A Phase I/Ib, Single Arm Study of Two Fraction Stereotactic Body Radiation Therapy (SBRT) With Dominant Lesion Simultaneous Integrated Boost (SIB) for the Treatment of Low to Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
研究概览
简要总结
Phase I/Ib, single arm trial of Two-Fraction Stereotactic Body Radiation Therapy (SBRT) with an MRI directed, dominant intraprostatic lesion (DIL), simultaneous integrated boost (SIB) based on genomic classification in the treatment of localized prostate cancer. The primary purpose of this study is to determine the feasibility and safety of two fraction SBRT in patients with localized prostate cancer.
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
- •Patient age greater than or equal 18
- •Localized adenocarcinoma of the prostate
- •Biopsy-proven diagnosis of prostate adenocarcinoma
- •Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease
- •TX-T2c-8th addition staging
- •PSA<20 ng/ml
- •Grade group 3 or less
- •Proper rectal space replacement required as determined by the treating radiation oncologist
- •Prostate size less than 60cc defined at time of simulation based on MRI
- •Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion
- •-- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized
- •Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist
- •Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills
- •Ability to give informed consent
排除标准
- •High risk disease
- •Pelvic lymph node involvement
- •Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist
- •Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion
- •Prior radiation to the pelvis
- •Prior malignancies within the last 5 years
- •Inability to meet pre-specified 2 fraction DVH constraints
- •Prostate size > 60cc as measures at treatment planning MRI
- •Active significant inflammatory bowel disease (IBD) or rheumatological disease
- •Prior prostate surgeries
- •Previous uro lift
- •Transurethral resection of the prostate (TURP) within 6 months of SBRT
- •"Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (>50 overall summary score for each domain)
- •Men of reproductive potential may not participate unless they agree to use an effective contraceptive method
研究组 & 干预措施
Men with low to intermediate risk prostate cancer
Once a patient is deemed eligible, they will be scheduled for treatment with SBRT, which should be completed within 14 days of screening. Follow up will occur 30 days post radiation and every 4 months, post- radiation for the first 2 years. After the first 2 years of follow up, visits will occur every 6 months until year 5.
干预措施: Two-Fraction Stereotactic Body Radiation Therapy (SBRT) (Radiation)
结局指标
主要结局
Number of Grade 2 or Higher Toxicities per CTCAE version 5.0
时间窗: Up to year 5 Post-Treatment
Number of toxicities determined to be Grade 2 or higher based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
- Metastasis-Free Survival (MFS)(Up to Year 5 Post-Treatment)
- Overall Survival (OS)(Up to Year 5 Post-Treatment)
- Disease-Free Survival (DFS)(Up to Year 5 Post-Treatment)
- Nadir Prostate-Specific Antigen (nPSA) Levels(Up to Year 5 Post-Treatment)
- Change in Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaire Score(Baseline, Year 5 Post-Treatment)
- Incidence of Phoenix Definition Biomechanical Failure (BCF)(Up to Year 5 Post-Treatment)