A Phase I Trial of Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions
研究概览
简要总结
Background:
Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective. It is usually given in short doses almost every day for 6 or 7 weeks. Researchers want to see if a shorter schedule can be as effective. They want to see if that causes the same or fewer side effects. Usually, radiation is used to treat the entire area where the prostate was before surgery. In some patients, an area of tumor can be seen on scans. Researchers are also trying to see if they can give less dose to the area usually treated with radiation if the full dose is given to the tumor seen on scans.
Objective:
To find the shortest radiation schedule that people can tolerate without strong side effects.
Eligibility:
People at least 18 years old who have had a prostatectomy and will get radiation.
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood and urine tests
- Scan that uses a small amount of radiation to make a picture of the body
- Scan that uses a magnetic field to make an image of the body
- Participants will provide documents that confirm their diagnosis.
- Participants may have a scan of the abdomen and pelvis.
Before they start treatment, participants will have another physical exam and blood tests.
Participants will get radiation each day Monday through Friday. Treatment may last 2, 3, or 4 weeks.
Participants may provide a tissue sample from a previous procedure for research.
Participants will answer questions about their general well-being and function.
About 4-5 weeks after they finish radiation treatment, participants will have a follow-up visit. They will be examined and give a blood sample. They will have 6 follow-up visits for the next 2 years.
详细描述
BACKGROUND:
Prostate cancer that recurs after prostatectomy (rising prostate-specific antigen (PSA) with no evidence of metastatic disease is often treated with radiation to the entire prostate bed to a dose of 66-72 Gray (Gy) over 6-7 weeks. This treatment can provide PSA control in approximately 75% of patients but may have associated genitourinary and gastrointestinal toxicity due to irradiation of the rectum, small bowel, and bladder. Imaging of prostate cancer has improved to the extent that recurrent disease is often identified in the prostate bed or in other pelvic sites. The current standard is to irradiate the entire prostate bed to the total dose. This trial will test the tolerability of accelerated treatment designed to yield a similar rate of late toxicity. In addition, in patients with visible tumor, it will test the feasibility of delivering a lower dose to the prostate bed and an integrated boost (simultaneous) to the visible tumor to allow a higher dose to visible tumor than can be delivered with standard approaches.
OBJECTIVE:
- Define the maximum tolerated dose (MTD) hypofractionation of image guided, focally dose escalated post-prostatectomy radiation.
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
- •INCLUSION CRITERIA:
- •Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Indications for post-prostatectomy radiation exist:
- •Disease progression (detectable prostate-specific antigen (PSA) on two measurements obtained at least one month apart) or
- •indications for adjuvant radiation exist (if undetectable PSA): pathologic T3, T4, N+ disease or positive margins (within 1 year of prostatectomy).
- •Age greater than or equal to 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 60)
- •Ability of subject to understand and the willingness to sign a written informed consent document.
- •Radiation is teratogenic; thus, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and up to 120 days after the last radiation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
- •Human immunodeficiency virus (HIV) positive patients are included if CD4+ (cytotoxic T cells) T-cell count > 200 cells/uL; on stable antiretroviral therapy for > 1 year with HIV viral load <200 copies/mL, and no history of opportunistic infections in > 1 year.
排除标准
- •Patients who are receiving any other investigational agents concurrently.
- •Documented metastases of prostate cancer outside of the pelvis (pelvic lymph nodes are allowed only if within the prostate bed region).
- •History of radiation that would overlap with the intended treatment to the prostate bed.
- •Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (Ataxia Telangiectasia or Fanconi's Anemia)
- •Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results.
- •Medically indicated use of known radiosensitizing drugs (such as protease inhibitors)
研究组 & 干预措施
Arm 1/Prostate Bed with Integrated Boost
Prostate bed with integrated boost.
干预措施: mpMRI (Diagnostic Test)
Arm 1/Prostate Bed with Integrated Boost
Prostate bed with integrated boost.
干预措施: Prostate bed with integrated boost (Radiation)
Arm 1/Prostate Bed with Integrated Boost
Prostate bed with integrated boost.
干预措施: 18F-NaF PET Imaging (Diagnostic Test)
Arm 1/Prostate Bed with Integrated Boost
Prostate bed with integrated boost.
干预措施: CT (Diagnostic Test)
Arm 2/Prostate Bed Irradiation Only
Prostate bed irradiation only.
干预措施: 18F-NaF PET Imaging (Diagnostic Test)
Arm 2/Prostate Bed Irradiation Only
Prostate bed irradiation only.
干预措施: CT (Diagnostic Test)
Arm 2/Prostate Bed Irradiation Only
Prostate bed irradiation only.
干预措施: mpMRI (Diagnostic Test)
Arm 2/Prostate Bed Irradiation Only
Prostate bed irradiation only.
干预措施: ADT (Drug)
Arm 1/Prostate Bed with Integrated Boost
Prostate bed with integrated boost.
干预措施: ADT (Drug)
Arm 1/Prostate Bed with Integrated Boost
Prostate bed with integrated boost.
干预措施: Whole Body Bone Scan (Diagnostic Test)
Arm 2/Prostate Bed Irradiation Only
Prostate bed irradiation only.
干预措施: Prostate bed irradiation only (Radiation)
Arm 2/Prostate Bed Irradiation Only
Prostate bed irradiation only.
干预措施: Whole Body Bone Scan (Diagnostic Test)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Fractions
时间窗: 3 weeks after radiation
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
Maximum Tolerated Dose (MTD) of Radiation Dose to Prostate Bed and Dose to Tumor Reported in Gray (Gy)
时间窗: 3 weeks after radiation
Maximum tolerated dose (MTD) of image guided hypofractionated, focally dose escalated post-prostatectomy radiation is defined as the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT period, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of treatment. A DLT is defined as any of the following: Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to radiation that does not resolve to Grade 2 or less within 4 days with appropriate medical management. And delays of more than one week in completing radiation treatment due to toxicity.
次要结局
- Grade 2-5 Serious and/or Non-serious Adverse Events Unlikely, Probably, Possibly and Definitely Attributable to Research(3 weeks after radiation)
- American Urologic Association Symptom Index Score (AUA-SI)(2 years after treatment)
- Decision Regret Scale (DRS)(2 years after treatment)
- Proportion of Participants That Have Improvement in Quality of Life After Treatment(1 and 2 years after treatment)
- Sexual Health Inventory for Men (SHIM)(2 years after treatment)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Psychosocial Impact Positive Short Form (SF) 4a(2 years after treatment)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety Short Form (SF) 4a:(2 years after treatment)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Short Form (SF) 4a:(2 years after treatment)
- Biochemical Progression Free Survival (bPFS)(1 and 2 years after treatment)
- Changes in Erectile Dysfunction QOL Scores During and After Treatment Measured by the Sexual Health Inventory for Men (SHIM)(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)
研究者
Deborah Citrin, M.D.
Investigator
National Cancer Institute (NCI)