NCT07300566尚未招募2 期
FOcal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost With ExternAl Beam Radiotherapy in LocalizeD Prostate Cancer: A Phase 2 Randomized Trial [FORWARD]
Joelle Helou2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2026年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire
研究概览
简要总结
This project aims to compare the changes in the urinary quality of life (QoL) following focal high dose-rate brachytherapy (HDR-BT) boost to stereotactic ablative radiotherapy (SABR), compared to standard whole gland HDR-BT boost, in the treatment of men diagnosed with intermediate- and high-risk prostate cancer, with have an identifiable DIL on mpMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate
- •Eastern Co-Operative Oncology Group (ECOG) 0-2
- •Intermediate and high-risk disease with localized unfavorable features:
- •defined as clinical stage tumor cT1 or cT2a, International Society of Urological Pathology (ISUP) grade group 2-4 in less than or equal to 50% of the cores, unilateral extracapsular extension (ECE), prostate specific antigen (PSA) less than or equal to 20 ng/mL
- •corresponding to an Identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System score (PI-RADs 3-5)
- •Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess prostate volume. Patients with a prostate volume between 60 and 80 cc can be included if the International Prostate Symptom Score (IPSS) is less than 15 and brachytherapy is deemed feasible by the treating physician.
排除标准
- •Contraindications to mpMRI
- •Documented nodal or distant metastases
- •Previous pelvic radiotherapy
- •Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU)
- •Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19
- •Connective tissue disease or inflammatory bowel disease
- •Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department
- •Patient is unable to lie flat long enough for the Radiation Therapy (RT) Simulation and Treatment
结局指标
主要结局
Changes in Urinary Quality of Life at 24 Months Measured by the Expanded Prostate Index Composite (EPIC-26) Questionnaire
时间窗: From enrollment to 24 months post radiation therapy
To compare the impact on urinary quality of life (QoL) between focal high dose-rate brachytherapy (HDR-BT) boost and standard whole gland HDR-BT boost to stereotactic ablative radiotherapy (SABR) as reported by the participant on the Expanded Prostate Index Composite (EPIC-26) questionnaire.
次要结局
- Acute Changes in Urinary, Bowel, and Sexual Quality of Life(Less than or equal to 6 months post radiation therapy)
- Long Term Changes in Bowel and Sexual Quality of Life Measured by Expanded Prostate Index Composite (EPIC-26) Questionnaire(From enrollment to 24 months post radiation therapy)
- Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0(From enrollment to 24 months post radiation therapy)
- Prostate Specific Antigen (PSA) at 4 years(4 years post radiation therapy)
- Biochemical Control Measure by Prostate Specific Antigen (PSA) Levels(Enrollment to 5 years post radiation therapy)
- Participant reported Symptoms Measured by the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)(From enrollment to 24 months post radiation therapy)
研究者
Joelle Helou
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
研究点 (2)
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