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

Sponsor
Astellas Pharma Global Development, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02380274
Collaborator
Pfizer (Industry)
1,030
148
69.7
7
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1030 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States
    Actual Study Start Date :
    Mar 27, 2015
    Actual Primary Completion Date :
    Jan 14, 2021
    Actual Study Completion Date :
    Jan 14, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with CRPC

    Patients with CRPC

    Outcome Measures

    Primary Outcome Measures

    1. Number of CRPC Treatment Patterns [Up to 6 years following enrollment onto the study]

      Treatment patterns will be described according to: The distribution and timing of disease assessment methods (PSA, other laboratory testing, imaging); Treatment settings; Physician referral patterns from urologist to oncologist (occurrence and timing of referrals) where applicable; CRPC treatments, including initial choices, sequencing and entry into interventional clinical trials

    2. Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP) [Baseline]

    3. HRQoL as assessed by SF-12v2 Health Survey [Baseline and up to 6 years approximately every 3 months]

    4. HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) [Baseline and up to 6 years approximately every 3-6 months]

    5. HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF) [Baseline and up to 6 years approximately every 3 months]

    6. HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [Baseline and up to 6 years approximately every 3 months]

    7. HRQoL as assessed by Work Productivity and Activity Questionnaire: Specific Health Problem (WPAI-SHP) [Baseline and up to 6 years approximately every 3-6 months]

    8. HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA) [Baseline and up to 6 years approximately every 3-6 months]

    Secondary Outcome Measures

    1. Number of patients with Physician Factors for Treatment Decisions [Up to 6 years following enrollment onto the study]

      Physician-reported primary factor in treatment decision making and identified trigger for change will be categorized as:Progressive disease (by Prostate specific antigen (PSA), radiographic, or other unequivocal clinical progression); Tolerability (Lack of tolerability or intolerable side effects); Availability of investigational product/clinical trial; Specific patient concerns regarding treatment; Insurance coverage/costs; Patient compliance

    2. Number of patients with Clinical outcomes, including PSA values, clinical and/or radiologic evidence of disease progression and overall survival [Up to 6 years following enrollment onto the study]

    3. Number of patients with Prognostic factors (e.g., patient and disease characteristics) potentially related to select clinical outcomes and HRQoL [Up to 6 years following enrollment onto the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site USSUB1007 Homewood Alabama United States 35209
    2 Site USSUB1010 Anchorage Alaska United States 99503
    3 Site USSUB1111 Phoenix Arizona United States 85013
    4 Site US1104 Scottsdale Arizona United States 85251
    5 Site US1065 Tucson Arizona United States 85715
    6 Site USSUB1033 Tucson Arizona United States 85741
    7 Site US1121 Yuma Arizona United States 85364
    8 Site US1198 Hot Springs Arkansas United States 71913
    9 Site US1229 Fresno California United States 93703
    10 Site US1093 Highland California United States 92346
    11 Site US1085 Laguna Hills California United States 92653
    12 Site US1087 Los Angeles California United States 90048
    13 Site USSUB1038 Marina Del Rey California United States 90292
    14 Site US1167 Sacramento California United States 95608
    15 Site USSUB1026 San Diego California United States 92120
    16 Site US1089 San Diego California United States 92123
    17 Site USSUB1037 San Jose California United States 95124
    18 Site US1148 Santa Monica California United States 90404
    19 Site USSUB1099 Templeton California United States 93465
    20 Site US1055 Torrance California United States 90505
    21 Site USSUB1001 Denver Colorado United States 80211
    22 Site US1032 Englewood Colorado United States 80113
    23 Site US1147 Glenwood Springs Colorado United States 81601
    24 Site US1086 Norwich Connecticut United States 06360
    25 Site US1160 Stamford Connecticut United States 06904
    26 Site US1205 Bay Pines Florida United States 33744
    27 Site USSUB1014 Daytona Beach Florida United States 32114
    28 Site US1129 Fort Lauderdale Florida United States 33308
    29 Site US1101 Fort Myers Florida United States 33908
    30 Site US1073 Hialeah Florida United States 33016
    31 Site US1102 Lakewood Ranch Florida United States 34202
    32 Site US1105 Naples Florida United States 34102
    33 Site US1108 Naples Florida United States 34102
    34 Site US1067 Albany Georgia United States 31701
    35 Site USSUB1025 Atlanta Georgia United States 30312
    36 Site US1051 Newnan Georgia United States 30265
    37 Site US1172 Thomasville Georgia United States 31792
    38 Site US1066 Boise Idaho United States 83702
    39 Site USSUB1018 Coeur d'Alene Idaho United States 83814
    40 Site US1090 Chicago Illinois United States 60612
    41 Site US1184 Crystal Lake Illinois United States 60010
    42 Site US1084 Glenview Illinois United States 60201
    43 Site US1213 Hines Illinois United States 60141
    44 Site US1204 North Chicago Illinois United States 60064
    45 Site US1119 Urbana Illinois United States 61801
    46 Site USSUB1035 Greenwood Indiana United States 46143
    47 Site USSUB1009 Jeffersonville Indiana United States 47130
    48 Site US1201 Lafayette Indiana United States 47904
    49 Site US1203 Davenport Iowa United States 52807
    50 Site USSUB1072 Wichita Kansas United States 67208
    51 Site US1079 Wichita Kansas United States 67226
    52 Site US1139 Ashland Kentucky United States 41101
    53 Site USSUB1049 Baton Rouge Louisiana United States 70809
    54 Site US1181 Covington Louisiana United States 70433
    55 Site US1164 Houma Louisiana United States 70360
    56 Site US1061 New Orleans Louisiana United States 70112
    57 Site US1115 New Orleans Louisiana United States 70121
    58 Site US1004 Shreveport Louisiana United States 71106
    59 Site US1118 Lewiston Maine United States 04240
    60 Site US1052 Bethesda Maryland United States 20889
    61 Site US1133 Greenbelt Maryland United States 20770
    62 Site USSUB1042 Towson Maryland United States 21204
    63 Site US1077 Worcester Massachusetts United States 01605
    64 Site US1039 Worcester Massachusetts United States 01655
    65 Site US1233 Detroit Michigan United States 48201
    66 Site US1187 Lansing Michigan United States 48060
    67 Site US1056 Royal Oak Michigan United States 48073
    68 Site USSUB1143 Troy Michigan United States 48084
    69 Site US1174 Duluth Minnesota United States 55805
    70 Site US1157 Minneapolis Minnesota United States 55455
    71 Site USSUB1063 Saint Cloud Minnesota United States 56303
    72 Site US1151 Saint Louis Park Minnesota United States 55416
    73 Site US1120 Woodbury Minnesota United States 55125
    74 Site US1080 Tupelo Mississippi United States 38801
    75 Site US1144 Bolivar Missouri United States 65613
    76 Site US1081 Columbia Missouri United States 65201
    77 Site US1223 Saint Louis Missouri United States 63110
    78 Site US1123 Billings Montana United States 59101
    79 Site USSUB1062 Billings Montana United States 59101
    80 Site USSUB1048 Missoula Montana United States 59808
    81 Site US1070 Fremont Nebraska United States 68025
    82 Site US1165 Grand Island Nebraska United States 68803
    83 Site US1149 Omaha Nebraska United States 68114
    84 Site USSUB1022 Omaha Nebraska United States 68130
    85 Site US1166 Belleville New Jersey United States 07109
    86 Site US1169 Berkeley Heights New Jersey United States 07922
    87 Site US1059 Edison New Jersey United States 08837
    88 Site USSUB1006 Englewood New Jersey United States 07631
    89 Site US1156 Paramus New Jersey United States 07652
    90 Site USSUB1016 Voorhees New Jersey United States 08043
    91 Site US1053 Albuquerque New Mexico United States 87109
    92 Site US1189 Santa Fe New Mexico United States 87505
    93 Site USSUB1041 Albany New York United States 12208
    94 Site US1068 Bronx New York United States 10461
    95 Site US1226 Buffalo New York United States 14215
    96 Site US1142 Cheektowaga New York United States 14225
    97 Site USSUB1023 East Setauket New York United States 11733
    98 Site US1127 Garden City New York United States 11530
    99 Site US1163 Jamaica New York United States 11432
    100 Site US1071 Manhattan New York United States 10029
    101 Site US1046 Mineola New York United States 11540
    102 Site US1054 North Hills New York United States 11042
    103 Site USSUB1012 Poughkeepsie New York United States 12601
    104 Site USSUB1043 Syracuse New York United States 13210
    105 Site US1044 Asheville North Carolina United States 28801
    106 Site US1064 Concord North Carolina United States 28025
    107 Site US1132 Durham North Carolina United States 27710
    108 Site US1136 Gastonia North Carolina United States 28054
    109 Site USSUB1017 Greenville North Carolina United States 27834
    110 Site USSUB1134 Hendersonville North Carolina United States 28792
    111 Site US1069 High Point North Carolina United States 27262
    112 Site US1030 Pinehurst North Carolina United States 28374
    113 Site USSUB1036 Raleigh North Carolina United States 27612
    114 Site US1078 Washington North Carolina United States 27889
    115 Site US1074 Winston-Salem North Carolina United States 27103
    116 Site US1141 Winston-Salem North Carolina United States 27157
    117 Site USSUB1011 Cincinnati Ohio United States 45212
    118 Site USSUB1028 Middleburg Heights Ohio United States 44130
    119 Site USSUB1058 Oklahoma City Oklahoma United States 73104
    120 Site US1137 Oklahoma City Oklahoma United States 73120
    121 Site US1153 Coos Bay Oregon United States 97420
    122 Site US1116 Corvallis Oregon United States 97330
    123 Site US1230 Portland Oregon United States 97239
    124 Site USSUB1020 Springfield Oregon United States 97477
    125 Site USSUB1003 Bala-Cynwyd Pennsylvania United States 19004
    126 Site US1100 Lancaster Pennsylvania United States 17604
    127 Site US1218 Pittsburgh Pennsylvania United States 15240
    128 Site US1224 Charleston South Carolina United States 29401
    129 Site USSUB1002 Myrtle Beach South Carolina United States 29572
    130 Site USSUB1095 Watertown South Dakota United States 57201
    131 Site USSUB1031 Chattanooga Tennessee United States 37403
    132 Site US1024 Cookeville Tennessee United States 38501
    133 Site US1128 Nashville Tennessee United States 37208
    134 Site US1131 Nashville Tennessee United States 37209
    135 Site USSUB1088 Nashville Tennessee United States 37232
    136 Site US1227 Dallas Texas United States 75216
    137 Site US1140 Fort Worth Texas United States 76104
    138 Site US1208 San Antonio Texas United States 78229
    139 Site USSUB1045 Temple Texas United States 76508
    140 Site US1207 Salt Lake City Utah United States 84148
    141 Site US1092 Richmond Virginia United States 23230
    142 Site US1096 Richmond Virginia United States 23235
    143 Site USSUB1005 Virginia Beach Virginia United States 23462
    144 Site US1083 Bellingham Washington United States 98225
    145 Site US1029 Everett Washington United States 98201
    146 Site US1112 Tacoma Washington United States 98431
    147 Site US1122 La Crosse Wisconsin United States 54601
    148 Site US1232 Milwaukee Wisconsin United States 53295

    Sponsors and Collaborators

    • Astellas Pharma Global Development, Inc.
    • Pfizer

    Investigators

    • Study Director: Medical Director, APGD, Medical Affairs, Americas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Global Development, Inc.
    ClinicalTrials.gov Identifier:
    NCT02380274
    Other Study ID Numbers:
    • ONC-MA-1004
    First Posted:
    Mar 5, 2015
    Last Update Posted:
    Mar 4, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Astellas Pharma Global Development, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 4, 2021