A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To assess the local oncologic efficacy of focal cryoablation in men with low-risk, clinically localized prostate cancer, as measured by the ability to obtain all negative biopsy cores at the site of focal ablation of the cancer.
研究概览
简要总结
The purpose of this study is to find out if men, with low-risk prostate, can have the small amount of cancer within their prostate removed by freezing, called Focal Cryoablation or Cryotherapy.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥ 21 years of age with a life expectancy estimated to be > 10-years.
- •Diagnosis of adenocarcinoma of the prostate and confirmed by MSKCC review
- •No prior treatment for prostate cancer
- •ECOG performance status of 0 or 1
- •Prostate cancer clinical stage T1c-T2a
- •PSA < 10ng/mL (this will be the PSA level prompting the prostate biopsy)
- •Prostate Size <60 cc on transrectal ultrasound
排除标准
- •Medically unfit for anesthesia
- •Histology other than adenocarcinoma
- •Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
- •Men who are currently receiving anticoagulant drugs (e.g.: Coumadin, warfarin)
- •Second Step Enrollment
- •Inclusion Criteria:
- •Repeat transrectal prostate biopsy that must meet the following parameters:
- •Minimum of 12 biopsy cores
- •No Biopsy Gleason grade 4 or 5
- •Unilateral cancer (only right-sided or left-sided, not bilateral)
- •No more than 50% cancer in any one biopsy core
- •No more than 25% of cores containing cancer
- •Exclusion Criteria:
- •Medically unfit for anesthesia
- •Histology other than adenocarcinoma
- •Men who have received any hormonal manipulation (antiandrogens; LHRH agonists) within the previous 6 months
- •Men who are currently receiving anticoagulant drugs (e.g.: coumadin, warfarin)
研究组 & 干预措施
Patients scheduled to receive Focal Cryotherapy
After enrollment, patients will undergo a repeat transrectal ultrasound- guided prostate biopsy (minimum of 12 cores) to confirm the low-risk nature of their cancer. For study purposes, patients must meet the original entry crieteria on this repeat biopsy. If the patient meets the repeat-biopsy enrollment criteria, they will be treated with focal cryotherapy, meaning cryoablation of the regions of the prostate containing cancer. Efficacy is defined as all negative biopsy cores at the site of the focal ablation on a repeat transrectal biopsy 6 months after cryoablation. At baseline (prior to the re-staging biopsy), 3 months after focal cryotherapy, and at 6 months after focal cryotherapy (prior to the repeat prostate biopsy used to define efficacy), the patient will complete quality of life questionnaires as standard for all patients in the Urology Service.
干预措施: focal cryotherapy (Procedure)
结局指标
主要结局
To assess the local oncologic efficacy of focal cryoablation in men with low-risk, clinically localized prostate cancer, as measured by the ability to obtain all negative biopsy cores at the site of focal ablation of the cancer.
时间窗: conclusion of the study
次要结局
- To evaluate the change from baseline in quality-of-life indicators following focal cryoablation in patients with low-risk localized prostate cancer.(conclusion of the study)
- To evaluate treatment related tissue changes with ultrasound imaging(at the 6-8 month patient office visit)