A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)

Prostatic Neoplasms Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Participants With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04108208
• Other study ID #: CR108660
• Secondary ID: 56021927PCR4007
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 17, 2019
• Est. completion date: June 5, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: June 5, 2026
• Est. primary completion date: September 5, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Apalutamide
Apalutamide 240 mg (4*60 mg tablets) will be administrated orally once daily.
• Placebo
Matching placebo will be administered orally.
• Androgen-deprivation Therapy (ADT)
Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing
China	Beijing Hospital	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People s Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	Hunan Cancer hospital	Changsha
China	Sichuan Provincial Peoples Hospital	Chengdu
China	Chongqing University Cancer Hospital	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou
China	Guangzhou First Municipal People's Hospital	Guangzhou
China	Sun Yat-Sen Memorial Hospital Sun Yat-sen University	Guangzhou
China	Zhejiang Cancer Hospital	Hang Zhou
China	The First Affiliated Hospital Zhejiang University College of Medicine	Hangzhou
China	Zhejiang Provincial People's Hospital	Hangzhou
China	Nanjing Drum Tower Hospital	Nanjing
China	The First Affiliated Hospital of Ningbo University	Ningbo
China	Cancer Hospital, FuDan University	Shanghai
China	Huadong Hospital Affiliated to Fudan University	Shanghai
China	Huashan Hospital Fudan University	Shanghai
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Zhongshan Hospital	ShangHai
China	The Fifth People's Hospital of Shanghai, Fudan University	Shanghai
China	First Affiliated Hospital SooChow University	Suzhou
China	TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology	Wuhan
China	Wuxi People s Hospital	Wuxi
China	The First Affiliated Hospital of Xian Jiaotong University	Xian

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Prostate Specific Antigen (PSA) Progression (TTPP)	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.	Up to 4.9 years
Secondary	Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability	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.	Up to 6.6 years
Secondary	Number of Participants with Clinical Laboratory Abnormalities	Number of participants with clinical laboratory abnormalities will be reported.	Up to 6.6 years
Secondary	Prostate Specific Antigen (PSA) Response Rate	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.	Up to 6.6 years
Secondary	Plasma Concentrations of Apalutamide and its Metabolite (N-desmethyl apalutamide)	Plasma concentrations of apalutamide and its metabolite (N-desmethyl apalutamide) will be assessed after single dose and at steady-state.	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)