ISRCTN11089334进行中（未招募）3 期
Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 主要终点
- Metastatic free survival (defined as time from randomisation to progression of the treated node(s), new nodal, bone or visceral metastatic disease, or death due to PCa) measured using patient records
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Age >=18 years, male
- •Histological diagnosis of prostate adenocarcinoma
- •Previous primary prostate cancer (PCa) treatment (radical prostatectomy [RP], primary/ post-operative radiotherapy [RT] or brachytherapy without previous pelvic nodal RT)
- •Maximum of three PET-CT defined macroscopically-involved pelvic lymph nodes (upper limit of the pelvis is defined as the aortic bifurcation) within 6 months prior to randomisation
- •World Health Organisation (WHO) performance status 0-
- •Willing to be randomised to stereotactic body radiotherapy (SBRT), ENI-5 or ENI-
- •Patients must be able to provide study-specific written informed consent
- •Prepared to participate in follow-up by telephone or in-person
排除标准
- •Previous pelvic nodal radiotherapy
- •Contraindications to SBRT or ENI (e.g. inflammatory bowel disease)
- •Contraindications to ADT
- •Local recurrence in the prostate gland
- •Para-aortic nodal metastases (above the aortic bifurcation)
- •Meso-rectal nodal metastases
- •Bone or visceral metastases
- •Severe late toxicity relating to primary/post-operative RT
- •Other active malignancy (except non-melanoma skin cancer or other malignancy with a documented disease-free survival for a minimum of 3 years before randomisation)
- •Castrate-resistant disease
结局指标
主要结局
Metastatic free survival (defined as time from randomisation to progression of the treated node(s), new nodal, bone or visceral metastatic disease, or death due to PCa) measured using patient records
次要结局
- PROM-assessed late bowel toxicity at 3 years, measured using the Expanded Prostate Cancer Index Composite 26-item questionnaire (EPIC-26) bowel function sub-domain.
研究者
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