5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)

Официальное название

Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment

Обзор

We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.

Подробное описание

Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiotherapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiotherapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centers of British Columbia Cancer Agency, with each center choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.

Вмешательства

• Лучевая терапия Hypofractionated external beam radiotherapy
  5500 cGy/20 fractions delivered 5 days per week over 4 weeks
• Лучевая терапия High dose rate brachytherapy
  A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance
• Лучевая терапия Permanent seed implant
  Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance
• Лучевая терапия Stereotactic body radiotherapy
  External radiation using SABR technology delivers 36.25 Gy to the prostate in 5 fractions given either once weekly for 5 weeks or every second day over 2 weeks.

Первичные конечные точки

• Urinary symptoms [Срок оценки: Baseline to 2 years]

Вторичные конечные точки (9)

• Expanded Prostate Cancer Index (EPIC) urinary domain [Срок оценки: Baseline to 2 years]
• EPIC bowel domain [Срок оценки: Baseline to 2 years]
• EPIC sexual domain [Срок оценки: Baseline to 2 years]
• Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir [Срок оценки: Baseline to 3 years]
• Distant metastatic failure [Срок оценки: Baseline to 3 years]
• Nodal progression [Срок оценки: Baseline to 3 years]
• Overall survival [Срок оценки: 3 years]
• Cause specific survival [Срок оценки: Within 3 years of treatment]
• Cost effectiveness [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Signed study specific informed consent
• European Cooperative Oncology Group performance status 0 to 2
• Histologically confirmed adenocarcinoma of the prostate
• Any Tumor stage, any T, any N, M1
• No prior therapy for prostate cancer apart from androgen deprivation
• Planned for long-term androgen deprivation therapy (greater than 9 months in duration)
• Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study
• For brachytherapy arms, patient must be technically suitable for brachytherapy according to investigator, in terms of bladder function and prostate size.

Критерии исключения

• High metastatic burden defined as 5 or more bone metastases or visceral metastases
• Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
• For Brachytherapy Arms =: Any prior Transurethral resection of prostate

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

Канада · 4 центра

• British Columbia Cancer Agency Center for the Southern Interior — Kelowna
• Fraser Valley Cancer Center — Surrey
• Vancouver Cancer Center — Vancouver
• Vancouver Island Cancer Center — Victoria

Идентификаторы

NCT: NCT04610372 · H20-01207

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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