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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:

Main Study: The purpose of main 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. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.

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)
RelugolixApalutamide + Androgen Deprivation Therapy (ADT)

Purpose

Main Study: The purpose of main 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. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.

Trial Arms

NameTypeDescriptionInterventions
Apalutamide + Androgen Deprivation Therapy (ADT)ExperimentalIn the main study, participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days). Participants who enrolled in the sub-study will receive apalutamide 240 mg once daily along with relugolix (a type of ADT) 120 mg once daily following a loading dose of 360 mg relugolix orally. Sub-study participants will be receiving relugolix up to Day 28 after which they will be transitioned into the main study from Cycle 2 Day 1 and will continue to receive conventional or oral ADT.
  • Apalutamide
  • ADT
  • Relugolix

Eligibility Criteria

        Inclusion Criteria:

          -  A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive
             study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific
             antigen (PSA) of <= 0.2 nanograms per milliliter (ng/mL). Has not received other
             treatment for prostate cancer

          -  Have recovered from RP procedure and have had no worsening in cardiac risk in the
             peri-operative period 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 can be defined based on PSA alone or biopsy
             or RP specimen as follows: PSA greater than or equal to (>=) 20 ng/ml or; Gleason
             Score >= 9 in any core on biopsy or; Gleason Score >= 8 (4+4 or 5+3) in greater than
             (>) 80 percentage (%) of 2 cores on biopsy 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 on biopsy. The
             determination of high risk may be based on pathology report of biopsy or equivalent
             criteria from radical prostatectomy

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

Primary Outcome Measures

Measure:Main Study: 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:Main Study: 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:Main Study: 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.
Measure:Sub-study: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame:Up to Day 28
Safety Issue:
Description:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

June 18, 2021