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
NCT ID: NCT04523207
Last Updated: 2025-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2020-08-19
2023-10-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Arizona Urology Specialists
Tucson, Arizona, United States
Arizona Urology Specialists
Tucson, Arizona, United States
Arkansas Urology
Little Rock, Arkansas, United States
Skyline Urology
Sherman Oaks, California, United States
Genesis Research
Torrance, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Foothills Urology - Golden Off
Lakewood, Colorado, United States
Urological Research Network
Hialeah, Florida, United States
Idaho Urologic Institute
Meridian, Idaho, United States
First Urology, PSC
Jeffersonville, Indiana, United States
The Iowa Clinic
West Des Moines, Iowa, United States
Wichita Urology Group
Wichita, Kansas, United States
Ochsner LSU Health Shreveport - Regional Urology
Shreveport, Louisiana, United States
Michigan Institute of Urology, PC
Troy, Michigan, United States
Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska, United States
New Jersey Urology LLC
Voorhees Township, New Jersey, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
Cheektowaga, New York, United States
Associated Medical Professionals
Syracuse, New York, United States
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Oregon Urology Institute
Springfield, Oregon, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Lancaster Urology
Lancaster, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Lexington Urology
West Columbia, South Carolina, United States
Urology Associates
Nashville, Tennessee, United States
Urology Austin
Austin, Texas, United States
Houston Metro Urology
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Virginia Urology
Richmond, Virginia, United States
Urology Of Virginia, Pllc
Virginia Beach, Virginia, United States
Spokane Urology
Spokane, Washington, United States
Countries
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References
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Shore N, Hafron J, Saltzstein D, Brown G, Belkoff L, Aggarwal P, Phillips J, Bhaumik A, McGowan T. Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP). J Urol. 2024 Nov;212(5):682-691. doi: 10.1097/JU.0000000000004163. Epub 2024 Aug 1.
Brown G, Belkoff L, Hafron JM, Saltzstein DR, Potdar R, Bhaumik A, Phillips J, McGowan T, Shore ND. Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases. Target Oncol. 2023 Jan;18(1):95-103. doi: 10.1007/s11523-022-00932-8. Epub 2022 Dec 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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56021927PCR2041
Identifier Type: OTHER
Identifier Source: secondary_id
CR108875
Identifier Type: -
Identifier Source: org_study_id
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