Идёт набор NCT06705803

Prostate Ablation Registry and Database for Information, Surveillance, and Evaluation (PARADISE)

— 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: Prostate Ablation.
Кому может быть актуально: Состояния в реестре: Prostate Cancer. Базовые параметры: от 22 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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Обзор

Prostate cancer (PCa) is the most commonly diagnosed non-cutaneous cancer of men in the world. In 2023 alone, it is estimated that 288,300 US men will be diagnosed with prostate cancer and 34,700 will die from the disease despite the approval of multiple systemic agents. Due to advances in screening and imaging technology, PCa is now detected much earlier in its disease course. Prostate gland ablation for prostate cancer might provide the option for a "middle" ground between active surveillance (AS) and radical therapy by destroying prostate cancer in a minimally invasive or non-invasive fashion and thus limiting the morbidity. This treatment strategy is increasingly being offered to patients due to low morbidity but the data on long term oncologic efficacy and side effect profile is lacking for such a treatment strategy. The purpose of this study is to create a database and prospective registry for data collection on patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. Patients with biopsy-proven prostate cancer of any Gleason Grade will be entered into the registry as long as prostate ablation is used as the prostate cancer management modality. Historical data from 2017 to the present time will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.

Вмешательства

Процедура Prostate Ablation
Patients with prostate cancer undergoing prostate ablation for the management of prostate cancer.

Первичные конечные точки

Number of Participants with descriptive summarization of Prostate specific antigen (PSA) and its derivatives to represent clinicopathologic, interventions, and oncological outcomes [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]
Number of Participants with descriptive summarization of prostate biopsy [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]
Number of Participants with descriptive summarization of biomarkers [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]
Number of Participants with descriptive summarization of imaging findings [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]
Number of Participants with descriptive summarization of urination function [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]
Number of Participants with descriptive summarization of bowel function [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]
Number of Participants with descriptive summarization of sexual function [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]
Number of Participants with descriptive summarization of the overall quality of life parameters [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]

Вторичные конечные точки (1)

Incidence of Treatment-Emergent Adverse Events of prostate gland ablation in patients with localized prostate cancer measured on a continuous scale. [Срок оценки: Follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total follow-up after prostate cancer management.]

Критерии участия

Критерии включения

Male sex
≥22 years of age
Histologic diagnosis of prostate cancer
Scheduled to undergo or have already undergone ablation of the prostate as part of routine clinical care or any ongoing clinical trials
Prostate ablation performed with any of the following energy sources: cryotherapy, high-intensity focused ultrasound, irreversible electroporation, laser, microwave, radiofrequency ablation, or photodynamic therapy. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins