Clinical trial NCT02380274: Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
Official title: A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Prostate Cancer
Keywords: Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Prostate Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2015-03-05
Enrollment: 1030
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male patients diagnosed with CRPC. Eligible patients will be enrolled by urologists and medical oncologists.

Brief 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.


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.

Primary outcomes:
measure: Number of CRPC Treatment Patterns
timeFrame: Up to 6 years following enrollment onto the study
measure: Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP)
timeFrame: Baseline
measure: HRQoL as assessed by SF-12v2 Health Survey
timeFrame: Baseline and up to 6 years approximately every 3 months
measure: HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: Baseline and up to 6 years approximately every 3-6 months
measure: HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF)
timeFrame: Baseline and up to 6 years approximately every 3 months
measure: HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
timeFrame: Baseline and up to 6 years approximately every 3 months
measure: HRQoL as assessed by Work Productivity and Activity Questionnaire: Specific Health Problem (WPAI-SHP)
timeFrame: Baseline and up to 6 years approximately every 3-6 months
measure: HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA)
timeFrame: Baseline and up to 6 years approximately every 3-6 months
Secondary outcomes:
measure: Number of patients with Physician Factors for Treatment Decisions
timeFrame: Up to 6 years following enrollment onto the study
measure: Number of patients with Clinical outcomes, including PSA values, clinical and/or radiologic evidence of disease progression and overall survival
timeFrame: Up to 6 years following enrollment onto the study
measure: Number of patients with Prognostic factors (e.g., patient and disease characteristics) potentially related to select clinical outcomes and HRQoL
timeFrame: Up to 6 years following enrollment onto the study
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Site USSUB1007
state: Alabama
city: Anchorage
country: United States
facility: Site USSUB1010
state: Alaska
city: Phoenix
country: United States
facility: Site USSUB1111
state: Arizona
city: Scottsdale
country: United States
facility: Site US1104
state: Arizona
city: Tucson
country: United States
facility: Site US1065
state: Arizona
city: Tucson
country: United States
facility: Site USSUB1033
state: Arizona
city: Yuma
country: United States
facility: Site US1121
state: Arizona
city: Hot Springs
country: United States
facility: Site US1198
state: Arkansas
city: Fresno
country: United States
facility: Site US1229
state: California
city: Highland
country: United States
facility: Site US1093
state: California
city: Laguna Hills
country: United States
facility: Site US1085
state: California
city: Los Angeles
country: United States
facility: Site US1087
state: California
city: Marina Del Rey
country: United States
facility: Site USSUB1038
state: California
city: Sacramento
country: United States
facility: Site US1167
state: California
city: San Diego
country: United States
facility: Site USSUB1026
state: California
city: San Diego
country: United States
facility: Site US1089
state: California
city: San Jose
country: United States
facility: Site USSUB1037
state: California
city: Santa Monica
country: United States
facility: Site US1148
state: California
city: Templeton
country: United States
facility: Site USSUB1099
state: California
city: Torrance
country: United States
facility: Site US1055
state: California
city: Denver
country: United States
facility: Site USSUB1001
state: Colorado
city: Englewood
country: United States
facility: Site US1032
state: Colorado
city: Glenwood Springs
country: United States
facility: Site US1147
state: Colorado
city: Norwich
country: United States
facility: Site US1086
state: Connecticut
city: Stamford
country: United States
facility: Site US1160
state: Connecticut
city: Bay Pines
country: United States
facility: Site US1205
state: Florida
city: Daytona Beach
country: United States
facility: Site USSUB1014
state: Florida
city: Fort Lauderdale
country: United States
facility: Site US1129
state: Florida
city: Fort Myers
country: United States
facility: Site US1101
state: Florida
city: Hialeah
country: United States
facility: Site US1073
state: Florida
city: Lakewood Ranch
country: United States
facility: Site US1102
state: Florida
city: Naples
country: United States
facility: Site US1105
state: Florida
city: Naples
country: United States
facility: Site US1108
state: Florida
city: Albany
country: United States
facility: Site US1067
state: Georgia
city: Atlanta
country: United States
facility: Site USSUB1025
state: Georgia
city: Newnan
country: United States
facility: Site US1051
state: Georgia
city: Thomasville
country: United States
facility: Site US1172
state: Georgia
city: Boise
country: United States
facility: Site US1066
state: Idaho
city: Coeur d'Alene
country: United States
facility: Site USSUB1018
state: Idaho
city: Chicago
country: United States
facility: Site US1090
state: Illinois
city: Crystal Lake
country: United States
facility: Site US1184
state: Illinois
city: Glenview
country: United States
facility: Site US1084
state: Illinois
city: Hines
country: United States
facility: Site US1213
state: Illinois
city: North Chicago
country: United States
facility: Site US1204
state: Illinois
city: Urbana
country: United States
facility: Site US1119
state: Illinois
city: Greenwood
country: United States
facility: Site USSUB1035
state: Indiana
city: Jeffersonville
country: United States
facility: Site USSUB1009
state: Indiana
city: Lafayette
country: United States
facility: Site US1201
state: Indiana
city: Davenport
country: United States
facility: Site US1203
state: Iowa
city: Wichita
country: United States
facility: Site USSUB1072
state: Kansas
city: Wichita
country: United States
facility: Site US1079
state: Kansas
city: Ashland
country: United States
facility: Site US1139
state: Kentucky
city: Baton Rouge
country: United States
facility: Site USSUB1049
state: Louisiana
city: Covington
country: United States
facility: Site US1181
state: Louisiana
city: Houma
country: United States
facility: Site US1164
state: Louisiana
city: New Orleans
country: United States
facility: Site US1061
state: Louisiana
city: New Orleans
country: United States
facility: Site US1115
state: Louisiana
city: Shreveport
country: United States
facility: Site US1004
state: Louisiana
city: Lewiston
country: United States
facility: Site US1118
state: Maine
city: Bethesda
country: United States
facility: Site US1052
state: Maryland
city: Greenbelt
country: United States
facility: Site US1133
state: Maryland
city: Towson
country: United States
facility: Site USSUB1042
state: Maryland
city: Worcester
country: United States
facility: Site US1077
state: Massachusetts
city: Worcester
country: United States
facility: Site US1039
state: Massachusetts
city: Detroit
country: United States
facility: Site US1233
state: Michigan
city: Lansing
country: United States
facility: Site US1187
state: Michigan
city: Royal Oak
country: United States
facility: Site US1056
state: Michigan
city: Troy
country: United States
facility: Site USSUB1143
state: Michigan
city: Duluth
country: United States
facility: Site US1174
state: Minnesota
city: Minneapolis
country: United States
facility: Site US1157
state: Minnesota
city: Saint Cloud
country: United States
facility: Site USSUB1063
state: Minnesota
city: Saint Louis Park
country: United States
facility: Site US1151
state: Minnesota
city: Woodbury
country: United States
facility: Site US1120
state: Minnesota
city: Tupelo
country: United States
facility: Site US1080
state: Mississippi
city: Bolivar
country: United States
facility: Site US1144
state: Missouri
city: Columbia
country: United States
facility: Site US1081
state: Missouri
city: Saint Louis
country: United States
facility: Site US1223
state: Missouri
city: Billings
country: United States
facility: Site US1123
state: Montana
city: Billings
country: United States
facility: Site USSUB1062
state: Montana
city: Missoula
country: United States
facility: Site USSUB1048
state: Montana
city: Fremont
country: United States
facility: Site US1070
state: Nebraska
city: Grand Island
country: United States
facility: Site US1165
state: Nebraska
city: Omaha
country: United States
facility: Site US1149
state: Nebraska
city: Omaha
country: United States
facility: Site USSUB1022
state: Nebraska
city: Belleville
country: United States
facility: Site US1166
state: New Jersey
city: Berkeley Heights
country: United States
facility: Site US1169
state: New Jersey
city: Edison
country: United States
facility: Site US1059
state: New Jersey
city: Englewood
country: United States
facility: Site USSUB1006
state: New Jersey
city: Paramus
country: United States
facility: Site US1156
state: New Jersey
city: Voorhees
country: United States
facility: Site USSUB1016
state: New Jersey
city: Albuquerque
country: United States
facility: Site US1053
state: New Mexico
city: Santa Fe
country: United States
facility: Site US1189
state: New Mexico
city: Albany
country: United States
facility: Site USSUB1041
state: New York
city: Bronx
country: United States
facility: Site US1068
state: New York
city: Buffalo
country: United States
facility: Site US1226
state: New York
city: Cheektowaga
country: United States
facility: Site US1142
state: New York
city: East Setauket
country: United States
facility: Site USSUB1023
state: New York
city: Garden City
country: United States
facility: Site US1127
state: New York
city: Jamaica
country: United States
facility: Site US1163
state: New York
city: Manhattan
country: United States
facility: Site US1071
state: New York
city: Mineola
country: United States
facility: Site US1046
state: New York
city: North Hills
country: United States
facility: Site US1054
state: New York
city: Poughkeepsie
country: United States
facility: Site USSUB1012
state: New York
city: Syracuse
country: United States
facility: Site USSUB1043
state: New York
city: Asheville
country: United States
facility: Site US1044
state: North Carolina
city: Concord
country: United States
facility: Site US1064
state: North Carolina
city: Durham
country: United States
facility: Site US1132
state: North Carolina
city: Gastonia
country: United States
facility: Site US1136
state: North Carolina
city: Greenville
country: United States
facility: Site USSUB1017
state: North Carolina
city: Hendersonville
country: United States
facility: Site USSUB1134
state: North Carolina
city: High Point
country: United States
facility: Site US1069
state: North Carolina
city: Pinehurst
country: United States
facility: Site US1030
state: North Carolina
city: Raleigh
country: United States
facility: Site USSUB1036
state: North Carolina
city: Washington
country: United States
facility: Site US1078
state: North Carolina
city: Winston-Salem
country: United States
facility: Site US1074
state: North Carolina
city: Winston-Salem
country: United States
facility: Site US1141
state: North Carolina
city: Cincinnati
country: United States
facility: Site USSUB1011
state: Ohio
city: Middleburg Heights
country: United States
facility: Site USSUB1028
state: Ohio
city: Oklahoma City
country: United States
facility: Site USSUB1058
state: Oklahoma
city: Oklahoma City
country: United States
facility: Site US1137
state: Oklahoma
city: Coos Bay
country: United States
facility: Site US1153
state: Oregon
city: Corvallis
country: United States
facility: Site US1116
state: Oregon
city: Portland
country: United States
facility: Site US1230
state: Oregon
city: Springfield
country: United States
facility: Site USSUB1020
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Site USSUB1003
state: Pennsylvania
city: Lancaster
country: United States
facility: Site US1100
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site US1218
state: Pennsylvania
city: Charleston
country: United States
facility: Site US1224
state: South Carolina
city: Myrtle Beach
country: United States
facility: Site USSUB1002
state: South Carolina
city: Watertown
country: United States
facility: Site USSUB1095
state: South Dakota
city: Chattanooga
country: United States
facility: Site USSUB1031
state: Tennessee
city: Cookeville
country: United States
facility: Site US1024
state: Tennessee
city: Nashville
country: United States
facility: Site US1128
state: Tennessee
city: Nashville
country: United States
facility: Site US1131
state: Tennessee
city: Nashville
country: United States
facility: Site USSUB1088
state: Tennessee
city: Dallas
country: United States
facility: Site US1227
state: Texas
city: Fort Worth
country: United States
facility: Site US1140
state: Texas
city: San Antonio
country: United States
facility: Site US1208
state: Texas
city: Temple
country: United States
facility: Site USSUB1045
state: Texas
city: Salt Lake City
country: United States
facility: Site US1207
state: Utah
city: Richmond
country: United States
facility: Site US1092
state: Virginia
city: Richmond
country: United States
facility: Site US1096
state: Virginia
city: Virginia Beach
country: United States
facility: Site USSUB1005
state: Virginia
city: Bellingham
country: United States
facility: Site US1083
state: Washington
city: Everett
country: United States
facility: Site US1029
state: Washington
city: Tacoma
country: United States
facility: Site US1112
state: Washington
city: La Crosse
country: United States
facility: Site US1122
state: Wisconsin
city: Milwaukee
country: United States
facility: Site US1232
state: Wisconsin
Study officials:
affiliation: APGD, Medical Affairs, Americas
name: Medical Director
role: STUDY_DIRECTOR
References: