Идёт набор NCT04794777

Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer

Фаза III 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: Individualised therapy, Standard salvage therapy.
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

A Randomized Trial Comparing Conventional "Salvage" Radiotherapy and Individualized 68Ga-PSMA-11 or 18F-PSMA-1007 PET/CT Targeted Treatment in Patients With Biochemical Recurrence After Prostate Cancer Surgery

Обзор

Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT. Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact. In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.

Вмешательства

Комбинированный продукт Individualised therapy
Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed. Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET p
Лучевая терапия Standard salvage therapy
Standard salvage radiotherapy

Первичные конечные точки

Primary PSA progression free survival [Срок оценки: Throughout the study, approximately 10 years.]

Вторичные конечные точки (4)

Time to metastasis [Срок оценки: At 5, 7 and 10 years]
Prostate cancer specific survival [Срок оценки: At 5, 7 and 10 years]
Time to secondary treatment [Срок оценки: At 5, 7 and 10 years]
Differences in quality of life recorded using Patient Reported Outcome Measure (PROM) [Срок оценки: Baseline, 6, 12, 36 and 60 months after completed treatment.]

Критерии участия

Критерии включения

Patients previously treated for prostate cancer with radical prostatectomy and now having a biochemical recurrence (BCR) defined as: PSA >0.2 <2.0 ng/mL, and increasing measured twice.
Multidisciplinary conference (MDK) decision to offer the patient SRT
Signed Informed Consent