Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy.

Обзор

This is a a randomized phase II/III trial comparing salvage SBRT with standard of care (SOC) regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy.

Подробное описание

This is a multicentric randomized seamless phase II/III study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed.

All subjects will be randomly assigned in a 1:1 ratio:

1. Experimental arm: Radiotherapy treatment in 5 fractions. 2. Control arm: Radiotherapy treatment within a normofractionated or mildly hypofractionated schedule. For the control arm, each participating center can choose between a normofractionated schedule (32 to 35 treatment sessions) and a moderately hypofractionated schedule (20 sessions).

Вмешательства

• Лучевая терапия Stereotactic body radiotherapy (SBRT)
  5 fractions of SBRT to the prostate bed with or without whole pelvic radiotherapy Treatment every other day.
• Лучевая терапия SOC RT
  Standard salvage radiotherapy to the prostate bed with or without whole pelvic radiotherapy. Each participating centre can specify upfront which RT schedule will be used in the control arm, with the choice between the following schedules: * Hypofractionated: 20 fractions (Daily treatment (OTT 4-5 weeks)) * Normofractionated: 32-35 fractions (Daily treatment (OTT 7-8 weeks))

Первичные конечные точки

• SBRT impact on patient-reported GI and GU symptoms [Срок оценки: 2 years post treatment]

Вторичные конечные точки (8)

• Patient Reported Outcomes [Срок оценки: at end of RT and following time-points counted from start of RT : 4-7 weeks (only in experimental arm), 3 months, 6 months, 1 year and yearly up to 5 years]
• Ccost-utility during radiotherapy [Срок оценки: during radiotherapy]
• Physician-scored toxicity [Срок оценки: up to 5 years]
• Blood lymphocyte evolution between study arms [Срок оценки: 5 years]
• To compare biochemical progression-free survival (bPFS) to historical control and between study arms [Срок оценки: 5 years]
• To compare local and regional recurrences between study arms, up to 5 years. [Срок оценки: 5 years]
• To compare Overall survival (OS) between study arms, up to 5 years. [Срок оценки: 5 years]
• To compare distant metastases-free survival (dmFS) between study arms [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Localized adenocarcinoma (cN0M0) of the prostate treated primarily with radical prostatectomy with definitive intent.
• Either persistent PSA after prostatectomy (PSA ≥ 0.1 ng/mL at least 6 weeks after prostatectomy), or biochemical progression (two consecutive rising PSA amounts with a PSA >0.1 ng/mL , or three consecutive PSA rises)
• WHO PS 0-1
• Age ≥18 years
• Ability to understand and willingness to sign a study-specific informed consent prior to study entry
• Ability to understand and answer the EPIC-26 form in one of the languages available

Критерии исключения

• Patients with a pT4 tumor at prostatectomy
• Patients with previously pathologically confirmed N1
• Patients with macroscopically involved margin at surgery (R2)
• Patients with a history of distant metastases
• Patients with a recurrence visible on imaging (local, pelvic, or distant). Pelvic nodes with a small diameter >1cm and/or positive on PSMA without other explanation, are considered as a pelvic recurrence.
• Latest PSA > 2ng/ml
• Patients with a IPSS >20
• Gleason 10 tumor
• Prior history of high-intensity focused ultrasound ablation (HIFU), cryosurgery or brachytherapy of the prostate
• Prior pelvic radiotherapy
• Prior hormonal therapy started more than 6 weeks before randomization
• History of inflammatory bowel disease, ataxia telangiectasia, prior rectal or bladder surgery.
• Other active malignancy, except non-melanoma skin cancer, superficial bladder cancer, or malignancies with a documented disease-free survival for a minimum of 3 years before randomization.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 13 центров

• AZorg — Aalst
• Ziekenhuis Aan de Stroom (ZAS) — Antwerp
• AZ Sint Jan — Bruges
• Jules Bordet Institute, H.U.B — Brussels
• Ziekenhuis Oost-Limburg (ZOL) Campus Sint-Jan — Genk
• UZ Gent — Ghent
• Jessa Ziekenhuis — Hasselt
• AZ Groeninge — Kortrijk
• … и ещё 5 центров

Идентификаторы

NCT: NCT06523634 · CE3764

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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