Набор скоро начнётся NCT07591051

Weekly Online CT or MR Adaptive Definitive SBRT for Very High Risk Localized or Regionally Metastatic Prostate Cancer

Без фазы С лечением Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: weekly CT or MR online adaptive definitive SBRT.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия, Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Weekly Online CT or MR Adaptive Definitive SBRT for Very High Risk Localized or Regionally Metastatic Prostate Cancer (HARP)

Обзор

This interventional prospective multicenter international study will include 54 patients with very high-risk localized (cN0 cM0) or regional (i.e. cN1 cM0) prostate cancer according the NCCN criteria. Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. In the case of regional lymph nodes, a simultaneous integrated boost (SIB) of involved lymph nodes will be performed with 5 x 6.5 Gy. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL with 5 x 9 Gy can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints. This study is classified as risk category A according to ClinO, Art. 61, as stereotactic radiotherapy (SBRT) for localized or regional prostate cancer has been extensively evaluated in prospective interventional trials and is considered an established therapeutic modality. Weekly CT- or MR-guided online adaptive SBRT to the prostate and elective pelvic lymph nodes with 5 × 5 Gy is, however, not yet routinely implemented for this specific patient population. A diagnostic high field MRI during radiotherapy, e.g. week 3 is optional. Follow-up is also according to standard of care (except for patient reported outcome measure using QLQ-C30 and QLQ-PR25 and a diagnostic MRI at 9 months after SBRT (optional), and 12 months in the case of an image non-complete response at 9 months (optional).

Вмешательства

Устройство weekly CT or MR online adaptive definitive SBRT
Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. In the case of regional lymph nodes, a simultaneous integrated boost (SIB) of involved lymph nodes will be performed with 5 x 6.5 Gy. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL with 5 x 9 Gy can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.

Первичные конечные точки

Feasibility- a successful delivery of CT or MR-informed SBRT per fraction [Срок оценки: from Day 1 of treatment up to 7 weeks until end of treatment]
Safety - Adverse events [Срок оценки: ≥ 3 months to within 1 year after completion of SBRT]

Вторичные конечные точки (12)

Biochemical progression-free survival [Срок оценки: from Day 1 up to 5 years after treatment]
Castration-resistant free survival [Срок оценки: from Day 1 up to 5 years after treatment]
Patients Quality of Life EQ-5D-5L from the European Organisation for Research and Treatment of Cancer [Срок оценки: from Day 1 up to end of study until 5 years]
Patients Quality of Life QLQ-C30 from the European Organisation for Research and Treatment of Cancer [Срок оценки: From Day 1 up to end of study (up to 5 years)]
Adverse events [Срок оценки: from Day 1 until 5 years or end of Study]
Patients overall survival [Срок оценки: from Day 1 until Progression or death whichever comes first until 5 years]
Patient overall treatment - Patient treatment workflow duration (time from MRI scan start to completion of treatment) [Срок оценки: from Day 1 start of therapy, weekly until end of treatment up to 7 weeks]
Other Toxicities [Срок оценки: Day 1 of Treatment for up to 5 years or until death whichever comes first]
Dosimetry difference [Срок оценки: from Day 1 of treatment start until end of treatment up to 7 Weeks]
Anatomy changes assessed on magnetic resonance imaging (MRI) [Срок оценки: from Day 1 of treatment up to 7 weeks]
Comparison of Patient treated and not treated [Срок оценки: from Day 1 until 5 Years of study or death]
Patient compliance [Срок оценки: from Day 1 until 5 Years / end of Study]

Критерии участия

Inclusion criteria include:

Very high risk localized defined (cN0) according to NCCN guidelines consisting of ≥2 of the following:

cT3 disease and/or
Gleason 8-10 and/or
PSA ≥40 (the baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors) OR
Regionally metastatic prostate cancer (cN1, any T, any Gleason, any PSA) according to NCCN guidelines consisting of ≤3 lymph node metastases of any of the following:

Obturator
Internal iliac (hypogastric)
External iliac nodes
Presacral nodes
Common iliac (below iliac bifurcation)
Periprostatic/Perivesical AND
Good to moderate performance status (WHO 0-2)
Written informed consent.
A PSMA PET and multiparametric MRI is mandatory according to staging guidelines.
Age ≥ 18 years

Exclusion criteria include:

≥4 regional lymph nodes
Patients with cT4 disease (tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall)
Previous RT to the pelvis or prostate
Previous radical prostatectomy
Large body size that would not fit into the MRI-simulator bore
Presence of distant metastases (i.e. cM1)

Non-regional lymph nodes (M1a):
Common iliac
Para-aortic / retroperitoneal
Inguinal
Mediastinal or supraclavicular
Mesorectal
Other
Bone metastases (M1b)
Other sites (M1c)
Contraindications to CT or MR-adaptive SBRT (e.g., pacemakers, severe claustrophobia).
Severe comorbidities that may interfere with treatment or follow-up (e.g. inflammatory bowel disease)
Significant concomitant diseases (e.g. hepatic dysfunction, cardiovascular disease, etc.);
Inability to follow procedures or insufficient knowledge of project language, inability to give consent.
Participation in a clinical trial, which might influence the results of this project.
Enrolment of the investigator, his/her family members, employees and other dependent persons.
Severe GU or GI symptoms (e.g., recent urinary retention or diarrhea ≥ grade 3 or obstipation to CTCAE v.5.0).
Severe urinary symptoms (prostate volume >60mL and/or IPSS >12)

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

Здоровые добровольцы: Нет