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Идёт набор NCT04858880

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

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: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation..
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
Швеция
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

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.

Обзор

A randomized phase III trial to study the effect of adding lymph node irradiation in patients with poor prostate-specific antigen (PSA) response during salvage radiotherapy for biochemical recurrence (0.15 ≤ PSA \<0.70 ng/ml) after prostatectomy.

Вмешательства

  • Лучевая терапия Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
    Radiation to the prostate bed with or without addition of radiation of lymph node irradiation (non responders). Patients with PSA response continues radiotherapy as initially planned, and are not followed according to the study protocol, only according to clinical practice.

Первичные конечные точки

  • Failure-free survival (FFS). [Срок оценки: FFS after SRT, with failure defined as either biochemical or clinical recurrence (imaging or biopsy confirmed). FFS is calculated from the randomization date (arms A and B) until end of follow up (month 60 after]
Вторичные конечные точки (8)
  • Systemic treatment-free survival. [Срок оценки: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).]
  • Distant metastasis-free survival. [Срок оценки: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).]
  • Prostate cancer specific survival. [Срок оценки: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).]
  • Overall survival. [Срок оценки: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).]
  • Numbers of patients with acute toxicity (≤ 3 months after end of salvage radiotherapy). [Срок оценки: Up to 3 months after end of salvage radiotherapy.]
  • Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy). [Срок оценки: After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy.]
  • Patients self-esteem of quality of life. [Срок оценки: Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ-C30. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm B), month 12, 24, and 60.]
  • Patients self-esteem of quality of life. [Срок оценки: Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ - PR25. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm, month 12, 24, and 60.]

Критерии участия

Критерии включения

  • Life expectancy > 10 years
  • Age ≥18 years.
  • World Health Organization (WHO) performance status 0-1.
  • Estimated life expectancy >10 years.
  • Histological evidence of prostate cancer in the prostatectomy specimen
  • Primary tumor, regional nodes, metastasis (TNM): any primary tumor (pT), pathologically node-negative (pN0), M0.
  • Biochemical Recurrence (BCR) after prostatectomy, with 0.15 ≤ PSA <0.70 ng/ml.
  • Patients must be able to comply with the protocol.
  • Signed informed consent.
  • Adequate laboratory findings (Haemoglobin (Hb) >90g/L, absolute neutrophil count >1.0x109/L, platelets >75x109/l, bilirubin <1.5x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <1.5 ULN).

Критерии исключения

  • Metastases (regional lymph nodes or distant)\* diagnosed with imaging.
  • Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone).
  • Prior radiotherapy to the pelvis.
  • Prior malignancy other than prostate cancer and basalioma in the past five years.
  • Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) class III-IV congestive heart failure.
  • Severe pulmonary disease.
  • Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.

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

Швеция · 3 центра
  • Jönköping County Hospital, Ryhov — Jönköping
  • Kalmar County Hospital — Kalmar
  • Lund University Hospital — Lund

Идентификаторы

NCT: NCT04858880 · PRO-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗