Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
Background:
Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).
Objective:
To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation.
Eligibility:
Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease.
Design:
Participants will be screened with blood tests, physical exam, and medical history. They may also have:
Magnetic resonance imaging (MRI) scan of the prostate.
Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an injection of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) for the PET scan. They will lie very still on their back on the scanner table.
Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation.
About 2 weeks later, participants will have a radiation treatment planning CT scan.
Participants will answer questions about their urine function, bowel function, erectile function, and mood.
Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.
Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires.
Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated.
Participants will continue to have routine visits until two years after treatment is completed....
详细描述
Background:
- Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to the side effects of available treatments such as surgery and cryoablation.
- Re-irradiation with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer disease control with tolerable side effects.
- Using image guidance to allow highly conformal focal re-irradiation may potentially increase the efficacy of re-irradiation.
Objectives:
-Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence of prostate cancer after prior radiotherapy.
Eligibility:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1, Level 1, Arm 1: Tumor Irradiation
Arm 1: Tumor irradiation.
Cohort 1, Level 1, Arm 1 - 40 gray (Gy) to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.
External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.
干预措施: 18F-DCFPyL (Drug)
Cohort 1, Level 1, Arm 1: Tumor Irradiation
Arm 1: Tumor irradiation.
Cohort 1, Level 1, Arm 1 - 40 gray (Gy) to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.
External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.
干预措施: Tumor Irradiation (Radiation)
Cohort 1, Level 2, Arm 1 - Tumor Irradiation
Arm 1: Tumor irradiation.
Cohort 1, Level 2, Arm 1 - 42.5 gray (Gy) to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.
干预措施: 18F-DCFPyL (Drug)
Cohort 1, Level 2, Arm 1 - Tumor Irradiation
Arm 1: Tumor irradiation.
Cohort 1, Level 2, Arm 1 - 42.5 gray (Gy) to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.
干预措施: Tumor Irradiation (Radiation)
Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation
Arm 2: Prostate and tumor irradiation
Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.
干预措施: 18F-DCFPyL (Drug)
Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation
Arm 2: Prostate and tumor irradiation
Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.
干预措施: Prostate + tumor irradiation (Radiation)
Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation
Arm 2: Prostate and tumor irradiation
Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.
干预措施: Tumor Irradiation (Radiation)
Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation
Arm 2: Prostate and tumor irradiation
Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.
干预措施: 18F-DCFPyL (Drug)
Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation
Arm 2: Prostate and tumor irradiation
Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.
干预措施: Prostate + tumor irradiation (Radiation)
Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation
Arm 2: Prostate and tumor irradiation
Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment.
干预措施: Tumor Irradiation (Radiation)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 3 weeks post-treatment
The MTD of image-guided, focally dose escalated prostate stereotactic body radiation therapy (SBRT) in participants with a local recurrence of prostate cancer after prior radiotherapy. The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during treatment and up to 3 weeks following completion of treatment, and the dose below that at which at least 2 (of .6) participants have DLT as a result of treatment. A DLT is a Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days, other Grade 3 in-field toxicities attributable to Stereotactic body radiation therapy (SBRT) that do not resolve to a Grade 2 or less within 4 days, and delays of more than one week in completing radiation treatment due to toxicity.
次要结局
- Sensitivity of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (18F-DCFPyL) Imaging as Compared to Biopsy in Detecting Locally Recurrent Prostate Cancer(6 months after radiation)
- Specificity of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (18F-DCFPyL) Imaging as Compared to Biopsy in Detecting Locally Recurrent Prostate Cancer(6 months after radiation)
- Changes of Sexual Health Inventory for Men (SHIM) Quality of Life (QOL) Scores During and After Treatment(Baseline compared to 24 months after treatment)
- Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment(Baseline compared to 24 months after treatment)
- Changes of Expanded Prostate Cancer Index Composite (EPIC-26) Quality of Life (QOL) Scores During and After Treatment(Baseline compared to 24 months after treatment)
- Biochemical Progression Free Survival (bPFS)(1 and 2 years after treatment)
- Dose Limiting Toxicities (DLT)(3 weeks after end of treatment)
研究者
Deborah Citrin, M.D.
Principal Investigator
National Cancer Institute (NCI)