Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])

Официальное название

A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy

Обзор

The primary purpose of this study is to compare the quality of life (QOL) reported by prostate cancer patients 2 years after treatment with ultra-hypofractionated post-prostatectomy radiation therapy (also known as stereotactic body radiation therapy \[SBRT\]) versus the self-reported QOL of those treated with moderately hypo-fractionated post-prostatectomy radiation (a current standard of care option).

Подробное описание

Conventional or moderately hypo-fractionated radiation therapy are the current standard of care treatment options for men receiving post-prostatectomy radiation therapy. These treatment regimens typically span 4-8 weeks, representing a high burden of therapy, which may result in decreased utilization of salvage radiotherapy, the only potentially curable treatment for men with relapsed disease following prostatectomy. Ultra-hypofractionated radiation therapy (also known as stereotactic body radiation therapy \[SBRT\]) would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden.

Вмешательства

• Лучевая терапия Ultra-hypofractionated radiation therapy
  34 Gy in 5 fractions to prostate bed, every other day, M-F, \~2 weeks (25 Gy in 5 fractions to pelvic lymph nodes if included)
• Лучевая терапия Moderately Hypo-fractionated Radiation Therapy
  55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)

Первичные конечные точки

• Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline [Срок оценки: 2-years post-treatment]

Вторичные конечные точки (9)

• Patient reported GU quality of life (QOL) up to 60 months [Срок оценки: 60 months post-treatment]
• Patient reported GI quality of life (QOL) up to 60 months [Срок оценки: 60 months post-treatment]
• Treatment related toxicity - acute [Срок оценки: ≤ 90 days after treatment completion]
• Treatment related toxicity - late [Срок оценки: >90 days after treatment completion, up to 5 years]
• Time to progression [Срок оценки: up to 5 years]
• Rate of biochemical failure [Срок оценки: up to 5 years]
• Local failure, Regional failure, Distant metastases [Срок оценки: up to 5 years]
• Prostate cancer specific survival [Срок оценки: up to 5 years]
• Overall survival [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

• Men age ≥ 18 with histologically confirmed prostate cancer after radical prostatectomy with a PSA ≥ 0.1 ng/mL
• Interval between prostatectomy and planned radiation therapy start date ≥ 6 months
• KPS ≥ 70
• Patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are ≤ 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy)
• Ability to complete the EPIC-26 quality of life questionnaire
• Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology
• Ability to understand and the willingness to sign a written informed consent.

Критерии исключения

• Prior history of pelvic radiation therapy
• History of moderate/severe or active Crohn's disease or ulcerative colitis
• History of bladder neck or urethral stricture
• Evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels
• Initiation of androgen deprivation therapy with a LHRH / GnRH agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-LHRH / GnRH agonist or antagonist androgen deprivation or anti-androgen therapy
• History of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer
• Any condition that in the opinion of the investigator would preclude participation in this study

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 · 1 центр

• University of Michigan Rogel Cancer Center — Ann Arbor

Идентификаторы

NCT: NCT05038332 · UMCC 2021.046 · HUM00200905

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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