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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Apalutamide; Drug: ADT; Drug: Relugolix

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Arizona Urology Specialists
    • Tucson, Arizona, United States, 85741
      • Arizona Urology Specialists
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • California
    • Sherman Oaks, California, United States, 91411
      • Skyline Urology
    • Torrance, California, United States, 90505
      • Genesis Research
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
    • Lakewood, Colorado, United States, 80228
      • Foothills Urology - Golden Off
  • Florida
    • Hialeah, Florida, United States, 33016
      • Urological Research Network
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institute
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Wichita Urology Group
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Ochsner LSU Health Shreveport - Regional Urology
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology, PC
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult Pediatric Urology & Urogynecology, P.C
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • New Jersey Urology LLC
  • New York
    • Cheektowaga, New York, United States, 14225
      • Great Lakes Physician PC d/b/a Western New York Urology Associates
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • The Urology Group
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Urology Institute
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • MidLantic Urology
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
    • West Columbia, South Carolina, United States, 20169
      • Lexington Urology
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Urology Associates
  • Texas
    • Austin, Texas, United States, 78745
      • Urology Austin
    • Houston, Texas, United States, 77027
      • Houston Metro Urology
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia Urology
    • Virginia Beach, Virginia, United States, 23462
      • Urology Of Virginia, Pllc
  • Washington
    • Spokane, Washington, United States, 99202
      • Spokane Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Study: Time to Biochemical Recurrence (BCR)	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.	Month 24
Sub-study: Percentage of Participants Maintaining Testosterone Level Less Than (<) 50 Nanograms per Deciliter (ng/dL) Through Day 28	Percentage of participants maintaining testosterone level <50 ng/dL through Day 28 will be reported.	Up to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Study: Time to BCR	BCR is defined as a confirmed PSA > 0.2 ng/ml and time to BCR will be analyzed using Kaplan-Meier method.	Month 12
Main Study: Time to Serum Testosterone Recovery	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.	Months 18 and 24
Sub-study: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	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.	Up to Day 28

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Relugolix
• Other Study ID Numbers: CR108875; 56021927PCR2041 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No