Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer

Официальное название

Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial

Обзор

This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).

Подробное описание

The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.

Вмешательства

• Лучевая терапия Stereotactic Body Radiation Therapy (SBRT)
  SBRT will be delivered as per institutional standard.
• Другое Systemic therapy
  Participants will receive Systemic Therapy. Participants in Arm 1 - SOC may change the Systemic Therapy throughout treatment. Participants in Arm 2 - Experimental will remain on the same Systemic Therapy throughout treatment.

Первичные конечные точки

• Study Feasibility [Срок оценки: Within 18 months of study activation.]
• Change in Prostate-Specific Antigen (PSA) [Срок оценки: Enrollment to 12 months post-enrollment.]

Вторичные конечные точки (6)

• Radiographic Local Control of Oligopressive Lesions [Срок оценки: Enrollment to 12 months-post enrollment.]
• Radiographic Distant Control of Oligopressive Lesions [Срок оценки: Enrollment to 12-months post-enrollment.]
• Progression Free Survival (PFS) [Срок оценки: Enrollment to 12-months post-enrollment.]
• Time to next Systemic Therapy [Срок оценки: Enrollment to 12-months post-enrollment.]
• Differences in Toxicity [Срок оценки: Enrollment to 12-months post-enrollment.]
• Differences in Quality of Life [Срок оценки: Enrollment to 12-months post-enrollment.]

Критерии участия

Критерии включения

• Age >18 years
• Able to provide informed consent
• Histologic diagnosis of prostate adenocarcinoma
• Castrate Resistance Prostate Cancer
• Radiographic evidence of <10 sites of extra-cranial OP metastatic lesions
• Receiving any line of ST for >3 months
• All sites of OP disease are amenable to and can be safely treated with SBRT
• ECOG performance status 0-3

Критерии исключения

• Evidence of spinal cord compression
• Contraindication to radiotherapy

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 · 1 центр

• Princess Margaret Cancer Center — Toronto

Идентификаторы

NCT: NCT06927635 · 24-5872

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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