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A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

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ClinicalTrials.gov Identifier: NCT04523207
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE August 20, 2020
First Posted Date  ICMJE August 21, 2020
Last Update Posted Date February 26, 2021
Actual Study Start Date  ICMJE August 19, 2020
Estimated Primary Completion Date December 11, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
Time to Biochemical Recurrence (BCR) [ Time Frame: Month 24 ]
BCR is defined as a confirmed prostate specific antigen (PSA) greater than (>) 0.2 nanogram per milliliter (ng/ml) and time to BCR will be analyzed using Kaplan-Meier method.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • Time to BCR [ Time Frame: Month 12 ]
    BCR is defined as a confirmed PSA > 0.2 ng/ml and time to BCR will be analyzed using Kaplan-Meier method.
  • Time to Serum Testosterone Recovery [ Time Frame: Months 18 and 24 ]
    The testosterone recovery, defined as a serum testosterone greater than or equal to (>=)150 nanograms per deciliter (ng/dL) which will be analyzed using Kaplan-Meier method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Official Title  ICMJE A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Brief Summary The purpose of this study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Drug: Apalutamide
    Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets.
    Other Name: JNJ-56021927
  • Drug: ADT
    Participants will receive ADT intramuscular or subcutaneously.
Study Arms  ICMJE Experimental: Apalutamide + Androgen Deprivation Therapy (ADT)
Participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days).
Interventions:
  • Drug: Apalutamide
  • Drug: ADT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2020)
94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 11, 2023
Estimated Primary Completion Date December 11, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A candidate for radical prostatectomy (RP) or status post (less than or equal to (<=) 60 days) RP. Post RP prostate-specific antigen (PSA) of <= 0.2 nanograms per milliliter (ng/mL) and who has not received other treatment for prostate cancer
  • Have recovered from RP procedure, per the clinical judgement of the investigator
  • Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician
  • Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1
  • Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk is defined as: PSA greater than or equal to (>=) 20 ng/ml or; Gleason Score >= 9 in any core or; Gleason Score >= 8 (4+4 or 5+3) in greater than (>) 80 percentage (%) of 2 continuous cores or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3

Exclusion Criteria:

  • History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (<) 2 centimeter (cm) in diameter [short axis] either radiographically or pathologically are allowed.)
  • History of bilateral orchiectomy
  • Received an investigational intervention <= 4 weeks before the planned first dose of study intervention
  • History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
  • Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04523207
Other Study ID Numbers  ICMJE CR108875
56021927PCR2041 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP