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

March 2, 2021 updated by: Astellas Pharma Global Development, Inc.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1030

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Adult male patients diagnosed with CRPC. Eligible patients will be enrolled by urologists and medical oncologists.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with CRPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CRPC Treatment Patterns
Time Frame: 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
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)
Time Frame: Baseline
Baseline
HRQoL as assessed by SF-12v2 Health Survey
Time Frame: Baseline and up to 6 years approximately every 3 months
Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time Frame: Baseline and up to 6 years approximately every 3-6 months
Baseline and up to 6 years approximately every 3-6 months
HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF)
Time Frame: Baseline and up to 6 years approximately every 3 months
Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Time Frame: Baseline and up to 6 years approximately every 3 months
Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Work Productivity and Activity Questionnaire: Specific Health Problem (WPAI-SHP)
Time Frame: Baseline and up to 6 years approximately every 3-6 months
Baseline and up to 6 years approximately every 3-6 months
HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA)
Time Frame: Baseline and up to 6 years approximately every 3-6 months
Baseline and up to 6 years approximately every 3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Physician Factors for Treatment Decisions
Time Frame: 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
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
Time Frame: Up to 6 years following enrollment onto the study
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
Time Frame: Up to 6 years following enrollment onto the study
Up to 6 years following enrollment onto the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Global Development, Inc.

Collaborators

Pfizer

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2015

Primary Completion (Actual)

January 14, 2021

Study Completion (Actual)

January 14, 2021

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-MA-1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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