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
Chicago, Illinois 60612
609
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Chicago, IL
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Albany, Georgia 31701
884
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Albany, GA
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Albany, New York 12208
1307
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Albany, NY
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Albuquerque, New Mexico 87109
524
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Albuquerque, NM
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Anchorage, Alaska 99503
2735
mi
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Anchorage, AK
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Asheville, North Carolina 28801
857
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Asheville, NC
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Ashland, Kentucky 41101
825
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Ashland, KY
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Atlanta, Georgia 30312
801
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Atlanta, GA
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Bala-Cynwyd, Pennsylvania 19004
1221
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Bala-Cynwyd, PA
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Baton Rouge, Louisiana 70809
638
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Bay Pines, Florida 33744
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Belleville, New Jersey 07109
1279
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Bellingham, Washington 98225
1445
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Bellingham, WA
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Berkeley Heights, New Jersey 07922
1263
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Bethesda, Maryland 20889
1123
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Bethesda, MD
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Billings, Montana 59101
780
mi
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Billings, MT
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Billings, Montana 59101
780
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Boise, Idaho 83702
1041
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Boise, ID
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Bolivar, Missouri 65613
241
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Bolivar, MO
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Bronx, New York 10461
1291
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Buffalo, New York 14215
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Charleston, South Carolina 29401
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Chattanooga, Tennessee 37403
720
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Cheektowaga, New York 14225
1062
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Cincinnati, Ohio 45212
728
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Coeur d'Alene, Idaho 83814
1176
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Columbia, Missouri 65201
308
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Concord, North Carolina 28025
968
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Cookeville, Tennessee 38501
688
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Coos Bay, Oregon 97420
1433
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Corvallis, Oregon 97330
1397
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Covington, Louisiana 70433
668
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Crystal Lake, Illinois 60010
421
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Crystal Lake, IL
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Dallas, Texas 75216
347
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Davenport, Iowa 52807
465
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Davenport, IA
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Daytona Beach, Florida 32114
1130
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Denver, Colorado 80211
411
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Detroit, Michigan 48201
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Duluth, Minnesota 55805
688
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Durham, North Carolina 27710
1051
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East Setauket, New York 11733
1334
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Edison, New Jersey 08837
1265
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Englewood, Colorado 80113
407
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Englewood, New Jersey 07631
1288
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Everett, Washington 98201
1413
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Fort Lauderdale, Florida 33308
1307
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Fort Myers, Florida 33908
1206
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Fort Worth, Texas 76104
348
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Fremont, Nebraska 68025
263
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Fresno, California 93703
1206
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Garden City, New York 11530
1306
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Gastonia, North Carolina 28054
938
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Glenview, Illinois 60201
613
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5323 County Road 154
Glenwood Springs, Colorado 81601
523
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Grand Island, Nebraska 68803
210
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Greenbelt, Maryland 20770
1135
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Greenville, North Carolina 27834
1140
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Greenwood, Indiana 46143
644
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Hendersonville, North Carolina 28792
868
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Hialeah, Florida 33016
1313
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High Point, North Carolina 27262
989
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Highland, California 92346
1110
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Hines, Illinois 60141
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Homewood, Alabama 35209
685
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Hot Springs, Arkansas 71913
347
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Houma, Louisiana 70360
695
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Jamaica, New York 11432
1297
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Jeffersonville, Indiana 47130
658
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La Crosse, Wisconsin 54601
541
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3523 Crouch Street
Lafayette, Indiana 47904
616
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Lafayette, IN
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Laguna Hills, California 92653
1149
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Lakewood Ranch, Florida 34202
1145
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Lancaster, Pennsylvania 17604
1163
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Langhorne, Pennsylvania 19047
1238
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Lansing, Michigan 48060
778
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Lewiston, Maine 04240
1498
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Los Angeles, California 90048
1168
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Manhattan, New York 10029
1289
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Marina del Rey, California 90292
1181
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Middleburg Heights, Ohio 44130
887
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Milwaukee, Wisconsin 53295
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Mineola, New York 11540
1305
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Minneapolis, Minnesota 55455
552
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Missoula, Montana 59808
1035
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Myrtle Beach, South Carolina 29572
1096
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Naples, Florida 34102
1232
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Naples, Florida 34102
1232
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Nashville, Tennessee 37208
617
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Nashville, Tennessee 37209
609
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Nashville, Tennessee 37232
618
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New Orleans, Louisiana 70112
697
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New Orleans, Louisiana 70121
697
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Newnan, Georgia 30265
790
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North Chicago, Illinois 60064
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North Hills, New York 11042
1304
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Norwich, Connecticut 06360
1389
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Oklahoma City, Oklahoma 73120
150
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
158
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Omaha, Nebraska 68130
261
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Omaha, Nebraska 68114
261
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Paramus, New Jersey 07652
1283
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