A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy



Status:Not yet recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:February 28, 2019
End Date:December 28, 2027
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

The purpose of this study is to determine if treatment with androgen deprivation therapy
(ADT) plus apalutamide (with or without abiraterone acetate with prednisone [AAP]) before and
after radical prostatectomy in participants with high-risk localized or locally advanced
prostate cancer results in an improvement in pathological complete response (pCR) rate and
metastasis-free survival (MFS), as compared to ADT plus placebo.


Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Candidate for radical prostatectomy as per the investigator

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

- Contraceptive (birth control) use by men (or female partners of men enrolled in the
study who are of childbearing potential or are pregnant) should be consistent with
local regulations regarding the acceptable methods of contraception for those
participating in clinical studies

- Able to receive androgen deprivation therapy (ADT) for up to 1 year, per the
investigator's assessment

Exclusion Criteria:

- Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation
(clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M
stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus
N0) will be assessed by central radiological review. Participants are considered
eligible only if the central radiological review confirms clinical stage M0

- Prior treatment with anti-androgen

- Prior treatment for prostate cancer

- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of
the prostat

- History of any pelvic radiation
We found this trial at
33
sites
823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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109 Bee Street
Charleston, South Carolina 29401
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Cleveland, Ohio 44106
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Denver, Colorado 80211
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Greensboro, North Carolina
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Hooksett, New Hampshire 03106
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9735 Kincey Avenue
Huntersville, North Carolina 28078
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Jacksonville, Florida 32209
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4500 San Pablo Road South
Jacksonville, Florida 32224
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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Morristown, New Jersey 07960
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New Orleans, Louisiana 70112
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Oklahoma City, Oklahoma 73104
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Oklahoma City, Oklahoma 73104
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Omaha, Nebraska 68130
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Richmond, Virginia 23235
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63110
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Shreveport, Louisiana 71106
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750 East Adams Street
Syracuse, New York 13210
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Troy, MI
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Virginia Beach, Virginia 23642
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Wichita, Kansas 67226
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