Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy Using SBRT for Prostate Cancer to Reduce Treatment Toxicity

Обзор

This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan. This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 \& IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.

Вмешательства

• Лучевая терапия Image-guided Radiotherapy
  * Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas with SBRT, 25Gy in 5 fractions to prostate bed +/- pelvic lymph nodes delivered every other day with a boost to PSMA avid disease of 35 Gy in 5 fraction * Treatment of pelvic lymph nodes and androgen deprivation therapy for 0-24 months at clinician discretion

Первичные конечные точки

• Radiation-induced Acute Grade ≥2 Toxicity [Срок оценки: Baseline to 5-year follow up]

Вторичные конечные точки (4)

• Acute and Late GI and GU toxicities [Срок оценки: Estimated at 6 months and 2 years following treatment]
• Local Recurrence [Срок оценки: Estimated at 2 years and 5 years following treatment]
• Biochemical Disease Free Survival [Срок оценки: Estimated at 2 years and 5 years following treatment]
• Patient-reported quality-of-life assessed by EPIC-26 and IPSS [Срок оценки: Baseline to 5-year follow-up]

Критерии участия

Критерии включения

• Age ≥ 18 years old.
• Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
• Radical prostatectomy > 6 months prior to commencing SBRT.
• Biochemical relapse with local and/or regional recurrence proven with PSMA PET
• ECOG 0-1.

Критерии исключения

• Presence of para-aortic lymph nodes or distant metastasis.
• Chronic pelvic inflammatory disease.
• Contraindication for radiation treatment.
• Previous radiation treatment within the pelvis.

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

Канада · 1 центр

• University Health Network - Princess Margaret Cancer Center — Toronto

Идентификаторы

NCT: NCT07515651 · 25-6057

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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