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

Prostatic Neoplasms Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT04523207
• Other study ID #: CR108875
• Secondary ID: 56021927PCR2041
• Status: Completed
• Phase: Phase 2
• Start date: August 19, 2020
• Est. completion date: October 25, 2023

Study information

• Verified date: December 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 25, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.
• ADT
Participants will receive ADT intramuscular or subcutaneously during the main study.
• 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.

Locations

Country	Name	City	State
United States	Urology Austin	Austin	Texas
United States	MidLantic Urology	Bala-Cynwyd	Pennsylvania
United States	Great Lakes Physician PC d/b/a Western New York Urology Associates	Cheektowaga	New York
United States	The Urology Group	Cincinnati	Ohio
United States	The Urology Center of Colorado	Denver	Colorado
United States	Urological Research Network	Hialeah	Florida
United States	Houston Metro Urology	Houston	Texas
United States	First Urology, PSC	Jeffersonville	Indiana
United States	Foothills Urology - Golden Off	Lakewood	Colorado
United States	Lancaster Urology	Lancaster	Pennsylvania
United States	Arkansas Urology	Little Rock	Arkansas
United States	Idaho Urologic Institute	Meridian	Idaho
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates	Nashville	Tennessee
United States	Adult Pediatric Urology & Urogynecology, P.C	Omaha	Nebraska
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Virginia Urology	Richmond	Virginia
United States	Urology San Antonio Research	San Antonio	Texas
United States	Skyline Urology	Sherman Oaks	California
United States	Ochsner LSU Health Shreveport - Regional Urology	Shreveport	Louisiana
United States	Spokane Urology	Spokane	Washington
United States	Oregon Urology Institute	Springfield	Oregon
United States	Associated Medical Professionals	Syracuse	New York
United States	Genesis Research	Torrance	California
United States	Michigan Institute of Urology, PC	Troy	Michigan
United States	Arizona Urology Specialists	Tucson	Arizona
United States	Arizona Urology Specialists	Tucson	Arizona
United States	Urology Of Virginia, Pllc	Virginia Beach	Virginia
United States	New Jersey Urology LLC	Voorhees	New Jersey
United States	Lexington Urology	West Columbia	South Carolina
United States	The Iowa Clinic	West Des Moines	Iowa
United States	Wichita Urology Group	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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