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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04523207
Recruitment Status : Active, not recruiting
First Posted : August 21, 2020
Last Update Posted : May 31, 2023
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 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 : April 2, 2024
Estimated Study Completion Date : May 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Apalutamide + Androgen Deprivation Therapy (ADT)
In 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.
Drug: Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.
Other Name: JNJ-56021927

Drug: ADT
Participants will receive ADT intramuscular or subcutaneously during the main study.

Drug: Relugolix
Participants will receive 120 mg of relugolix following a loading dose of 360 mg of (3 tablets of 120 mg each) relugolix during the sub-study.

Primary Outcome Measures :
  1. Main Study: 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.

  2. Sub-study: Percentage of Participants Maintaining Testosterone Level Less Than (<) 50 Nanograms per Deciliter (ng/dL) Through Day 28 [ Time Frame: Up to Day 28 ]
    Percentage of participants maintaining testosterone level <50 ng/dL through Day 28 will be reported.

Secondary Outcome Measures :
  1. Main Study: 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. Main Study: 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.

  3. Sub-study: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to Day 28 ]
    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.

Information from the National Library of Medicine

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

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)

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

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Sponsors and Collaborators
Janssen Research & Development, LLC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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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: May 31, 2023
Last Verified: May 2023
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
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs