Regional Cryoablation for Localized Adenocarcinoma of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Patient Response
研究概览
简要总结
The goal of this clinical research study is to learn if using cryotherapy to treat only the part of the prostate that contains cancer is an effective treatment for prostate cancer. The safety of this treatment will also be studied. Researchers also want to learn if treating only the part of the prostate with cancer causes less impact on your quality of life than other types of therapies.
详细描述
Cryotherapy (also called cryoablation) is an FDA approved treatment for prostate cancer. It involves placing multiple needles within the prostate and freezing the prostate, which will destroy both the cancerous and normal prostate tissue in a very controlled manner. It is possible to treat less than the whole prostate by only freezing the area of the prostate known to contain the cancer.
For this study, cryotherapy will be performed in a way similar to whole prostate cryotherapy, except the entire prostate will not be frozen. For this study, only that portion of the prostate with the most prostate cancer and the upper half of the opposite side of location of the cancer in the prostate will be treated. All areas of cancer may not be treated.
Cryotherapy:
Cryotherapy is performed under general anesthetic in the operating room. An ultrasound probe is inserted into the rectum to monitor the tissue freezing. A urethral warmer is inserted into the bladder through the penis to maintain the health of the urethra.
Quality-of-Life Questionnaires:
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy.
- •Serum PSA </= 10 ng/mL before prostate biopsy
- •Less than 50% of samples from one side of the prostate positive for prostate cancer.
- •No greater than 50% of a single core total length occupied by prostate cancer.
- •No dominant Gleason 4 component. (e.g.; 4+X is not allowed, but X+4 is eligible)
- •No Gleason 5 component (primary, secondary or tertiary).
- •Subjects may have contralateral positive prostate biopsy in a single core within the eligibility biopsy so long as the involvement of this core is 2mm or less and no Gleason 4 or Gleason 5 pattern exists. This is considered to be Non-Dominant (Contralateral) Tumor Burden and is not exclusionary.
- •In the case that the confirmatory biopsy fails to sample the tumor again, patients will be allowed to continue into the therapeutic phase using the laterality information obtained during the eligibility biopsy.
排除标准
- •Medical History or Concurrent Disease which in the investigators mind places the patient at significant preoperative risk or for which the investigator does not feel this therapy is appropriate. Investigator believes subject is unwilling or unable to comply with study protocol requirements.
- •AUASI (American Urologic Association Symptom Index) score >/=20
- •Active urinary tract infection
- •Active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy.
- •Medical or surgical castration initiated before or after the eligibility biopsy.
- •Patient is unable to provide informed consent.
- •Patients will undergo base line bone scan prior to cryoablation to evaluate for regions of abnormal uptake before therapeutic intervention. Metastatic disease by bone scintigraphy is exclusionary. Bone scans performed within 12 months prior to study entry will be used for study base line purposes and will not need to be repeated, unless clinically indicated.
结局指标
主要结局
Patient Response
时间窗: 6 months
Result of biopsy at 6 months after therapy. A failure event is either a Failure of Patient Selection or a Failure of Treatment.
次要结局
未报告次要终点