NCT02040610招募中不适用
A Phase II Study of Hypofractionated Image Guided Proton Therapy for Low and Intermediate Risk Prostate Cancer
Provision Center for Proton Therapy4 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 235
- 试验地点
- 4
- 主要终点
- Time to biochemical failure
研究概览
简要总结
This study is being proposed to evaluate the use of moderate hypofractionated proton therapy in low and intermediate risk prostate cancer patients. Quality of life outcomes as well as gastrointestinal and genitourinary early and late toxicities will be analyzed and compared to conventional proton therapy regimens. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
详细描述
Patients will receive: 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Pathological (histologically) proven diagnosis of prostatic adenocarcinoma within 365 days (1 year) prior to study registration.
- •History and physical exam with digital rectal exam of the prostate to establish clinical staging
- •Clinical stage T1-T2c (AJCC 7th edition) within 90 days of registration.
- •Prostate specific antigen (PSA) < 20 ng/mL within 90 days prior to registration.
- •Gleason Score <
- •Eastern Cooperative Oncology Group(ECOG) Performance status 0-
- •Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or MRI scan).
- •Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are ≤ 1.5 cm in diameter; any node larger than this on imaging will require negative biopsy for eligibility, unless the node is know to be enlarged from prior scans and considered stable, per discretion of the treating physician.
- •Patients must be 18 years of age or older.
- •Patient must be able to provide study-specific informed consent prior to study entry.
- •Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire.
- •No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
- •Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility.
- •Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
- •Patient is able to start proton therapy or neo-adjuvant hormonal therapy, when recommended, within 12 weeks of registration.
- •No prior radiotherapy to the pelvic area.
- •No prior prostate cancer therapy such as: prostatectomy, cryotherapy, chemotherapy or hyperthermia.
- •Platelets ≥ 100,000 cells/mm3, Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3, Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
- •Obs.: Patients with high risk factors, such as T3, Gleason 8-10 or PSA > 20ng/mL who are not considered candidates for pelvic lymph node radiation treatment are still considered eligible for this study.
排除标准
- •• Prior radiotherapy to the pelvic area.
- •Prior prostate cancer therapy such as: prostatectomy, cryotherapy, or hyperthermia.
- •Prior systemic therapy (chemotherapy) for prostate cancer.
- •Evidence of distant metastases.
- •Regional lymph node involvement.
- •Previous or concurrent cytotoxic chemotherapy for prostate cancer.
- •Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition. Note however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immune-compromised patients.
研究组 & 干预措施
Low Risk Prostate Cancer
Active Comparator
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
干预措施: Hypofractionated Proton Therapy (Radiation)
Intermediate Risk Prostate Cancer
Active Comparator
Hypofractionated Proton Therapy 62 Gy (RBE) in 20 fractions of 3.1 Gy (RBE) over 4 weeks
干预措施: Hypofractionated Proton Therapy (Radiation)
结局指标
主要结局
Time to biochemical failure
时间窗: 5 years
To determine the freedom from biochemical failure survival outcomes (FFBF) and compare to historical FFBF results achieved following standard fractionation proton therapy
次要结局
- Toxicity Assessment(2 years & 5 years)
- Analyze Quality of Life(2 years & 5 years)
研究者
研究点 (4)
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