Идёт набор NCT05478694

Outcomes of Focal Ablation for Prostate Cancer

— 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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: 18 лет — 90 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: США
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

Prospective Single Institutional Study Evaluating the Outcomes for Patients Undergoing Ablative Therapies in the Management of Clinically Localized Prostate Cancer in the Primary and Salvage Setting

Обзор

This study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.

Подробное описание

There are several commercially available standard of care treatments available for local therapy of the prostate. Ablative therapies may be delivered via a whole gland or focal approach by systems including cryoablation (CA), brachytherapy, irreversible electroporation (IRE), high intensity focused ultrasound (HIFU), MRI-guided transurethral ultrasound ablation (TULSA) procedure or future novel prostate ablation systems.

These are single, outpatient treatments lasting between 2-4 hours and include treatment planning and energy delivery under guidance and are either administered via transperineally approach (cryoablation, IRE, brachytherapy) or via the urethral (TULSA-Pro) or rectum (HIFU).

This study protocol will not include experimental therapy and the enrolled subjects will undergo the ablative therapy as part of their standard of care treatment.

Первичные конечные точки

Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (primary setting) [Срок оценки: 12 months post treatment]
Oncologic outcomes as assessed by the rate of advancement to systemic therapy or radical salvage therapies (primary setting) [Срок оценки: 3 years post treatment]
Oncologic outcomes as assessed by the rate of negative in-field biopsy at 12 months (salvage setting) [Срок оценки: 12 months post treatment]
Oncologic outcomes as assessed by the rate of progression to systemic therapy or radical salvage therapies (salvage setting) [Срок оценки: 3 years post treatment]
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (primary setting) [Срок оценки: Baseline and 12 months post treatment]
Change in urinary function as measured by International Prostate Symptom Score (IPSS) questionnaire (salvage setting) [Срок оценки: Baseline and 12 months post treatment]
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (primary setting) [Срок оценки: Baseline and 12 months post treatment]
Change in erectile function as measured by International Index of Erectile Function (IIEF-5) score questionnaire (salvage setting) [Срок оценки: Baseline and 12 months post treatment]

Вторичные конечные точки (5)

Number of participants with adverse events or short-term complications (primary setting) [Срок оценки: 30 days post treatment]
Number of participants undergoing combined treatment of the transitional zone (TZ ) due to bladder outlet obstruction caused by Benign prostatic hyperplasia (BPH) [Срок оценки: Baseline and 12 months post treatment]
Number of participants with adverse events or short-term complications (salvage setting) [Срок оценки: 30 days post treatment]
Number of participants with adverse events or long-term complications (primary setting) [Срок оценки: 3 years post-treatment]
Number of participants with adverse events or long-term complications (salvage setting) [Срок оценки: 3 years post-treatment]

Критерии участия

Критерии включения

Men with histologically confirmed prostate adenocarcinoma diagnosed on prostate biopsy
Men with histologically confirmed local recurrence of prostate cancer diagnosed on prostate biopsy and standard of care imaging excluding locoregional or metastatic disease
Age 18-90 years.
Life expectancy > 1 year
Ability to understand and the willingness to sign a written informed consent.