Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:March 27, 2015
End Date:April 2021

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A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States

The purpose of this study is to describe patterns of care in CRPC patients, as well as
health-related quality of life (HRQoL) outcomes associated with CRPC and its management.

This study will also describe factors influencing treatment decisions including reason(s) for
treatment choices and triggers for treatment changes for CRPC as well as describe clinical
outcomes based on patient characteristics.


Inclusion Criteria:

Patient Inclusion:

- Patient may have M0 or M1 disease

- Confirmed diagnosis of CRPC defined by both Testosterone at castrate levels, as
evidenced by a serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) and Clear progressive
disease, as evidenced by a minimum of two rising PSA levels measured at least 7 days
apart or new clinical or imaging evidence of progressive metastatic disease

- Initiating the first or second line treatment for CRPC: including anti- androgens,
androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy.
Previous first line CRPC treatments are limited to: First generation anti-androgens
(bicalutamide, flutamide, or nilutamide) or Sipuleucel-T

- Patients may be enrolled within 90 days from the time of decision to treat or within
90 days of treatment initiation.

- Willing and able to complete periodic patient-reported outcome (PRO) questionnaires,
with or without assistance

- Estimated life expectancy of ≥ 6 months

Caregiver Inclusion:

- Meets the definition of an unpaid relative or friend who helps the patient with his or
her activities of daily living

- Willing and able to complete caregiver-reported outcome questionnaires over the course
of the patient's participation in the study

Exclusion Criteria:

Patient Exclusion:

- Receiving concomitant treatment for other cancer (excluding basal cell carcinoma,
squamous cell carcinoma and treatment for hormone sensitive prostate cancer) within 6
months prior to enrollment.
We found this trial at
150
sites
Highland, California 92346
2533
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from 02139
Highland, CA
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Albany, Georgia 31701
1034
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Albany, GA
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Albany, New York 12208
138
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Albany, NY
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Albuquerque, New Mexico 87109
1965
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Albuquerque, NM
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Anchorage, Alaska 99503
3366
mi
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Anchorage, AK
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Asheville, North Carolina 28801
771
mi
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Asheville, NC
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Ashland, Kentucky 41101
662
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Ashland, KY
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Atlanta, Georgia 30312
934
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Atlanta, GA
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Bala-Cynwyd, Pennsylvania 19004
269
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Bala-Cynwyd, PA
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Baton Rouge, Louisiana 70809
1378
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Bay Pines, Florida 33744
?
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Belleville, New Jersey 07109
191
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Belleville, NJ
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Bellingham, Washington 98225
2476
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Bellingham, WA
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Berkeley Heights, New Jersey 07922
208
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Berkeley Heights, NJ
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Bethesda, Maryland 20889
391
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Bethesda, MD
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Billings, Montana 59101
1854
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Billings, MT
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Billings, Montana 59101
1854
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Boise, Idaho 83702
2252
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Bolivar, Missouri 65613
1221
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Bolivar, MO
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Bronx, New York 10461
180
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Buffalo, New York 14215
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Charleston, South Carolina 29401
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Chattanooga, Tennessee 37403
915
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Cheektowaga, New York 14225
390
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Cheektowaga, NY
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Chicago, Illinois 60612
847
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Cincinnati, Ohio 45212
732
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Coeur d'Alene, Idaho 83814
2227
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Coeur d'Alene, ID
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Columbia, Missouri 65201
1134
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Concord, North Carolina 28025
699
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Concord, NC
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Cookeville, Tennessee 38501
879
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Coos Bay, Oregon 97420
2643
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Coos Bay, OR
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Corvallis, Oregon 97330
2575
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Covington, Louisiana 70433
1332
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Crystal Lake, Illinois 60010
1024
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Dallas, Texas 75216
1547
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Davenport, Iowa 52807
1000
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Daytona Beach, Florida 32114
1064
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Denver, Colorado 80211
1763
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Detroit, Michigan 48201
?
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Duluth, Minnesota 55805
1074
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Durham, North Carolina 27710
606
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East Setauket, New York 11733
143
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Edison, New Jersey 08837
213
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Englewood, Colorado 80113
1764
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Englewood, New Jersey 07631
179
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Everett, Washington 98201
2472
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Fort Lauderdale, Florida 33308
1233
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Fort Myers, Florida 33908
1245
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Fort Worth, Texas 76104
1574
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Fremont, Nebraska 68025
1302
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Fresno, California 93703
2585
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Garden City, New York 11530
173
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Garden City, NY
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Gastonia, North Carolina 28054
730
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Glenview, Illinois 60201
847
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5323 County Road 154
Glenwood Springs, Colorado 81601
1884
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Grand Island, Nebraska 68803
1433
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Greenbelt, Maryland 20770
381
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Greenville, North Carolina 27834
574
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Greenwood, Indiana 46143
804
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Hendersonville, North Carolina 28792
780
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Hialeah, Florida 33016
1253
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High Point, North Carolina 27262
650
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Hines, Illinois 60141
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Homewood, Alabama 35209
1050
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Hot Springs, Arkansas 71913
1301
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Houma, Louisiana 70360
1401
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Jamaica, New York 11432
181
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Jeffersonville, Indiana 47130
819
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La Crosse, Wisconsin 54601
1018
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3523 Crouch Street
Lafayette, Indiana 47904
826
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Laguna Hills, California 92653
2575
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Lakewood Ranch, Florida 34202
1213
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Lancaster, Pennsylvania 17604
315
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Langhorne, Pennsylvania 19047
249
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Lansing, Michigan 48060
684
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Lewiston, Maine 04240
127
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Los Angeles, California 90048
2588
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Manhattan, New York 10029
183
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Marina del Rey, California 90292
2601
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Middleburg Heights, Ohio 44130
555
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Milwaukee, Wisconsin 53295
?
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Mineola, New York 11540
172
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Minneapolis, Minnesota 55455
1118
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Missoula, Montana 59808
2105
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Myrtle Beach, South Carolina 29572
733
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Naples, Florida 34102
1274
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Naples, Florida 34102
1274
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Nashville, Tennessee 37208
940
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Nashville, Tennessee 37209
948
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Nashville, Tennessee 37232
939
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New Orleans, Louisiana 70112
1356
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New Orleans, Louisiana 70121
1356
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Newnan, Georgia 30265
969
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North Chicago, Illinois 60064
?
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North Hills, New York 11042
172
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Norwich, Connecticut 06360
76
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Oklahoma City, Oklahoma 73120
1490
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Oklahoma City, Oklahoma 73104
1489
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Omaha, Nebraska 68130
1276
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Omaha, Nebraska 68114
1276
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Paramus, New Jersey 07652
182
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