"Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer" "Hypofraktionierte Protonentherapie Mit Spot-Scanning-Technik Bei Prostatakarzinom Mit Niedrigem Oder Mittlerem Risiko"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- freedom from biochemical failure
研究概览
简要总结
This prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.
详细描述
The purpose of this study is to assess the effectiveness and safety of spot-scanning based hypofractionated proton radiotherapy for the treatment of intermediate and low risk prostate cancer. The treatment effectiveness is defined as freedom from biochemical failure. Treatment safety will be documented with acute and late morbidity assessments. Dose volume relationships for late side effects in organs at risk surrounding the prostate will be calculated from the dose volume histogram parameters assessed during treatment planning. Patient assessed Quality of life data including sexual function will be collected to increase our understanding how the reduction of normal tissue irradiation with proton therapy with subsequent decrease in functional impairments will overall affect the patient's life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Clinical stage T1-T2b
- •Prostate specific antigen (PSA) ≤ 20 ng/mL
- •Gleason Score ≤ 7
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- •Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or MRI scan)
- •Any patient with lymph nodes > 1.0 cm maximum diameter requires further studies to address eligibility. Positron emission tomography (PET)-CT is recommended for lymph nodes > 1.0 cm. Positive PET-CT indicates malignant involvement. Hence, the patient will be staged as "high-risk" and therefore declared ineligible for study participation. Negative PET-CT in lymph nodes 1.0-1,5 cm indicates non-involvement and thus eligibility. Negative PET-CT in lymph nodes > 1.5 cm is equivocal and requires additional work-up, preferably by biopsy.
- •Patients must be 18 years of age or older. There is no upper age limit.
- •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 to assess Quality of Life.
- •Previously initiated Androgen Deprivation Therapy (ADT) is acceptable.
- •Patients with history of chronic bowel diseases may be included.
- •Patients with previous Transurethral Resection of the Prostate (TURP) performed for urinary retention may be included.
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.
- •Concurrent cytotoxic chemotherapy for prostate cancer.
- •Evidence of distant metastases.
- •Regional lymph node involvement.
- •International Prostate Symptom Score (IPSS) > 20
- •Hip prosthesis
- •Second invasive malignancy (except of basal cell and squamous cell carcinoma of the skin in situ) if not controlled within last two years.
研究组 & 干预措施
Proton Therapy of Prostate Cancer
Patients with low and intermediate risk are included. The following interventions are performed:
- 'Expanded Prostate Cancer Index Composite' (EPIC) questionnaire
- kV x-ray images
- Conebeam CT
干预措施: Conebeam CT (Radiation)
Proton Therapy of Prostate Cancer
Patients with low and intermediate risk are included. The following interventions are performed:
- 'Expanded Prostate Cancer Index Composite' (EPIC) questionnaire
- kV x-ray images
- Conebeam CT
干预措施: EPIC questionnaire (Other)
Proton Therapy of Prostate Cancer
Patients with low and intermediate risk are included. The following interventions are performed:
- 'Expanded Prostate Cancer Index Composite' (EPIC) questionnaire
- kV x-ray images
- Conebeam CT
干预措施: kV x-ray images (Radiation)
结局指标
主要结局
freedom from biochemical failure
时间窗: 5 years
Freedom from biochemical failure outcomes (FFBF) following spot-scanning based, moderately hypofractionated proton therapy will be compared with results of published studies using either similar or standard dose fractionation treatment regimen and using either photon or proton therapy. Determination of e.g., PSA, IPSS, Adverse Events
次要结局
- Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy.(daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment))
- Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy.(daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment))
- Determine overall survival at 5 years.(5 years)
- Determination of the intra- and inter- mobility of prostate, seminal vesicles and rectum in order to further define and refine planning target volume parameters for future applications.(daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment))
- Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years(Months 24(±2))
- Assessment of the quality of life and sexual function following proton therapy.(Baseline, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4))
- Correlation of adverse events (toxicity), quality of life (QoL) and sexual function with dosevolume histogram parameters adjusted according to actual dose delivered.(Dose volume histogram parameters: Pre-Treatment, Toxicity: Weekly during proton therapy, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4), Quality of life: Pre-Treatment, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4))
- Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment(weekly through treatment completion, Months 3(±1))
- Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years(Months 60(±4))
- Determine disease specific survival at 5 years.(5 years)