Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy

Официальное название

A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer

Обзор

The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.

Подробное описание

The purpose of this study is to determine if prostate capsule-sparing cystectomy improves functional outcomes without compromising the oncologic outcomes in patients with bladder cancer. The comparison arm will be patients undergoing nerve-sparing radical cystectomy. Participants will be randomized to receive either a nerve-sparing radical cystectomy or a prostate capsule-sparing radical cystectomy. Patients will be monitored following standard of care guidelines every 3-months post-operatively up to and including 24 months post-operatively. As part of standard of care post-operative follow-up patients will have routine history and physical exams, urine cytology, urine culture, Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), and Prostate Specific Antigen (PSA). Standard of Care diagnostic imaging will also occur. The Sexual Health Inventory for Men (SHIM) Questionnaire will be given to patients 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post-operatively. To measure urinary function in patients who receive orthotopic neobladder, the Validated Pad Questionnaire will be given 6-weeks post-operatively and every 3-months post-operatively up to and including 24-months post operatively. Adverse Events will be monitored in both groups as defined by the CTCAE 5.0 guidelines.

Вмешательства

• Процедура Prostate capsule-sparing radical cystectomy
  Patients randomized to this arm will receive the prostate capsule-sparing surgery performed in the form of standard simple prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.
• Процедура Nerve sparing radical cystectomy
  Patients randomized to this arm will receive the nerve-sparing surgery will be performed in the form of the standard nerve-sparing radical prostatectomy. Patients will also have a cystectomy with one of the following urinary diversions: ileal conduit, Indiana Pouch, or orthotopic neobladder.

Первичные конечные точки

• Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM) [Срок оценки: Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op]

Вторичные конечные точки (5)

• Change in urinary function in patients with orthotopic neobladder as assessed by the Validated Pad Questionnaire [Срок оценки: Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively , 24-months post-op]
• Change in overall patient survival [Срок оценки: Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op]
• Change in disease specific status [Срок оценки: Baseline, 6 weeks-post operatively, 3-months post-operatively, 6-months post-operatively, 9-months post-operatively, 12-months post-operatively, 15-months post-operatively, 18-months post-operatively, 21-months post-operatively, 24-months post-op]
• Soft tissue surgical margin rate as assessed by pathology [Срок оценки: Up to 4-weeks after surgical intervention]
• Safety as assessed by adverse events experienced by study participants [Срок оценки: Up to 24-months post-operative]

Критерии участия

Критерии включения

• Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy
• Variant histologies of bladder cancer permitted
• Neoadjuvant therapy permitted
• Age > 18 years old
• Ability to understand and willingness to sign a written informed consent document

Критерии исключения

• Patients that are not candidates for cystectomy
• Moderate to severe erectile dysfunction with SHIM score <17
• Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra
• Prior pelvic radiation
• Confirmed prostate cancer:
• Patients with abnormal Digital rectal exam (DRE), PSA >3 or Prostate Imaging Reporting \& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer
• Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:
• ≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age
• ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y
• ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age
• ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed
• Patients with Lynch syndrome

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Sibley Memorial Hospital — Washington D.C.
• Johns Hopkins Hospital — Baltimore

Идентификаторы

NCT: NCT05792722 · IRB00345549

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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