Prospective Cohort Study for Identifying Factors Predicting Long-term Outcomes of Prostate Cancer Patients Who Received Ultrahypofractionated Proton Beam Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Biochemical recurrence-free survival
研究概览
简要总结
The goal of this prospective observational cohort study is to evaluate the long-term efficacy and safety of ultrahypofractionated proton beam therapy in patients with localized prostate cancer and to identify clinical and treatment-related factors associated with oncologic outcomes and treatment-related toxicity.
The main questions it aims to answer are:
What are the long-term biochemical recurrence-free survival, clinical progression-free survival, overall survival, and acute and late treatment-related toxicity outcomes following ultrahypofractionated proton beam therapy? Which clinical characteristics, treatment planning parameters, and patient-reported outcomes are predictive of long-term oncologic outcomes and treatment-related toxicity?
Participants will:
Receive protocol-based ultrahypofractionated proton beam therapy (35-40 Gy[RBE] in 5 fractions).
Undergo routine clinical evaluation, laboratory testing including prostate-specific antigen (PSA), and imaging studies according to the institutional follow-up schedule.
Complete patient-reported outcome questionnaires (EPIC-CP and Visual Analog Scale [VAS]) before treatment and during follow-up.
Be followed prospectively to assess biochemical recurrence, clinical progression, survival outcomes, and acute and late treatment-related toxicities.
详细描述
Localized prostate cancer can be effectively treated with external beam radiotherapy (EBRT). Ultrahypofractionated radiotherapy has become an established treatment option because of its favorable radiobiological characteristics, shorter treatment duration, and improved patient convenience. Owing to the low alpha/beta ratio of prostate cancer, delivery of larger doses per fraction may provide radiobiological advantages while maintaining excellent tumor control.
Proton beam therapy (PBT) offers unique dosimetric advantages over photon radiotherapy by reducing unnecessary radiation exposure to surrounding normal tissues through the Bragg peak effect. These characteristics may be particularly beneficial for ultrahypofractionated treatment, especially in patients with intermediate- or high-risk disease who require treatment of larger target volumes, including the seminal vesicles or pelvic lymph nodes. However, prospective data regarding the long-term efficacy, safety, patient-reported outcomes, and predictive factors associated with ultrahypofractionated proton beam therapy remain limited.
This is a prospective, single-center observational cohort study conducted at the National Cancer Center, Republic of Korea. Approximately 50 adult patients with histologically confirmed localized prostate adenocarcinoma who are scheduled to undergo definitive ultrahypofractionated proton beam therapy will be prospectively enrolled after providing written informed consent.
All participants will receive protocol-based ultrahypofractionated proton beam therapy consisting of 35-40 Gy(RBE) delivered in five fractions using image-guided proton therapy. Androgen deprivation therapy will be administered according to contemporary clinical guidelines and physician discretion when indicated.
The primary objective of this study is to evaluate the long-term efficacy and safety of ultrahypofractionated proton beam therapy for localized prostate cancer. Secondary objectives include evaluation of biochemical recurrence-free survival, clinical progression-free survival, overall survival, acute and late treatment-related toxicity, and patient-reported quality of life. In addition, the study will prospectively investigate clinical characteristics, treatment planning parameters, dosimetric variables, and patient-reported outcome measures to identify factors associated with oncologic outcomes and treatment-related toxicity.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed localized adenocarcinoma of the prostate.
- •No evidence of distant metastasis (M0).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Eligible to receive definitive image-guided ultrahypofractionated pencil beam scanning proton beam therapy according to the study protocol.
- •Ability to complete study questionnaires and comply with scheduled follow-up assessments.
- •Provision of written informed consent before study enrollment.
排除标准
- •Residual or recurrent prostate cancer following prior radical prostatectomy.
- •Previous pelvic radiotherapy.
- •Evidence of distant metastatic disease.
- •Active malignancy within the previous 1 year, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or completely resected T1N0M0 malignancies.
- •Uncontrolled psychiatric illness, severe traumatic brain injury, chronic alcohol or substance dependence, or other medical conditions that, in the investigator's judgment, would preclude safe participation or adequate follow-up.
- •Inability or unwillingness to provide written informed consent or comply with study procedures.
研究组 & 干预措施
ultrahypofractionated proton beam therapy
Participants receive definitive ultrahypofractionated proton beam therapy (35-40 Gy[RBE] in 5 fractions) for localized prostate adenocarcinoma using image-guided proton therapy. Participants are prospectively followed for oncologic outcomes, treatment-related toxicity, and patient-reported quality of life.
干预措施: Ultrahypofractionated Proton Beam Therapy (Radiation)
结局指标
主要结局
Biochemical recurrence-free survival
时间窗: Up to 5 years after completion of proton beam therapy
Biochemical recurrence is defined according to the Phoenix definition (PSA nadir + 2 ng/mL). Biochemical recurrence-free survival is measured from completion of proton beam therapy to biochemical recurrence or last follow-up.
次要结局
- Patient-reported quality of life(baseline, postRT 1 month, 4 months, 7 months and 1 year)
- Clinical recurrence-free survival(Up to 5 years after completion of proton beam therapy)
- Overall survival(From completion of proton beam therapy to 5 years after treatment)
- Treatment-related genitourinary toxicity(Up to 5 years after completion of proton beam therapy)
- Treatment-related gastrointestinal toxicity(Up to 5 years after completion of proton beam therapy)
研究者
Sung Uk Lee
Clinical staff
National Cancer Center, Korea