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

• ClinicalTrials.gov Identifier: NCT04523207
• Recruitment Status: Recruiting
• First Posted: August 21, 2020
• Last Update Posted: February 26, 2021
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Tracking Information

• First Submitted Date: August 20, 2020
• First Posted Date: August 21, 2020
• Last Update Posted Date: February 26, 2021
• Actual Study Start Date: August 19, 2020
• Estimated Primary Completion Date: December 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2020)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 20, 2020)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostatic Neoplasms

Intervention

• 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.

Study Arms

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).

Interventions:

• Drug: Apalutamide
• Drug: ADT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 20, 2020): 94
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 11, 2023
• Estimated Primary Completion Date: December 11, 2023 (Final data collection date for primary outcome measure)

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 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)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04523207
• Other Study ID Numbers: CR108875; 56021927PCR2041 ( Other Identifier: Janssen Research & Development, LLC )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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

• Responsible Party: Janssen Research & Development, LLC
• Study Sponsor: Janssen Research & Development, LLC
• Collaborators: Not Provided

Investigators

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

• PRS Account: Janssen Research & Development, LLC
• Verification Date: February 2021