A Phase IIA Study of Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

H. Lee Moffitt Cancer Center and Research Institute1 个研究点分布在 1 个国家目标入组 25 人2025年1月10日

适应症Metastatic Castration Sensitive Prostate Cancer

干预措施Luteinizing Hormone-Releasing Hormone (LHRH) analog Androgen Receptor Signal Inhibitor (ARSI)Docetaxel

概览

阶段: 2 期
干预措施: Luteinizing Hormone-Releasing Hormone (LHRH) analog
疾病 / 适应症: Metastatic Castration Sensitive Prostate Cancer
发起方: H. Lee Moffitt Cancer Center and Research Institute
入组人数: 25
试验地点: 1
主要终点: Castration Sensitivity Rate
状态: 进行中（未招募）
最后更新: 3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

This is a prospective single center phase IIa open label nonrandomized study, which aims to test the hypothesis that the duration of castration sensitive phase of stage IV prostate cancer can be prolonged with adaptive androgen deprivation therapy (ADT) and Docetaxel.

注册库

clinicaltrials.gov

开始日期

2025年1月10日

结束日期

2028年11月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

Male

研究者

发起方

H. Lee Moffitt Cancer Center and Research Institute

责任方

Sponsor

入排标准

入选标准

•Biopsy proven prostate cancer and the diagnosis can be established through either prostate biopsy or biopsy of a metastatic lesion.
•No androgen deprivation therapy (ADT) with LHRH analog for more than 4 weeks after the diagnosis of metastatic prostate cancer. Prior ADT in the non-metastatic setting is allowed if it was given \> 2 years prior to the diagnosis of metastatic prostate cancer.
•Achieved \>50% PSA decline and \<4 ng/ml PSA after the run-in period.
•Adequate organ function with absolute neutrophil count \> 1000/l, Hb \> 10 g/dl, Platelet \> 100,000/l, Creatinine and liver enzymes within 1.5 folds of upper limits of normal.
•No uncontrolled arrhythmia; patients with h/o myocardia infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.
•ECOG performance status 0-
•Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of ARSI or docetaxel administration.
•Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration of the study.

排除标准

•Prior treatments with TAK-700/Orteronel, abiraterone, apalutamide or enzalutamide.
•Surgical castration.
•Documented liver or brain metastases
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel (including any drugs formulated with polysorbate 80), or LHRH analog (e.g., leuprolide, triptorelin, relugolix, degarelix)
•Treatment with any investigational compound within 30 days prior to the first dose of study drugs.
•Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of LHRH analog, or previously diagnosed with another malignancy \& have any evidence of residual disease. Patients with early-stage skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
•Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Subjects with delayed healing of wounds, ulcers, and/or bone fractures.

研究组 & 干预措施

Adaptive Androgen Deprivation and Docetaxel Treatment

This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period.

干预措施: Luteinizing Hormone-Releasing Hormone (LHRH) analog

Adaptive Androgen Deprivation and Docetaxel Treatment

This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period.

干预措施: Androgen Receptor Signal Inhibitor (ARSI)

Adaptive Androgen Deprivation and Docetaxel Treatment

This study will consist of various visits: a screening visit, 1-3 visits during the screening standard of care treatment period and visits every 4 weeks during the adaptive therapy period.

干预措施: Docetaxel