Spots Global Cancer Trial Database for ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Official Title: A Randomized Phase 2b Study of ZEN003694 in Combination With Enzalutamide Versus Enzalutamide Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT04986423
Study Description
Brief Summary: This is an open-label, randomized, Phase 2b study of ZEN003694 in combination with enzalutamide vs. enzalutamide monotherapy in patients with mCRPC who have progressed on prior abiraterone by PCWG3 criteria. Disease must have progressed on only abiraterone by PCWG3 criteria prior to study entry. The patient population will be separated into two cohorts: Cohort A: Patients with poor response to prior abiraterone defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: \< 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve PSA50 response while on abiraterone Cohort B: Patients with response to prior abiraterone, defined as: * Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL, or; * Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and confirmed PSA50 response
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of California, San Francisco, San Francisco, California, United States
Innovative Clinical Research Institute, Whittier, California, United States
Colorado Urology, Lakewood, Colorado, United States
BRCR Global, Plantation, Florida, United States
Hematology Oncology Clinic, Baton Rouge, Louisiana, United States
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States
Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States
Messino Cancer Center, Asheville, North Carolina, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Anhui Provincial Hospital, Hefei, Anhui, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Liaoning Cancer Hospital, Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotang University, Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Shanghai Tenth People's Hospital, Shanghai, Shanghai, China
First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Contact Details
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