Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

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)

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

108

Study ID:

NCT04523207

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 32 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

108

Study ID:

NCT04523207

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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