Hypo-Combi Trial: Combined Hypofractionated External Beam Radiation Therapy (EBRT) Plus Interstitial High-Dose-Rate Brachytherapy (HDR-BT) Boost for Intermediate/High Risk Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity
研究概览
简要总结
Hypo-Combi Trial: A Prospective Phase I/II Study of Combined Hypofractionated External Beam Radiation Therapy (EBRT) plus Interstitial High-Dose-Rate Brachytherapy (HDR-BT) for Intermediate/High Risk Prostate Cancer
详细描述
The Phase I/II trial will prospectively assess the acute, early late and late gastrointestinal (GI), genitourinary (GU) and sexual toxicity of combined hypofractionated external beam radiation therapy (EBRT) plus high dose-rate brachytherapy (HDR-BT) schedule (total dose of EBRT 36 Gy/ in 12 fractions of 3 Gy plus HDR-BT with a total physical dose of 14 Gy in a single fraction) for patients with unfavourable intermediate/high risk (based on NCCN stratification guidelines) organ-confined prostate cancer, not requiring pelvic irradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The patient must consent to be in the study and must have signed an approved consent form
- •Age > 18 years old.
- •Life expectancy of at least five years, excluding his diagnosis of prostate cancer.
- •Histopathologically proven primary adenocarcinoma of the prostate
- •The patient must be registered within 180 days following the histopathological confirmation of the malignancy
- •Prostate volume < 80ml
- •International Prostate Symptom Score (IPSS) < 18
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Patients with a history of non-prostate malignancies are eligible if they have been disease-free for 5 or more years prior to enrolment, are deemed by their physician to be at low risk for recurrence and they did not need pelvic radiotherapy as part of their treatment. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
排除标准
- •Histopathological confirmation or suspicion in conventional or molecular imaging of regional or distant metastases
- •Prior pelvic radiotherapy
- •Known autoimmune disorders (e.g. inflammatory bowel disease, lupus, scleroderma)
- •Prior TURP
- •MRI non compatible metal implants
- •Pre-existing fistulae
- •Contraindication for general and spinal anaesthesia
- •Inability to be placed in lithotomy position
- •Any treatment with radiation therapy, chemotherapy, immunotherapy, biotherapy and/or hormonal therapy for the currently diagnosed prostate cancer prior to registration.
- •History of non-prostate malignancy, apart from patients that have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence.
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
研究组 & 干预措施
Hypofractionated EBRT plus HDR-BT boost
Primarily hypofractionated EBRT consisting of 12 x 3 Gy/fraction, TD 36 Gy will be administered. Followed by HDR-BT boost of the prostate, TD 14 Gy.
干预措施: External beam radiation therapy, High-dose-rate brachytherapy (Radiation)
Hypofractionated EBRT plus HDR-BT boost
Primarily hypofractionated EBRT consisting of 12 x 3 Gy/fraction, TD 36 Gy will be administered. Followed by HDR-BT boost of the prostate, TD 14 Gy.
干预措施: Goserelin 10.8 mg (Drug)
结局指标
主要结局
Rate of acute and early late genitourinary, gastrointestinal and sexual toxicity
时间窗: up to 2 years
RTOG/EORTC questionnaires will be collected and evaluated for GU/GI toxicity. International Prostate Symptom Score will be assessed for lower urinary tract symptomatology and IIEF-5 for erectile function.
次要结局
- Rate of prostate cancer-specific survival(2 years, 5 years)
- Rate of overall survival(2 years, 5 years)
- 18F-PSMA PET/CT Vs conventional imaging for identification of pelvic nodal or distant secondaries(2 years)
- Rate of biochemical control(2 years, 5 years)
- Rate of distant metastasis-free survival(2 years, 5 years)
- Rate of treatment-related symptoms on Quality of Life assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire(2 years, 5 years)