Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
TRUMPET
A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States
1 other identifier
observational
1,030
1 country
148
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
148 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedStudy Start
First participant enrolled
March 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2021
CompletedNovember 20, 2024
November 1, 2024
5.8 years
March 2, 2015
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of CRPC Treatment Patterns
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
Up to 6 years following enrollment onto the study
Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP)
Baseline
HRQoL as assessed by SF-12v2 Health Survey
Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Baseline and up to 6 years approximately every 3-6 months
HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF)
Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Baseline and up to 6 years approximately every 3 months
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
HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA)
Baseline and up to 6 years approximately every 3-6 months
Secondary Outcomes (3)
Number of patients with Physician Factors for Treatment Decisions
Up to 6 years following enrollment onto the study
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
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
Study Arms (1)
Patients with CRPC
Patients with CRPC
Eligibility Criteria
Adult male patients diagnosed with CRPC. Eligible patients will be enrolled by urologists and medical oncologists.
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Pfizercollaborator
Study Sites (148)
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 Rch, 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
St 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 Township, 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 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 US1068
The Bronx, New York, 10461, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
APGD, Medical Affairs, Americas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 5, 2015
Study Start
March 27, 2015
Primary Completion
January 14, 2021
Study Completion
January 14, 2021
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.