Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 186
- 试验地点
- 1
研究概览
简要总结
This phase 2/3 randomized trial evaluates whether dose escalation to the dominant intra-prostatic lesion (DIL) compared to whole gland dose escalation during prostate stereotactic body radiotherapy (SBRT) results in differences in genitourinary (GU) and gastrointestinal (GI) toxicities.
详细描述
This is a phase 2/3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
In both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI).
The primary objective is to evaluate chronic genitourinary (GU) and gastrointestinal (GI) toxicities grade 2 or higher from 6 months to 2 years post-treatment using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary objectives include evaluation of acute and chronic GU and GI toxicities using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains, as well as biochemical progression-free survival at 5 years.
Participants will be followed for up to 5 years after completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adults ≥19 years of age
- •Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered
- •Prostate gland volume <100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT)
- •PI-RADS 4 or 5 lesion seen on pre-treatment MRI
- •IPSS/AUA symptom score less than 16
排除标准
- •Prior treatment for prostate cancer
- •Prior solid cancer diagnosis within the last 5 years
- •Any history of anal or rectal cancer
- •Any history of invasive carcinoma of the bladder
- •History of prior circumferential resection of the rectum (such as LAR or APR)
研究组 & 干预措施
Arm A: boost to prostate alone
Participants assigned to Arm A will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4000 cGy to the clinical target volume (CTV), consisting of the prostate alone without a margin. Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).
干预措施: Prostate stereotactic body radiotherapy with whole gland boost (Radiation)
Arm B: boost to dominant intra-prostatic lesion (DIL)
Participants assigned to Arm B will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4500 cGy to the dominant intra-prostatic lesion (DIL). Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).
干预措施: Prostate stereotactic body radiotherapy with DIL boost (Radiation)