Идёт набор NCT02971085

Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance

— Наблюдательное 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: Active surveillance.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: 40 лет — 80 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: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

In this study, the investigators aim to establish the prostate cancer active surveillance prospective cohort in our institution, and finally investigate the 5 year rates of reclassification during active surveillance as the primary endpoint of the current study.

Подробное описание

Prostate cancer (PCa) remains one of the most commonly diagnosed malignancies in men worldwide. Early diagnosis and definitive therapy seem to improve oncological outcomes in men with high-risk disease, but significant concerns exist in terms of the overdiagnosis and overtreatment of patients with lower-risk tumors. In this context, active surveillance (AS) has recently emerged as a alternative treatment strategy in PCa patients with low risk cancers. However, published data are based on Western population with different protocol, and therefore; well-controlled data with well-organized and prospective cohort are urgently needed in Korean patients with low-risk PCa because Korean patients have significantly different tumor characteristics compared to Western patients. Here, the investigators have a plan to establish the Seoul National University Enrolled Registry for Prostate Cancer with Active Surveillance, and finally provide the concrete evidence for the clinical outcomes of active surveillance program as the primary therapeutic strategy for low-risk PCa in Korean men.

Вмешательства

Процедура Active surveillance
Active surveillance cohorts are routinely performed the systematic biopsy ≥ 12 cores by TRUS-guided or MR-TRUS fusion according to the protocol based by time path as 1, 2, 4, 7, 10 years and subsequently every 5 years following initial TRUS biopsy.

Первичные конечные точки

Pathological reclassification [Срок оценки: 5 year]

Вторичные конечные точки (6)

active treatment-free survival [Срок оценки: 1, 3, 5, 7, 10 years]
metastasis-free survival [Срок оценки: 3, 5, 10 years]
overall survival [Срок оценки: 3, 5, 10 years]
rates of active surveillance maintenance [Срок оценки: 1, 3, 5, 7, 10 years]
HRQoL scores (measured by EPIC-CP) [Срок оценки: 1, 3, 5, 7, 10 years]
Utility value (measured by EQ-5D-5L) [Срок оценки: 1, 3, 5, 7, 10 years]

Критерии участия

Критерии включения

Men < 80 years
Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores
Pre-Bx PSA ≤ 10ng/ml
PSA density < 0.15ng/ml/ml
Clinical stage T1-2a
Biopsy Gleason score ≤ 6
No. of positive cores ≤ 2
Maximum cancer involvement in any one core ≤ 20%.
No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T)
Participants must be willing to attend the follow-up visits - T1a-b disease should be confirmed by systematic TRUS-Bx ≥ 10 cores