Neoadjuvant Embolization and Cytoreduction in Prostate Cancer

Официальное название

Neoadjuvant Embolization and Cytoreduction to Ameliorate Radiotherapy Toxicity in Prostate Cancer

Обзор

The goal of this clinical trial is to find out whether prostate artery embolization (PAE) can help prevent or lessen urinary side effects caused by radiotherapy (RT) in people with prostate cancer, especially those who have larger prostates or urinary symptoms before treatment. The main questions this study aims to answer are: * Does PAE before RT reduce the severity of urinary side effects from RT? * Does PAE affect the rates of genitourinary (GU) or gastrointestinal (GI) side effects after RT? Researchers will look at changes in urinary symptoms from the start of the study to 6 months after PAE. They will also record any GU or GI side effects related to RT. Participants will receive prostate artery embolization before starting radiotherapy, and complete questionnaires and assessments about GU and GI functions before and after treatment.

Вмешательства

• Процедура Prostatic Artery Embolization
  PAE is a minimally invasive procedure that involves embolizing the arteries supplying the prostate, leading to its shrinkage.

Первичные конечные точки

• Change in LUTS symptoms measured by the IPSS at 6 months post-PAE [Срок оценки: From enrollment to the 12 months after PAE]

Вторичные конечные точки (10)

• Rates of Grade ≥2 GU and GI RT toxicity as assessed by CTCAE v5.0 [Срок оценки: From enrollment to 12 months after PAE]
• Rates of PAE intraoperative and postoperative adverse events as assessed by Clavien-Dindo and CTCAE v5.0 [Срок оценки: From the start of PAE to 12 months after PAE]
• Prostatic Specific antigen (PSA) at 6 months post-PAE [Срок оценки: From enrollment to 12 months after PAE]
• Change in prostate volume calculated by TRUS at 6 months post-PAE [Срок оценки: From enrollment to 12 months after PAE]
• Change in peak urinary flow rate (Qmax, ml/s) at 6 months post-PAE [Срок оценки: From enrollment to 6 months after PAE]
• Change in postvoid residual urine (PVR, ml) at 6 months post-PAE [Срок оценки: From enrollment to 6 months after PAE]
• Change in bladder and rectum mean RT dose from pre-PAE to pre-RT simulation scan [Срок оценки: From pre-PAE simulation scan to pre-RT simulation scan]
• Urinary quality of life assessed by IPSS QoL scores [Срок оценки: From enrollment to 12 months after PAE]
• Rate of local re-intervention for LUTS [Срок оценки: From enrollment to 6 months after PAE]
• Erectile dysfunction assessed by the International Index of Erectile Function (IIEF-5) questionnaire [Срок оценки: From enrollment to 12 months after PAE]

Критерии участия

Критерии включения

• Histologically confirmed prostate adenocarcinoma with planned RT to the prostate
• Baseline (pre-PAE) prostate volume ≥ 50 cc
• Baseline (pre-PAE) IPSS ≥ 15
• If planned or ongoing ADT and/or 5-alpha reductase inhibitor (5ARI), patient should be on therapy for at least 12 weeks, and meet prostate volume and pre-PAE IPSS criteria at the time of enrollment.

Критерии исключения

• Baseline (pre-PAE) IPSS storage/voiding ratio ≥ 1
• Previous prostate treatment (TURP, Laser therapies, MISTs)
• Chronic urinary retention requiring use of indwelling urinary catheter.
• Neurogenic bladder or other neurological disorder that is impacting bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injuries, etc.).
• Active urinary tract infections or recurrent urinary tract infections (>2/year), prostatitis, or interstitial cystitis.
• Receipt of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week of study treatment AND patient has not been on the same drug dosage for 6 months with a stable voiding pattern.
• Hypersensitivity reactions to contrast material not manageable with prophylaxis.
• Glomerular filtration rates less than 40 mL/min (unless on dialysis).
• Bilateral internal iliac arterial occlusion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07251829 · NECTAR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗