Prostate Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1030

Study ID:

NCT02380274

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Global Development, Inc.

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There are 146 Locations for this study

See Locations Near You

Site USSUB1007
Homewood Alabama, 35209, United States
Site USSUB1010
Anchorage Alaska, 99503, United States
Site USSUB1111
Phoenix Arizona, 85013, United States
Site US1104
Scottsdale Arizona, 85251, United States
Site US1065
Tucson Arizona, 85715, United States
Site USSUB1033
Tucson Arizona, 85741, United States
Site US1121
Yuma Arizona, 85364, United States
Site US1198
Hot Springs Arkansas, 71913, United States
Site US1229
Fresno California, 93703, United States
Site US1093
Highland California, 92346, United States
Site US1085
Laguna Hills California, 92653, United States
Site US1087
Los Angeles California, 90048, United States
Site USSUB1038
Marina Del Rey California, 90292, United States
Site US1167
Sacramento California, 95608, United States
Site USSUB1026
San Diego California, 92120, United States
Site US1089
San Diego California, 92123, United States
Site USSUB1037
San Jose California, 95124, United States
Site US1148
Santa Monica California, 90404, United States
Site USSUB1099
Templeton California, 93465, United States
Site US1055
Torrance California, 90505, United States
Site USSUB1001
Denver Colorado, 80211, United States
Site US1032
Englewood Colorado, 80113, United States
Site US1147
Glenwood Springs Colorado, 81601, United States
Site US1086
Norwich Connecticut, 06360, United States
Site US1160
Stamford Connecticut, 06904, United States
Site US1205
Bay Pines Florida, 33744, United States
Site USSUB1014
Daytona Beach Florida, 32114, United States
Site US1129
Fort Lauderdale Florida, 33308, United States
Site US1101
Fort Myers Florida, 33908, United States
Site US1073
Hialeah Florida, 33016, United States
Site US1102
Lakewood Ranch Florida, 34202, United States
Site US1105
Naples Florida, 34102, United States
Site US1108
Naples Florida, 34102, United States
Site US1067
Albany Georgia, 31701, United States
Site USSUB1025
Atlanta Georgia, 30312, United States
Site US1051
Newnan Georgia, 30265, United States
Site US1172
Thomasville Georgia, 31792, United States
Site US1066
Boise Idaho, 83702, United States
Site USSUB1018
Coeur d'Alene Idaho, 83814, United States
Site US1090
Chicago Illinois, 60612, United States
Site US1184
Crystal Lake Illinois, 60010, United States
Site US1084
Glenview Illinois, 60201, United States
Site US1213
Hines Illinois, 60141, United States
Site US1204
North Chicago Illinois, 60064, United States
Site US1119
Urbana Illinois, 61801, United States
Site USSUB1035
Greenwood Indiana, 46143, United States
Site USSUB1009
Jeffersonville Indiana, 47130, United States
Site US1201
Lafayette Indiana, 47904, United States
Site US1203
Davenport Iowa, 52807, United States
Site USSUB1072
Wichita Kansas, 67208, United States
Site US1079
Wichita Kansas, 67226, United States
Site US1139
Ashland Kentucky, 41101, United States
Site USSUB1049
Baton Rouge Louisiana, 70809, United States
Site US1181
Covington Louisiana, 70433, United States
Site US1164
Houma Louisiana, 70360, United States
Site US1061
New Orleans Louisiana, 70112, United States
Site US1115
New Orleans Louisiana, 70121, United States
Site US1004
Shreveport Louisiana, 71106, United States
Site US1118
Lewiston Maine, 04240, United States
Site US1052
Bethesda Maryland, 20889, United States
Site US1133
Greenbelt Maryland, 20770, United States
Site USSUB1042
Towson Maryland, 21204, United States
Site US1077
Worcester Massachusetts, 01605, United States
Site US1039
Worcester Massachusetts, 01655, United States
Site US1233
Detroit Michigan, 48201, United States
Site US1187
Lansing Michigan, 48060, United States
Site US1056
Royal Oak Michigan, 48073, United States
Site USSUB1143
Troy Michigan, 48084, United States
Site US1174
Duluth Minnesota, 55805, United States
Site US1157
Minneapolis Minnesota, 55455, United States
Site USSUB1063
Saint Cloud Minnesota, 56303, United States
Site US1151
Saint Louis Park Minnesota, 55416, United States
Site US1120
Woodbury Minnesota, 55125, United States
Site US1080
Tupelo Mississippi, 38801, United States
Site US1144
Bolivar Missouri, 65613, United States
Site US1081
Columbia Missouri, 65201, United States
Site US1223
Saint Louis Missouri, 63110, United States
Site US1123
Billings Montana, 59101, United States
Site USSUB1062
Billings Montana, 59101, United States
Site USSUB1048
Missoula Montana, 59808, United States
Site US1070
Fremont Nebraska, 68025, United States
Site US1165
Grand Island Nebraska, 68803, United States
Site US1149
Omaha Nebraska, 68114, United States
Site USSUB1022
Omaha Nebraska, 68130, United States
Site US1166
Belleville New Jersey, 07109, United States
Site US1169
Berkeley Heights New Jersey, 07922, United States
Site US1059
Edison New Jersey, 08837, United States
Site USSUB1006
Englewood New Jersey, 07631, United States
Site US1156
Paramus New Jersey, 07652, United States
Site USSUB1016
Voorhees New Jersey, 08043, United States
Site US1053
Albuquerque New Mexico, 87109, United States
Site US1189
Santa Fe New Mexico, 87505, United States
Site USSUB1041
Albany New York, 12208, United States
Site US1068
Bronx New York, 10461, United States
Site US1226
Buffalo New York, 14215, United States
Site US1142
Cheektowaga New York, 14225, United States
Site USSUB1023
East Setauket New York, 11733, United States
Site US1127
Garden City New York, 11530, United States
Site US1163
Jamaica New York, 11432, United States
Site US1071
Manhattan New York, 10029, United States
Site US1046
Mineola New York, 11540, United States
Site US1054
North Hills New York, 11042, United States
Site USSUB1012
Poughkeepsie New York, 12601, United States
Site USSUB1043
Syracuse New York, 13210, United States
Site US1044
Asheville North Carolina, 28801, United States
Site US1064
Concord North Carolina, 28025, United States
Site US1132
Durham North Carolina, 27710, United States
Site US1136
Gastonia North Carolina, 28054, United States
Site USSUB1017
Greenville North Carolina, 27834, United States
Site USSUB1134
Hendersonville North Carolina, 28792, United States
Site US1069
High Point North Carolina, 27262, United States
Site US1030
Pinehurst North Carolina, 28374, United States
Site USSUB1036
Raleigh North Carolina, 27612, United States
Site US1078
Washington North Carolina, 27889, United States
Site US1074
Winston-Salem North Carolina, 27103, United States
Site US1141
Winston-Salem North Carolina, 27157, United States
Site USSUB1011
Cincinnati Ohio, 45212, United States
Site USSUB1028
Middleburg Heights Ohio, 44130, United States
Site USSUB1058
Oklahoma City Oklahoma, 73104, United States
Site US1137
Oklahoma City Oklahoma, 73120, United States
Site US1153
Coos Bay Oregon, 97420, United States
Site US1116
Corvallis Oregon, 97330, United States
Site US1230
Portland Oregon, 97239, United States
Site USSUB1020
Springfield Oregon, 97477, United States
Site USSUB1003
Bala-Cynwyd Pennsylvania, 19004, United States
Site US1100
Lancaster Pennsylvania, 17604, United States
Site US1218
Pittsburgh Pennsylvania, 15240, United States
Site US1224
Charleston South Carolina, 29401, United States
Site USSUB1002
Myrtle Beach South Carolina, 29572, United States
Site USSUB1095
Watertown South Dakota, 57201, United States
Site USSUB1031
Chattanooga Tennessee, 37403, United States
Site US1024
Cookeville Tennessee, 38501, United States
Site US1128
Nashville Tennessee, 37208, United States
Site US1131
Nashville Tennessee, 37209, United States
Site USSUB1088
Nashville Tennessee, 37232, United States
Site US1227
Dallas Texas, 75216, United States
Site US1140
Fort Worth Texas, 76104, United States
Site US1208
San Antonio Texas, 78229, United States
Site USSUB1045
Temple Texas, 76508, United States
Site US1207
Salt Lake City Utah, 84148, United States
Site US1092
Richmond Virginia, 23230, United States
Site US1096
Richmond Virginia, 23235, United States
Site USSUB1005
Virginia Beach Virginia, 23462, United States
Site US1083
Bellingham Washington, 98225, United States
Site US1029
Everett Washington, 98201, United States
Site US1112
Tacoma Washington, 98431, United States
Site US1122
La Crosse Wisconsin, 54601, United States
Site US1232
Milwaukee Wisconsin, 53295, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1030

Study ID:

NCT02380274

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Global Development, Inc.

How clear is this clinincal trial information?

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