Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- 3-yr BFFS
研究概览
简要总结
After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients.
The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.
详细描述
The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions.
Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.
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
- •- Able and willing to provide informed consent;
- •Pathologically proven diagnosis of prostatic adenocarcinoma;
- •Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy;
- •No regional or distant metastases;
- •Eastern Cooperative Oncology Group performance status 0-1
排除标准
- •- Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy;
- •Previous radiotherapy to the pelvis;
- •Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying);
- •PSA level at sRT> 2 ng/ml;
- •(Each single) Lesion volume within the prostatic fossa at mpMR >5 cc;
- •Previous chemotherapy for malignancy in past 5 years;
- •Previous androgen deprivation for biochemical failure after RP;
- •Contraindication to short term AD (in case of Px)
- •Presence of nodal or distant metastasis, as confirmed by magnetic resonance (MR) or PET/CT
- •Pathologically positive lymph nodes (pN+) at RP;
- •Serious medical comorbidities or other contraindications to radiotherapy
- •Presence of active inflammatory bowel disease;
- •Presence of active connective tissue disease;
- •Unable or unwilling to complete quality of life questionnaires
结局指标
主要结局
3-yr BFFS
时间窗: 3-years
The primary objective of the study is 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after RP
次要结局
- 3-y OS(3-years)
- 3-y LC(3-years)
- 3-y GU GI tox(3-years)
- 3-y - Patient satisfaction with treatment(3-years)
- 3-y QoL(3-years)
- 3-y MFS(3-years)
研究者
Giuseppe Sanguineti
Professor
Regina Elena Cancer Institute