Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experience Grade 3 or Higher Acute Toxicities
研究概览
简要总结
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 proven adenocarcinoma of the prostate.
- •Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
- •Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
- •Gleason score ≤ 7
- •No evidence of distant metastasis
- •Informed consent signed in accordance with institutional protocol
- •Pretreatment evaluations must be completed as specified in Section 7.
- •ECOG performance status 0-1
- •No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
- •No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
- •Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
- •No previous or concurrent cytotoxic chemotherapy
- •No radical surgery or cryosurgery for prostate cancer
- •The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
- •The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
- •No current use of anticoagulation therapy, other than aspirin.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Experience Grade 3 or Higher Acute Toxicities
时间窗: 90 days post radiation treatment
To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants experience acute toxicities grade 3 or higher.
Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up
时间窗: from 90 days post XRT through last follow-up visit (up to 3 years)
To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate
次要结局
- International Index of Erectile Function (IIEF) Score at Baseline and 3 Years(Baseline and 3 years)
- Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years(Baseline and 3 years)
- Biochemical Progression-free Survival Based on PSA Surveillance(up to 15 years from enrollment)
- Fox Chase Bowel Survey at Baseline and 3 Years(Baseline and 3 years)
- Fox Chase Bladder Survey at Baseline and 3 Years(Baseline and 3 years)