS AND METHODS: This is a phase II, multicentre, prospective, randomised, open-label feasibility trial. Patients with newly diagnosed mPCa were screened across six centres from August 2018 to August 2024. The aim was to randomise 86 patients to either cRP with pelvic lymphadenectomy plus systemic SOC or SOC alone (including radiotherapy in low-volume disease). Eligible patients had an Eastern Cooperative Oncology Group Performance Status of 0-1 and were considered suitable candidates for local treatment. The primary endpoint was the feasibility of randomisation, assessed by the randomisation rate (randomised/eligible).
RESULTS: A total of 325 patients with newly diagnosed mPCa were screened, of whom 170 (52%) were eligible. The main reasons for ineligibility included unresectable tumours (42% [65/155]) and inadequate surgical fitness (37% [58/155]). Among eligible patients, 75% were excluded (127/170), mostly due to patient refusal (68% [86/127]) and inclusion in competing studies (21% [27/127]). A total of 43 patients were randomised: 21 to cRP and 22 to SOC, yielding a randomisation rate of 25% (43/170). Randomisation rates were lower than anticipated, limiting feasibility in the present trial setting.
CONCLUSION: Randomising men with newly diagnosed mPCa to RP plus SOC vs SOC alone proved challenging in this Belgian trial. Major barriers to recruitment included limited surgical eligibility and patient refusal. Targeted recruitment strategies or alternative trial designs should be considered.
PATIENTS AND METHODS: This is a phase II, multicentre, prospective, randomised, open-label feasibility trial. Patients with newly diagnosed mPCa were screened across six centres from August 2018 to August 2024. The aim was to randomise 86 patients to either cRP with pelvic lymphadenectomy plus systemic SOC or SOC alone (including radiotherapy in low-volume disease). Eligible patients had an Eastern Cooperative Oncology Group Performance Status of 0-1 and were considered suitable candidates for local treatment. The primary endpoint was the feasibility of randomisation, assessed by the randomisation rate (randomised/eligible).
RESULTS: A total of 325 patients with newly diagnosed mPCa were screened, of whom 170 (52%) were eligible. The main reasons for ineligibility included unresectable tumours (42% [65/155]) and inadequate surgical fitness (37% [58/155]). Among eligible patients, 75% were excluded (127/170), mostly due to patient refusal (68% [86/127]) and inclusion in competing studies (21% [27/127]). A total of 43 patients were randomised: 21 to cRP and 22 to SOC, yielding a randomisation rate of 25% (43/170). Randomisation rates were lower than anticipated, limiting feasibility in the present trial setting.
CONCLUSION: Randomising men with newly diagnosed mPCa to RP plus SOC vs SOC alone proved challenging in this Belgian trial. Major barriers to recruitment included limited surgical eligibility and patient refusal. Targeted recruitment strategies or alternative trial designs should be considered.