KCT0004129招募中未知
SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 multi-institution randomized prospective clinical trial evaluating the impact of cytoreductive radical prostatectomy combined with best systemic therapy on oncologic and quality of life outcomes in men with newly diagnosed metastatic prostate cancer
ational Cancer Center0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- Male
入选标准
- •4.1.1 Histologically proven adenocarcinoma of the prostate.
- •4.1.2 Evidence of metastasis by MRI/CT scan, bone scan, or histologic confirmation.
- •4.1.3 Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis).
- •4.1.4 If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET, bone scan and MRI, modality at the discretion of the treating physician).
- •4.1.5 No previous local therapy for prostate cancer (i.e. prostate radiation, cryotherapy, etc.).
- •4.1.6 Give informed consent.
- •4.1.7 Prostate deemed resectable by surgeon.
- •4.1.8 Must be male and 18 years or older
- •4.1.9 Plans to start or has already started ADT no longer than 6 months prior to consent.
- •4.1.10 ECOG Performance Status of 0 or 1.
- •4.1.11 Organ functions compatible for surgery.
- •HgB = 9 g/dL
- •Platelets >80,000/mcL
- •AST = 2x ULN
排除标准
- •4.2.1 Males under the age of 18.
- •4.2.2 Refuses to give informed consent.
- •4.2.3 Deemed to have unresectable disease by surgeon.
- •4.2.4 Received ADT for more than 6 months prior to consent.
- •4.2.5 Life expectancy of less than 6 months prior to consent.
- •4.2.6 Known spinal cord compression.
- •4.2.7 DVT/PE in the past 6 months prior to consent.
- •4.2.8 Previous local therapy for prostate cancer.
- •4.2.9 Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent.
研究者
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