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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

NCT04523207

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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: 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

Clinical Trial IDs

  • ORG STUDY ID: CR108875
  • SECONDARY ID: 56021927PCR2041
  • NCT ID: NCT04523207

Conditions

  • Prostatic Neoplasms

Interventions

DrugSynonymsArms
ApalutamideJNJ-56021927Apalutamide + Androgen Deprivation Therapy (ADT)
ADTApalutamide + Androgen Deprivation Therapy (ADT)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Apalutamide + Androgen Deprivation Therapy (ADT)ExperimentalParticipants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 months.
  • Apalutamide
  • ADT

Eligibility 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 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 metastasis or 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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Time to Biochemical Recurrence (BCR)
Time Frame:Month 24
Safety Issue:
Description: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

Measure:Time to BCR
Time Frame:Month 12
Safety Issue:
Description:BCR is defined as a confirmed PSA > 0.2 ng/ml and time to BCR will be analyzed using Kaplan-Meier method.
Measure:Time to Serum Testosterone Recovery
Time Frame:Months 18 and 24
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

August 20, 2020