Phase I Feasibility Study of Accelerated Hypofractionated Whole Pelvic Radiotherapy for Patients With Intermediate-High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Toxicity
研究概览
简要总结
This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by NCCN risk criteria. Patients will have >15% risk of lymph node involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated if >30% acute grade 2 or >5% grade 3 or greater toxicity is observed as a result of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.
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
- •Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA >10, and/or Gleason score ≥ 7) who have a greater than 15% risk of lymph node involvement as determined by the Roach equation.
- •History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
- •Zubrod performance status 0-2
- •Age ≥18 years
- •Ability to understand a written informed consent document, and the willingness to sign it
排除标准
- •Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
- •Evidence of distant metastases
- •Regional lymph node involvement
- •Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
- •Previous pelvic irradiation, prostate brachytherapy
- •Previous or concurrent cytotoxic chemotherapy for prostate cancer
- •Patients with history of inflammatory bowel disease or major bowel surgery.
- •Prior transurethral resection of the prostate (TURP) procedure.
研究组 & 干预措施
Treatment
Step 1: Pelvic Lymph Node Irradiation
Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each
Step 2: Treat boost volume to prostate and seminal vesicles
Acceptable treatment modalities:
CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT
Permanent prostate implant (PPI):
108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR
干预措施: Helical TomoTherapy (HT) (Radiation)
Treatment
Step 1: Pelvic Lymph Node Irradiation
Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each
Step 2: Treat boost volume to prostate and seminal vesicles
Acceptable treatment modalities:
CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT
Permanent prostate implant (PPI):
108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR
干预措施: CyberKnife SBRT (Radiation)
Treatment
Step 1: Pelvic Lymph Node Irradiation
Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each
Step 2: Treat boost volume to prostate and seminal vesicles
Acceptable treatment modalities:
CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT
Permanent prostate implant (PPI):
108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR
干预措施: Permanent Prostate Implant (PPI) (Radiation)
Treatment
Step 1: Pelvic Lymph Node Irradiation
Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each
Step 2: Treat boost volume to prostate and seminal vesicles
Acceptable treatment modalities:
CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT
Permanent prostate implant (PPI):
108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR
干预措施: HDR brachytherapy (Radiation)
结局指标
主要结局
Toxicity
时间窗: 90 days post treatment
Acute G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4
次要结局
- Late Toxicity(From 90 days post treatment until 36 months from start of therapy)
- High-Related Quality of Life (HRQOL)(Baseline, week prior to RT, 6 weeks post treatment, and at least every 6 months for the first 2 years.)
- PSA Complete Response (PSA-CR)(120-127 days after initiation of therapy)
研究者
Albert J. Chang
Assistant Professor
University of California, San Francisco