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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04108208
Collaborator
(none)
75
Enrollment
30
Locations
2
Arms
77.6
Anticipated Duration (Months)
2.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Dec 17, 2019
Anticipated Primary Completion Date :
Sep 5, 2024
Anticipated Study Completion Date :
Jun 5, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Apalutamide 240 milligram (mg) plus 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.

Drug: Apalutamide
Apalutamide 240 mg (4*60 mg tablets) will be administrated orally once daily.
Other Names:
  • JNJ-56021927
  • ARN-509

    • Drug: Androgen-deprivation Therapy (ADT)
    Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.
    Placebo Comparator: Placebo plus 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.

    Drug: Placebo
    Matching placebo will be administered orally.

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Number of Participants with Clinical Laboratory Abnormalities [Up to 6.6 years]

      Number of participants with clinical laboratory abnormalities will be reported.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital Chinese Academy of Medical Sciences Beijing China 100021
    2 Peking University First Hospital Beijing China 100034
    3 Peking University People's Hospital Beijing China 100044
    4 Beijing Friendship Hospital Beijing China 100050
    5 Peking University Third Hospital Beijing China 100191
    6 Beijing Hospital BeiJing China 100730
    7 Hunan Cancer hospital Changsha China 410013
    8 Sichuan Provincial People's Hospital Chengdu China 610072
    9 Chongqing University Cancer Hospital Chongqing China 400030
    10 Fujian Medical University Union Hospital Fuzhou China 350001
    11 Sun Yat-Sen Memorial Hospital Sun Yat-sen University Guangzhou China 510120
    12 Guangzhou First Municipal People's Hospital Guangzhou China 510180
    13 Zhejiang Provincial People's Hospital Hangzhou China 310000
    14 First affiliated Hospital of Zhejiang University Hangzhou China 310003
    15 Zhejiang Cancer Hospital HangZhou China 310015
    16 Yunnan Cancer Hospital Kunming China 200072
    17 Nanjing Drum Tower Hospital Nanjing China 210008
    18 Jiangsu Cancer Hospital Nanjing China 210009
    19 Ningbo First Hospital Ningbo China 315010
    20 Cancer Hospital, FuDan University Shanghai China 200032
    21 Shanghai Zhongshan Hospital ShangHai China 200032
    22 Huashan Hospital Fudan University Shanghai China 200040
    23 Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai China 200240
    24 The Fifth People's Hospital of Shanghai, Fudan University ShangHai China 200240
    25 Huadong Hospital Affiliated to Fudan University Shanghai China 200400
    26 Liaoning Cancer Hospital & Institute Shenyang China 110042
    27 First Affiliated Hospital, SooChow University Suzhou China 215006
    28 TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology Wuhan China 430030
    29 Wuxi People's Hospital Wuxi China 214023
    30 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710061

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04108208
    Other Study ID Numbers:
    • CR108660
    • 56021927PCR4007
    First Posted:
    Sep 30, 2019
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Androgens

    Study Results

    No Results Posted as of Aug 18, 2022