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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Apalutamide Drug: ADT Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : December 11, 2023
Estimated Study Completion Date : December 11, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Apalutamide

Arms and Interventions
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Arm Intervention/treatment
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).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523207


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Additional Information:

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04523207    
Other Study ID Numbers: CR108875
56021927PCR2041 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases