A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
- Conditions
- Prostatic Neoplasms
- Interventions
- Registration Number
- NCT04108208
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 \[PCWG2\]) of apalutamide versus placebo in Chinese participants with high-risk non-metastatic castration resistant prostate cancer (NM-CRPC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 75
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equals to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous androgen deprivation therapy (ADT)
- Castration-resistant prostate cancer (PC) demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA greater than (>) 2 nanogram per milliliter (ng/mL)
- Surgically or medically castrated, with testosterone levels of less than (<) 50 nanogram per deciliter (ng/dL). If the participant is medically castrated, continuous dosing with gonadotropin releasing hormone analog (GnRHa) must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone
- Participants who received a first-generation anti-androgen (example: bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization and must show continuing disease progression (an increase in PSA) after washout
- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization
- Presence of distant metastases, including central nervous system (CNS) and vertebral or meningeal involvement, or history of distant metastases. Exception: Pelvic lymph nodes <2 centimeter in short axis (N1) located below the iliac bifurcation are allowed
- Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis, due to primary tumor (example, tumor obstruction of bladder trigone)
- Prior treatment with cytochrome P450 17 alpha-hydroxylase/17,20-lyase (CYP17) inhibitors (example: abiraterone acetate, orteronel, galerterone, ketoconazole, aminoglutethimide) for PC
- Prior chemotherapy for PC, except if administered in the adjuvant/neoadjuvant setting
- Prior treatment with second generation anti-androgens (example, enzalutamide)
- History of seizure or condition that may pre-dispose to seizure (example: prior stroke within 1 year prior to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Apalutamide 240 milligram (mg) plus ADT Androgen-deprivation Therapy (ADT) Participants will receive apalutamide 240 mg orally daily from Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study along with androgen-deprivation therapy (ADT). Each treatment cycle will consist of 28 days. Placebo plus ADT Placebo Participants will receive matching placebo daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Participants who do not have distant metastasis will switch to treatment with apalutamide after completion of 5 cycles of placebo treatment. Participants who have prostate-specific antigen (PSA) progression prior to completion of 5 cycles of study treatment, will cross over to apalutamide at the time of PSA progression. Each treatment cycle will consist of 28 days. Placebo plus ADT Androgen-deprivation Therapy (ADT) Participants will receive matching placebo daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Participants who do not have distant metastasis will switch to treatment with apalutamide after completion of 5 cycles of placebo treatment. Participants who have prostate-specific antigen (PSA) progression prior to completion of 5 cycles of study treatment, will cross over to apalutamide at the time of PSA progression. Each treatment cycle will consist of 28 days. Apalutamide 240 milligram (mg) plus ADT Apalutamide Participants will receive apalutamide 240 mg orally daily from Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study along with androgen-deprivation therapy (ADT). Each treatment cycle will consist of 28 days.
- Primary Outcome Measures
Name Time Method Time to Prostate Specific Antigen (PSA) Progression (TTPP) Up to 4.9 years TTPP is defined as the time from randomization to the first date of documented PSA progression based on Prostate Cancer Working Group 2 (PCWG2) criteria.
- Secondary Outcome Measures
Name Time Method Number of Participants with Clinical Laboratory Abnormalities Up to 6.6 years Number of participants with clinical laboratory abnormalities will be reported.
Plasma Concentrations of Apalutamide and its Metabolite (N-desmethyl apalutamide) Presdose (Day 1 of Cycles 1, 2, 3, 6); 2 hours postdose (Day 1 of Cycles 1 and 3) (each cycle is of 28 days) Plasma concentrations of apalutamide and its metabolite (N-desmethyl apalutamide) will be assessed after single dose and at steady-state.
Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability Up to 6.6 years An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Prostate Specific Antigen (PSA) Response Rate Up to 6.6 years PSA response rate is defined as the percentage of participants who achieved at least a 50 percent (%) decline in PSA value from baseline assessed by a central laboratory according to PCWG2 criteria.
Trial Locations
- Locations (27)
Hunan Cancer hospital
π¨π³Changsha, China
Fujian Medical University Union Hospital
π¨π³Fuzhou, China
Zhejiang Cancer Hospital
π¨π³Hang Zhou, China
The First Affiliated Hospital Zhejiang University College of Medicine
π¨π³Hangzhou, China
Huashan Hospital Fudan University
π¨π³Shanghai, China
Peking University First Hospital
π¨π³Beijing, China
Beijing Friendship Hospital
π¨π³Beijing, China
Sichuan Provincial Peoples Hospital
π¨π³Chengdu, China
Shanghai Zhongshan Hospital
π¨π³ShangHai, China
First Affiliated Hospital SooChow University
π¨π³Suzhou, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
π¨π³Wuhan, China
The First Affiliated Hospital of Xian Jiaotong University
π¨π³Xian, China
Beijing Hospital
π¨π³Beijing, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
π¨π³Shanghai, China
Huadong Hospital Affiliated to Fudan University
π¨π³Shanghai, China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
π¨π³Guangzhou, China
Zhejiang Provincial People's Hospital
π¨π³Hangzhou, China
Cancer Hospital, FuDan University
π¨π³Shanghai, China
The Fifth People's Hospital of Shanghai, Fudan University
π¨π³Shanghai, China
Cancer Hospital Chinese Academy of Medical Sciences
π¨π³Beijing, China
Chongqing University Cancer Hospital
π¨π³Chongqing, China
Peking University People s Hospital
π¨π³Beijing, China
Peking University Third Hospital
π¨π³Beijing, China
The First Affiliated Hospital of Ningbo University
π¨π³Ningbo, China
Wuxi People s Hospital
π¨π³Wuxi, China
Guangzhou First Municipal People's Hospital
π¨π³Guangzhou, China
Nanjing Drum Tower Hospital
π¨π³Nanjing, China