Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Proportion of participants with treatment-related adverse events
研究概览
简要总结
This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety of HDR monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart in patients with low and intermediate risk prostate cancer.
SECONDARY OBJECTIVES:
I. To describe the prostate specific antigen (PSA) kinetics associated with HDR brachytherapy monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart for low and intermediate risk prostate cancer.
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
- •Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- •National Comprehensive Cancer Network favorable intermediate risk stratification, defined as one or more intermediate risk factors such as cT2b - cT2c category, grade group 1 or 2, or PSA 10-20 ng/mL, and less than 50% of biopsy cores positive for carcinoma (i.e. for this trial, we will only include systematic biopsy cores, not targeted biopsy cores).
- •Age >=18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%).
- •Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- •Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- •Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Willingness and ability to complete International Prostate Symptom Score questionnaires.
排除标准
- •Any prior treatment for prostate cancer.
- •Prior history of pelvic malignancy.
- •Any prior androgen deprivation therapy.
- •Is currently receiving any other investigational agents.
- •Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
- •Contraindications to general anesthesia.
- •Contraindications to radiotherapy.
- •Prior history of pelvic radiotherapy.
- •Presence of lymph node or distant metastases.
- •Prior cryosurgery or cryotherapy to the prostate.
- •Prior transurethral resection of the prostate (TURP) or transurethral incision within the previous 6 months.
- •Estimated prostate volume >60 cubic centimeters as determined by transrectal ultrasound or magnetic resonance imaging.
- •IPSS score of 15 or higher prior to treatment.
研究组 & 干预措施
HDR brachytherapy
Participants will receive the same radiotherapy technique, methods, and delivery will as standard of care 3 hours apart instead of receiving the radiotherapy on separate days.
干预措施: High Dose Rate Monotherapy (Radiation)
结局指标
主要结局
Proportion of participants with treatment-related adverse events
时间窗: Up to 6 months
The proportion of participants with reported grade 3 or higher genitourinary (GU) or gastrointestinal (GI) toxicities, as graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.
次要结局
- Mean Change in International Prostate Symptom Score (IPSS) over time(Up to 6 months)
- Mean Prostate Specific Antigen (PSA) Nadir(Up to 6 months)
- Mean Time to PSA Nadir(Up to 6 months)