MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)
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: Single-fraction SBRT.
- Кому может быть актуально
- Состояния в реестре: Prostate Cancer, Oligo-metastatic Prostate Carcinoma, Oligometastatic Cancer, Nodal Oligorecurrent 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
- Дания
- 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
Improved MR-Guided Single-fraction Stereotactic Sblative Radiotherapy in Pelvic and Abdominal Nodal Oliorecurrent Prostate Cancer
Обзор
This single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative treatment. Participants receive one fraction of 24 Gy delivered with MR-guided stereotactic body radiotherapy (SBRT), which uses MRI to visualise the tumour and surrounding organs during treatment. The main goal is to assess safety (severe side effects). The trial also evaluates local tumour control, longer-term side effects, time until hormone (androgen deprivation) therapy is needed, survival, and quality of life. The trial aims to enrol 48 patients.
Подробное описание
PINPOINT is a prospective, investigator-initiated, single-centre, single-arm phase 2 trial of single-fraction MR-guided SBRT in patients with nodal oligorecurrent prostate cancer. Eligible men have PSMA-PET/CT-verified nodal relapse in the pelvis or abdomen following curatively intended local treatment.
All patients are simulated with MRI in treatment position and treated with 24 Gy in 1 fraction to the gross tumour volume (GTV) using inverse-planned step-and-shoot IMRT on an MR-linac. No CTV margin is added (CTV = GTV); PTV margins account for motion and set-up uncertainty. Normal-tissue constraints are prioritised over target coverage.
The primary endpoint is cumulative CTCAE v5 grade ≥4 treatment-related toxicity within 6 months. Sample size follows a Simon two-stage design (H0: grade 4-5 TRAE rate 15%; H1: 4%; one-sided α = 5%, power 80%), with an interim analysis after 6-month follow-up of the first 16 patients and a total of 48 patients. Follow-up continues for 5 years. Toxicity (CTCAE v5), quality of life (EQ-5D-5L, EORTC QLQ-C30) and patient-reported outcomes (PRO-CTCAE) are collected at baseline and through follow-up; PSA and PSMA-PET/CT (on rising PSA) follow standard of care.
Вмешательства
- Лучевая терапия Single-fraction SBRT
Participants will receive 24 Gy in 1 fraction to a lymph node.
Первичные конечные точки
- Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events [Срок оценки: Within 6 months after completion of radiotherapy]
Вторичные конечные точки (9)
- Number of participants with late adverse events (CTCAE v5.0) [Срок оценки: 1, 1,5, 2, 3 and 5 years]
- Percentage of participants free from local progression (PSMA-PET/CT-verified), estimated by time-to-event analysis [Срок оценки: From radiotherapy until local progression or last follow-up, up to 5 years]
- Median clinical progression-free survival [Срок оценки: From radiotherapy up to 5 years]
- Median time to initiation of palliative ADT (ADT-free survival) [Срок оценки: From inclusion up to 5 years]
- Number of participants with acute adverse events (CTCAE v5.0), by maximum grade [Срок оценки: Within 6 months after radiotherapy]
- Median overall survival [Срок оценки: From inclusion up to 5 years]
- Mean change from baseline in EQ-5D-5L index (utility) score [Срок оценки: Baseline, 2 weeks, 3,6 and 12 months]
- Mean change from baseline in EORTC QLQ-C30 Global Health Status / QoL scale score [Срок оценки: Baseline, 2 weeks, 3, 6 and 12 months]
- Number of participants reporting symptomatic adverse events as assessed by PRO-CTCAE [Срок оценки: Baseline, 2 weeks, 3,6 and 12 months]
Критерии участия
Критерии включения
- Age ≥ 18 years
- Signed informed consent
- Histologically proven initial diagnosis of adenocarcinoma of the prostate
- ECOG performance status 0-2
- Biochemical recurrence after curatively intended local treatment (radical prostatectomy and/or radiotherapy), with PSMA-PET/CT-verified nodal relapse in the pelvis or abdomen
- Any additional sites of disease beyond the protocol-specified target lymph nodes must be considered suitable for ablative treatment
- Life expectancy > 6 months
- Lymph node size ≤ 2 cm
Критерии исключения
- Medical contraindications to MRI
- Inability to tolerate the physical set-up required for SABR
- Overlap between prior radiation fields and the current target area leading to high risk of clinically significant normal-tissue injury
- Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)
- Uncontrolled intercurrent illness
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Department of Oncology, Odense University Hospital — Odense
Идентификаторы
NCT: NCT07635108 · OP-2499 · S-20250058