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Набира участници Не е приложимо NCT05155501

Clinical Trial of Approaches to Prostate Cancer Surgery

Не е приложима фаза (напр. обсервационно)
Заболявания: Prostate Cancer

Спонсор: Weill Medical College of Cornell University

Налично на: БГ
Обобщение
This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy. The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.
Описание
Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common. Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy. This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.
Кой може да участва
Inclusion Criteria: * Male sex * Age ≥40 years or ≤80 years * Scheduled for radical prostatectomy for clinically localized prostate cancer * Able to read and speak English or Spanish * Willingness to sign informed consent and adhere to the study protocol Exclusion Criteria: * Prior major pelvic surgery or radiotherapy * Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)
Интервенции
Robot-assisted radical prostatectomy (RP)
PROCEDURE
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
PROCEDURE
Места на провеждане 9
САЩ (9)
Johns Hopkins University
Baltimore , Maryland
Beth Israel Deaconess Medical Center (BIDMC)
Boston , Massachusetts
Northwestern University
Chicago , Illinois
Beckman Research Institute of City of Hope
Duarte , California
Radhika Nagalla, PharmD
NewYork-Presbyterian Queens
Flushing , New York
Hackensack Meridian Health
Hackensack , New Jersey
Memorial Sloan Kettering Cancer Center
New York , New York
Melissa McCarter
Weill Cornell Medicine
New York , New York
Georgetown University
Washington D.C. , District of Columbia
Keith Kowalczyk, MD
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
40 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
15.05.2023
Крайна дата
01.07.2028
Регистрационен номер
NCT05155501
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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