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

NCT04108208 | Active Not Recruiting Phase 4 Results DMC

• 2 other identifiers: CR10866056021927PCR4007
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 27

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).

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Time to Prostate Specific Antigen (PSA) Progression (TTPP) Based on Prostate Cancer Working Group 2 (PCWG2) Criteria

  Time to prostate specific antigen progression (TTPP) was defined as the time from randomization to the first date of documented PSA progression based on PCWG2 criteria. PCWG2 was defined as the PSA progression as 1) the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) or more from the Nadir was documented, which was confirmed by a second value obtained 3 or more weeks later. 2) Where no decline from baseline was documented as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 week of treatment. Kaplan-Meier method was used for the analysis.

  From randomization until first documented PSA progression (up to 3 years 3 months)

Secondary Outcomes (4)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

  Up to 6 years 4 months

• Number of Participants With Grade 3 or Higher Abnormalities in Laboratory Values

  Up to 6 years 4 months

• Percentage of Participants Who Achieved Prostate Specific Antigen (PSA) Response (>=50% PSA Reduction)

  Up to 6 years 4 months

• Plasma Concentration of Apalutamide and Its Metabolite (N-desmethyl Apalutamide)

  Presdose: Day 1 of Cycles 1, 2, 3, and 6; 2 hours postdose: Day 1 of Cycles 1 and 3

Study Arms (2)

Apalutamide 240 milligram (mg) plus ADT

EXPERIMENTAL

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.

Drug: Apalutamide; Drug: Androgen-deprivation Therapy (ADT)

Placebo plus ADT

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Androgen-deprivation Therapy (ADT)

Interventions

Apalutamide DRUG

Apalutamide 240 mg (4\*60 mg tablets) will be administrated orally once daily.

Also known as: JNJ-56021927, ARN-509

Apalutamide 240 milligram (mg) plus ADT

Placebo DRUG

Matching placebo will be administered orally.

Placebo plus ADT

Androgen-deprivation Therapy (ADT) DRUG

Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.

Apalutamide 240 milligram (mg) plus ADT; Placebo plus ADT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (27)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Friendship Hospital

Beijing, 100050, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Beijing Hospital

Beijing, 100730, China

Location

Hunan Cancer hospital

Changsha, 410013, China

Location

Sichuan Provincial Peoples Hospital

Chengdu, 610072, China

Location

Chongqing University Cancer Hospital

Chongqing, 400030, China

Location

Fujian Medical University Union Hospital

Fuzhou, 350001, China

Location

Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Guangzhou, 510120, China

Location

Guangzhou First Municipal People's Hospital

Guangzhou, 510180, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, 310000, China

Location

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, 315010, China

Location

Cancer Hospital, FuDan University

Shanghai, 200032, China

Location

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

Huashan Hospital Fudan University

Shanghai, 200040, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200240, China

Location

The Fifth People's Hospital of Shanghai, Fudan University

Shanghai, 200240, China

Location

Huadong Hospital Affiliated to Fudan University

Shanghai, 200400, China

Location

First Affiliated Hospital SooChow University

Suzhou, 215006, China

Location

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Wuhan, 430030, China

Location

Wuxi People s Hospital

Wuxi, 214023, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Study Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: December 17, 2019
• Primary Completion: June 1, 2023
• Study Completion (Estimated): June 5, 2026
• Last Updated: April 13, 2026
• Results First Posted: March 28, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (27)