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Идёт набор NCT07623941

CUIMC Focal Therapy Registry

— 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: Focal therapy.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: 40 лет — 85 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
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Официальное название

Columbia University Prostate Cancer Focal Therapy Registry

Обзор

Patients undergoing high intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) for prostate cancer will be invited to consent to have their data collected in a detailed comprehensive system to record and store patient, disease, and treatment-related characteristics. No treatment will be given, no randomization will occur, and each patient seen and treated for prostate cancer specifically with HIFU and IRE method in the Department of Urology division of Urologic Oncology within Columbia University Irving Medical Center will be eligible to be enrolled in the database.

Подробное описание

The primary objective of this study is to evaluate surgical, oncologic, functional, and quality-of-life outcomes following focal treatment with high-intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) in patients with localized prostate cancer. The study will assess the feasibility and efficacy of focal prostate tissue ablation using these treatment approaches.

Multiparametric MRI will be used to identify regions of interest within the prostate and to support treatment planning and targeting. The investigators aim to further characterize outcomes after focal ablation with HIFU and IRE, including treatment-related effects, cancer control, and patient-reported quality-of-life measures.

In addition, the study will examine factors associated with ablation success, including targeting strategy and post-treatment assessment methods. Follow-up biopsy protocols will also be evaluated to determine their role in assessing treatment efficacy and confirming lesion ablation after focal therapy.

Вмешательства

  • Процедура Focal therapy
    Focal ablation of prostate cancer using IRE or HIFU

Первичные конечные точки

  • Failure free survival [Срок оценки: 10 years]

Критерии участия

Критерии включения

  • Organ-confined prostate adenocarcinoma diagnosed by MRI/ultrasound fusion biopsy within a multiparametric MRI derived region of interest
  • Clinical stage T2cN0M0 (radiological T3a is permitted)
  • Multi-parametric MRI at New York-Presbyterian hospital (NYPH) within the past 6 months demonstrating region of interest suspicion level 2 by the Prostate Imaging Reporting and Data System version 2.0 scoring criteria
  • Transrectal or transperineal ultrasound-guided biopsy with 10 template biopsy cores and 2 MRI-ultrasound fusion targeted biopsy cores from the above MRI-derived region of interest demonstrating:
  • histologically confirmed prostate adenocarcinoma from targeted biopsy cores
  • unilateral Gleason score 4+3 prostate adenocarcinoma
  • Age 40 to 85 years of age
  • Subjects choose to undergo focal therapy and decline alternative treatment (such as active surveillance, radical prostatectomy, radiation therapy, cryosurgery or hormone therapy)
  • Signed informed consent

Критерии исключения

  • Any Gleason score 4+4 outside an MRI-identified region of interest
  • Prostatic calcifications which in the opinion of the investigator would impede delivery of the energy to tumor in patients choosing HIFU
  • Any medical condition that would compromise the subject's ability to safely participate in the study
  • American Society of Anesthesiologists (ASA) criteria of IV or higher
  • Active urinary tract infection
  • Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
  • Active, uncontrolled inflammatory bowel disease
  • Urinary tract or rectal fistula
  • Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery
  • Any contraindication to MRI (such as contrast allergy, sever claustrophobia, MRI-incompatible prosthesis)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Columbia University Irving Medical Center — New York

Идентификаторы

NCT: NCT07623941 · AAAU8649

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗