Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Memorial Sloan Kettering Cancer Center72 个研究点分布在 4 个国家目标入组 732 人2018年6月19日

适应症Prostate Cancer

干预措施Docetaxel 75 mg/m2 Docetaxel 60 mg/m2 Radium-223

概览

阶段: 3 期
干预措施: Docetaxel 75 mg/m2
疾病 / 适应症: Prostate Cancer
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 732
试验地点: 72
主要终点: Overall survival
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

注册库

clinicaltrials.gov

开始日期

2018年6月19日

结束日期

2027年4月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

Memorial Sloan Kettering Cancer Center

责任方

Sponsor

入排标准

入选标准

•Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
•NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
•Males 18 years of age and above
•Histological or cytological proof of prostate cancer
•Documented progressive mCRPC based on at least one of the following criteria:
•PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 1.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 1.0 ng/mL.
•Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
•Progression of bone disease (evaluable disease) or two or more new bone lesions by bone scan.
•Two or more bone lesions
•ECOG 0- 1

排除标准

•Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization.
•°Note: If this requirement to have a washout of 2 weeks or 5 half-lives prior to randomization causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at pcctc@mskcc.org to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start.
•Received external beam radiotherapy within the 4 weeks prior to randomization.
•° Note: If prolonging randomization to complete EBRT washout causes potential treatment delay due to Radium-223 importation timelines, the PCCTC must be contacted at pcctc@mskcc.org to request approval to randomize the subject prior to the completion of the washout. Requests for early randomization must be accompanied by written assurance by the site that the washout will be completed prior to treatment start.
•Has an immediate need for external beam radiotherapy.
•Has received any systemic bone-seeking radiopharmaceutical in the past.
•Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel.
•Has received four or more systemic anticancer regimens for mCRPC.
•Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC
•A 'line' is a regimen. Combinations of hormones and other types of therapies count as single lines.

研究组 & 干预措施

Docetaxel

Docetaxel 75 mg/m2 will be administered IV every three weeks for 10 doses. Prednisone will be given at a dose of 5mg orally twice daily.

干预措施: Docetaxel 75 mg/m2

Docetaxel with Radium-223

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

干预措施: Docetaxel 60 mg/m2

Docetaxel with Radium-223

Docetaxel 60 mg/m2 will be administered IV every 3 weeks for 10 doses. Radium-223 will be administered at 55 kBq/kg, 6 injections at 6 weeks intervals.

干预措施: Radium-223