Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Официальное название

Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity

Обзор

This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.

Вмешательства

• Устройство Daily adaptive SBRT with urethral sparing
  The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.

Первичные конечные точки

• Patient-reported acute urinary toxicity [Срок оценки: 90 days after end of SBRT]

Вторичные конечные точки (12)

• Freedom from biochemical recurrence [Срок оценки: 5 years after end of SBRT]
• Patient-reported quality of life issues related to prostate cancer. [Срок оценки: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT]
• Patient-reported erectile dysfunction symptoms [Срок оценки: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT]
• Patient-reported urinary symptoms [Срок оценки: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT]
• Patient-reported overall quality of life [Срок оценки: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT]
• Physician-reported toxicities [Срок оценки: During treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT]
• Alpha-blocker medication use [Срок оценки: Baseline; during treatment; 6 weeks, 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, and 5 years after end of SBRT]
• Metastasis-free survival [Срок оценки: 5 years after end of SBRT]
• Prostate-cancer specific mortality [Срок оценки: 5 years after end of SBRT]
• Overall survival [Срок оценки: 5 years after end of SBRT]
• Workflow metrics of adaptive SBRT for prostate cancer [Срок оценки: 2 weeks after start of SBRT]
• Target and OAR dosimetry [Срок оценки: 2 weeks after start of SBRT]

Критерии участия

Критерии включения

• Patient has NCCN low or intermediate risk prostate cancer that is biopsy proven.
• Prostate volume is ≤80cc as assessed by MRI prior to radiotherapy.
• AUA/IPSS score is ≤ 15.
• ECOG performance status is ≤2 (or Karnofsky score is ≥60%).
• Patient has no PIRADS 4 or 5 lesion on prostate MRI contacting the urethra (determined at physician discretion).
• Patient has the ability to complete required patient questionnaires.
• Patient age ≥ 18 years (or greater than the local age of majority).
• Patient has the ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

• Patient has baseline grade ≥3 GI or GU toxicity
• Patient has had prior overlapping pelvic radiotherapy.
• Patient has had prior transurethral resection of the prostate, prostate HIFU, or cryoablation.
• Patient has node positive prostate cancer.
• Patient has extracapsular extension (capsular abutment is permitted).
• Patient has active inflammatory bowel disease or active collagen vascular disease.
• Patient cannot undergo prostate MRI.
• Patient cannot undergo prostate fiducial marker placement.
• Patient has ongoing receipt of cytotoxic chemotherapy (androgen deprivation therapy is allowed).

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

Лечение

Центры проведения

США · 5 центров

• Duarte Cancer Center — Duarte
• City of Hope Orange County Lennar Foundation Cancer Center — Irvine
• Brigham and Women's Hospital — Boston
• Washington University in St. Louis — St Louis
• Fox Chase Cancer Center — Philadelphia

Германия · 2 центра

• Klinikum der Landeshauptstadt Stuttgart gKAöR — Stuttgart
• Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital) — Homburg

Испания · 1 центр

• Hospital Universitario de Navarra — Pamplona

Идентификаторы

NCT: NCT05804318 · VAR-2021-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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