Clinical trial NCT04523207: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24
timeFrame: At Month 24
measure: Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28
timeFrame: From Day -14 through Day 28
Secondary outcomes:
measure: Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12
timeFrame: At Month 12
measure: Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24
timeFrame: At Months 18 and 24
measure: Sub-study: Number of Participants With Treatment-emergent Adverse Events
timeFrame: From 1st dose of study intervention (relugolix on Day -14) up to end of sub-study (Day 28)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Sherman Oaks
country: United States
facility: Skyline Urology
state: California
city: Torrance
country: United States
facility: Genesis Research
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Lakewood
country: United States
facility: Foothills Urology - Golden Off
state: Colorado
city: Hialeah
country: United States
facility: Urological Research Network
state: Florida
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Wichita
country: United States
facility: Wichita Urology Group
state: Kansas
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport - Regional Urology
state: Louisiana
city: Troy
country: United States
facility: Michigan Institute of Urology, PC
state: Michigan
city: Omaha
country: United States
facility: Adult Pediatric Urology & Urogynecology, P.C
state: Nebraska
city: Voorhees
country: United States
facility: New Jersey Urology LLC
state: New Jersey
city: Cheektowaga
country: United States
facility: Great Lakes Physician PC d/b/a Western New York Urology Associates
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Urology
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology Of Virginia, Pllc
state: Virginia
city: Spokane
country: United States
facility: Spokane Urology
state: Washington
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: