A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:October 14, 2013
End Date:November 30, 2021

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men
with high-risk non-metastatic castration-resistant prostate cancer.

This Phase 3 clinical trial is an essential step in the evaluation of an investigational
medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN
study is to compare the safety and effectiveness of the investigational medication to placebo
in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill
that looks like the investigational medication but does not contain any active medication, a
dummy pill.

Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug
has been obtained in previous Phase 2 studies. These studies are intended to gather the
additional information about effectiveness and safety that is needed to evaluate the overall
benefit-risk relationship of the drug.

Study participants will take the oral investigational medication daily. One cycle of study
treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your
cancer respond to the study medication.

In order for the researchers to evaluate and compare the study results, there are two
different study groups. Study participants will be randomly (like flipping a coin) assigned
to one of these groups:

- One group will receive their current treatment along with the investigational medication

- One group will receive their current medications along with a placebo

The investigational medication will be given to 2 out of every 3 study participants. Neither
you nor the study staff will know which group you are in. However, in case of a medical
emergency, your study doctor can quickly find out which treatment group you are in.

All participants will continue to receive their current treatment along with either the
investigational medication or a placebo. The selections will be random, and you may remain on
investigational treatment until your disease worsens, or until significant side effects occur
or you can no longer tolerate treatment.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell features with high risk for development
of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or
equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific
antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy)

- Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3
PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per
milliliter (ng/mL)

- Maintain castrate levels of testosterone within 4 weeks prior to randomization and
throughout the study

- Patients currently receiving bone loss prevention treatment with bone-sparing agents
must be on stable doses for at least 4 weeks prior to randomization

- Patients who received a first generation anti-androgen (for example, bicalutamide,
flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND
must show continuing disease (PSA) progression (an increase in PSA) after washout

- At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors,
estrogens, and any other anti-cancer therapy prior to randomization

- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to
randomization

- Eastern Cooperative Oncology Group Performance Status 0 or 1

- Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade
<= 1 or baseline prior to randomization

- Adequate organ function according to protocol-defined criteria

- Administration of growth factors or blood transfusions will not be allowed within 4
weeks of the hematology labs required to confirm eligibility

Exclusion Criteria:

- Presence of confirmed distant metastases, including central nervous system and
vertebral or meningeal involvement

- Symptomatic local or regional disease requiring medical intervention

- Prior treatment with second generation anti-androgens

- Prior treatment with CYP17 inhibitors

- Prior treatment with radiopharmaceutical agents, or any other investigational agent
for non-metastatic castration-resistant prostate cancer

- Prior chemotherapy for prostate cancer except if administered in the
adjuvant/neoadjuvant setting

- History of seizure or condition that may pre-dispose to seizure

- Concurrent therapy with protocol-defined excluded medications

- History or evidence of any of the following conditions: any prior malignancy (other
than adequately treated basal cell or squamous cell skin cancer, superficial bladder
cancer, or any other cancer in situ currently in complete remission) within 5 years
prior to randomization; severe/unstable angina, myocardial infarction, symptomatic
congestive heart failure, arterial or venous thromboembolic events, or clinically
significant ventricular arrhythmias within 6 months prior to randomization;
uncontrolled hypertension; gastrointestinal disorder affecting absorption; active
infection; and, any other condition that, in the opinion of the investigator, would
impair the patient's ability to comply with study procedures
We found this trial at
132
sites
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
1060
mi
from 91732
Abilene, TX
Click here to add this to my saved trials
8190
mi
from 91732
Adelaide,
Click here to add this to my saved trials
2437
mi
from 91732
Albany, NY
Click here to add this to my saved trials
2437
mi
from 91732
Albany, NY
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
922
mi
from 91732
Amarillo, TX
Click here to add this to my saved trials
2343
mi
from 91732
Anchorage, AK
Click here to add this to my saved trials
2309
mi
from 91732
Annapolis, MD
Click here to add this to my saved trials
2319
mi
from 91732
Aventura, FL
Click here to add this to my saved trials
Bala-Cynwyd, Pennsylvania 19004
2371
mi
from 91732
Bala-Cynwyd, PA
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
1691
mi
from 91732
Bay Saint Louis, MS
Click here to add this to my saved trials
712
mi
from 91732
Bend, OR
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2312
mi
from 91732
Boca Raton, FL
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2140
mi
from 91732
Bradenton, FL
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
2114
mi
from 91732
Bryn Mawr, PA
Click here to add this to my saved trials
951
mi
from 91732
Burien, WA
Click here to add this to my saved trials
1793
mi
from 91732
Carmel, IN
Click here to add this to my saved trials
356
mi
from 91732
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29412
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
2115
mi
from 91732
Concord, NC
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
2187
mi
from 91732
Daytona Beach, FL
Click here to add this to my saved trials
1645
mi
from 91732
Decatur, IL
Click here to add this to my saved trials
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
1966
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
5
mi
from 91732
Duarte, CA
Click here to add this to my saved trials
1609
mi
from 91732
Duluth, MN
Click here to add this to my saved trials
976
mi
from 91732
Edmonds, WA
Click here to add this to my saved trials
815
mi
from 91732
Englewood, CO
Click here to add this to my saved trials
2204
mi
from 91732
Fort Myers, FL
Click here to add this to my saved trials
1190
mi
from 91732
Fort Sam Houston, TX
Click here to add this to my saved trials
13
mi
from 91732
Fullerton, CA
Click here to add this to my saved trials
701
mi
from 91732
Glenwood Springs, CO
Click here to add this to my saved trials
627
mi
from 91732
Grand Junction, CO
Click here to add this to my saved trials
1745
mi
from 91732
Green Bay, WI
Click here to add this to my saved trials
Greensboro, North Carolina 27401
2152
mi
from 91732
Greensboro, NC
Click here to add this to my saved trials
Greenville, North Carolina 27834
2290
mi
from 91732
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
2019
mi
from 91732
Greenville, SC
Click here to add this to my saved trials
2430
mi
from 91732
Hackensack, NJ
Click here to add this to my saved trials
2315
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
2555
mi
from 91732
Hooksett, NH
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
1814
mi
from 91732
Jeffersonville, IN
Click here to add this to my saved trials
1341
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
36
mi
from 91732
Laguna Woods, CA
Click here to add this to my saved trials
2313
mi
from 91732
Lancaster, PA
Click here to add this to my saved trials
1894
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
208
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
LawrenceVille, New Jersey 08648
2396
mi
from 91732
LawrenceVille, NJ
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
1654
mi
from 91732
Madison, WI
Click here to add this to my saved trials
1718
mi
from 91732
Maywood, IL
Click here to add this to my saved trials
1297
mi
from 91732
McAllen, TX
Click here to add this to my saved trials
1718
mi
from 91732
Melrose Park, IL
Click here to add this to my saved trials
1586
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
664
mi
from 91732
Meridian, ID
Click here to add this to my saved trials
1648
mi
from 91732
Metairie, LA
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2025
mi
from 91732
Middleburg Heights, OH
Click here to add this to my saved trials
1885
mi
from 91732
Middletown, OH
Click here to add this to my saved trials
1722
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
2451
mi
from 91732
Mineola, NY
Click here to add this to my saved trials
1511
mi
from 91732
Minneapolis, MI
Click here to add this to my saved trials
910
mi
from 91732
Missoula, MT
Click here to add this to my saved trials
2407
mi
from 91732
Morristown, NJ
Click here to add this to my saved trials
2389
mi
from 91732
Mount Laurel, NJ
Click here to add this to my saved trials
1835
mi
from 91732
Muncie, IN
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
2234
mi
from 91732
Myrtle Beach, SC
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
2410
mi
from 91732
New Brunswick, NJ
Click here to add this to my saved trials
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
2114
mi
from 91732
New Port Richey, FL
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
2344
mi
from 91732
Oneida, NY
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
2433
mi
from 91732
Poughkeepsie, NY
Click here to add this to my saved trials
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
2275
mi
from 91732
Rockville, MD
Click here to add this to my saved trials
368
mi
from 91732
Roseville, CA
Click here to add this to my saved trials