Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Rate of late grade 2+ genitourinary (GU) toxicity
研究概览
简要总结
This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate late grade 2+ genitourinary (GU) toxicity.
SECONDARY OBJECTIVE:
I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life.
OUTLINE:
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
- •Age: above 18 years
- •Participants must be histologically proven, adenocarcinoma prostate
- •Localized to the prostate without positive pelvic lymph node involvement
- •No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan
- •High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) > 20 ng/mL
- •Ability to receive long term hormone therapy
- •Karnofsky performance score (KPS) > 70
- •No prior history of therapeutic irradiation to pelvis
- •Patient willing and reliable for follow-up and quality of life (QOL)
- •English speaking/reading
排除标准
- •Evidence of distant or pelvic metastasis at any time since presentation
- •Life expectancy < 2 years
- •Previous radiation therapy (RT) to prostate or prostatectomy
- •A previous trans-urethral resection of the prostate (TURP)
- •Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT
- •Patients with known obstructive symptoms with stricture
- •Any contraindication to radiotherapy such as inflammatory bowel disease
研究组 & 干预措施
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: MRI-guided Intensity-Modulated Radiation Therapy (Procedure)
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: Antiandrogen Therapy (Drug)
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: PSMA PET Scan (Procedure)
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: Computed Tomography (Procedure)
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: Bone Scan (Procedure)
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Treatment (MRI-guided IMRT, ADT)
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Rate of late grade 2+ genitourinary (GU) toxicity
时间窗: At 1 year
Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.
次要结局
- Quality of life measurement(every 6 months beginning at year 2, assessed up to 4 years)
- Incidence of late GI toxicity(every 6 months beginning at year 2, assessed up to 4 years)
- Incidence of acute GU and gastrointestinal (GI) toxicity(every 6 months beginning at year 2, assessed up to 4 years)
- Prostate cancer specific survival(every 6 months beginning at year 2, assessed up to 4 years)
- Biochemical failure(every 6 months beginning at year 2, assessed up to 4 years)
- Overall survival(every 6 months beginning at year 2, assessed up to 4 years)
- Prostate cancer specific survival(At treatment completion, up to 10 days)
- Prostate cancer specific survival(every 3 months after treatment until 1 year)
- Incidence of acute GU and gastrointestinal (GI) toxicity(At baseline)
- Incidence of acute GU and gastrointestinal (GI) toxicity(At treatment completion, up to 10 days)
- Incidence of acute GU and gastrointestinal (GI) toxicity(every 3 months after treatment until 1 year)
- Incidence of late GI toxicity(At baseline)
- Incidence of late GI toxicity(At treatment completion, up to 10 days)
- Incidence of late GI toxicity(every 3 months after treatment until 1 year)
- Overall survival(At baseline)
- Overall survival(At treatment completion, up to 10 days)
- Overall survival(every 3 months after treatment until 1 year)
- Prostate cancer specific survival(At baseline)
- Biochemical failure(At baseline)
- Biochemical failure(At treatment completion, up to 10 days)
- Biochemical failure(every 3 months after treatment until 1 year)
- Quality of life measurement(At baseline)
- Quality of life measurement(At treatment completion, up to 10 days)
- Quality of life measurement(every 3 months after treatment until 1 year)