NCT02946008已完成1 期
A Phase I Trial of Neoadjuvant Stereotactic Body Radiotherapy Prior to Radical Prostatectomy for High Risk Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT
研究概览
简要总结
This is a single-arm prospective non-randomized, non-blinded trial to assess the safety of neoadjuvant stereotactic body radiation therapy (SBRT) before surgery in high risk prostate cancer patients.
Radiation therapy will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
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
- •Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- •Subjects must have a negative bone scan.
- •Subjects must have one of the following risk factors:
- •PSA ≥20 and/or
- •Gleason score ≥8 and/or
- •Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 7th Edition Staging Manual and/or
- •Radiographic pelvic lymph node positive disease and/or
- •At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 3+4, clinical stage = T2b/T2c, ≥50% positive biopsy cores.
- •Subjects must freely sign informed consent to enroll in the study.
- •Subjects must be medically fit to undergo surgery determined by the PI.
- •KPS Karnofsky Performance Status (performance status is an attempt to quantify cancer patients' general well-being and activities of daily life, scores range from 0 to 100 where 100 represents perfect health and 0 represents death): ≥
- •No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
- •Subjects must not have had prior pelvic radiation therapy,
- •Subjects must not have had prior androgen deprivation therapy in the past 6 months.
排除标准
- •Metastatic disease as demonstrated by bone scan, CT scan or MRI (Magnetic Resonance Imaging) of the pelvis, or chest x-ray.
- •Declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
- •History of prior pelvic radiation therapy.
- •History of androgen deprivation therapy within the past 6 months.
研究组 & 干预措施
SBRT
Experimental
Stereotactic Body Radiation Therapy (SBRT) will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
SBRT
Experimental
Stereotactic Body Radiation Therapy (SBRT) will be delivered over 5 treatment sessions for approximately 1.5 weeks total.
干预措施: Radical Prostatectomy (Procedure)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Neoadjuvant SBRT
时间窗: 6-week post-prostatectomy
The MTD is defined as the SBRT dose that with radical prostatectomy induces dose-limiting toxicity in 28% of subjects or less.
次要结局
- Incidence of Urinary Incontinence(up to one year post treatment)
- Incidence of Urinary Bother(up to one year post treatment)
- Incidence of Urinary Stricture(up to one year post treatment)
- Number of Patients with Positive Surgical Margins(4-10 weeks post radiation therapy)
- Rectal Toxicity(up to one year post treatment)
- Number of Patients with Extracapsular Extension(4-10 weeks post radiation therapy)
研究者
研究点 (1)
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