Prostate Cancer Clinical Trial
— TRUMPETOfficial title:
A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States
| NCT number | NCT02380274 |
| Other study ID # | ONC-MA-1004 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 27, 2015 |
| Est. completion date | January 14, 2021 |
| Verified date | February 2021 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1030 |
| Est. completion date | January 14, 2021 |
| Est. primary completion date | January 14, 2021 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site US1067 | Albany | Georgia |
| United States | Site USSUB1041 | Albany | New York |
| United States | Site US1053 | Albuquerque | New Mexico |
| United States | Site USSUB1010 | Anchorage | Alaska |
| United States | Site US1044 | Asheville | North Carolina |
| United States | Site US1139 | Ashland | Kentucky |
| United States | Site USSUB1025 | Atlanta | Georgia |
| United States | Site USSUB1003 | Bala-Cynwyd | Pennsylvania |
| United States | Site USSUB1049 | Baton Rouge | Louisiana |
| United States | Site US1205 | Bay Pines | Florida |
| United States | Site US1166 | Belleville | New Jersey |
| United States | Site US1083 | Bellingham | Washington |
| United States | Site US1169 | Berkeley Heights | New Jersey |
| United States | Site US1052 | Bethesda | Maryland |
| United States | Site US1123 | Billings | Montana |
| United States | Site USSUB1062 | Billings | Montana |
| United States | Site US1066 | Boise | Idaho |
| United States | Site US1144 | Bolivar | Missouri |
| United States | Site US1068 | Bronx | New York |
| United States | Site US1226 | Buffalo | New York |
| United States | Site US1224 | Charleston | South Carolina |
| United States | Site USSUB1031 | Chattanooga | Tennessee |
| United States | Site US1142 | Cheektowaga | New York |
| United States | Site US1090 | Chicago | Illinois |
| United States | Site USSUB1011 | Cincinnati | Ohio |
| United States | Site USSUB1018 | Coeur d'Alene | Idaho |
| United States | Site US1081 | Columbia | Missouri |
| United States | Site US1064 | Concord | North Carolina |
| United States | Site US1024 | Cookeville | Tennessee |
| United States | Site US1153 | Coos Bay | Oregon |
| United States | Site US1116 | Corvallis | Oregon |
| United States | Site US1181 | Covington | Louisiana |
| United States | Site US1184 | Crystal Lake | Illinois |
| United States | Site US1227 | Dallas | Texas |
| United States | Site US1203 | Davenport | Iowa |
| United States | Site USSUB1014 | Daytona Beach | Florida |
| United States | Site USSUB1001 | Denver | Colorado |
| United States | Site US1233 | Detroit | Michigan |
| United States | Site US1174 | Duluth | Minnesota |
| United States | Site US1132 | Durham | North Carolina |
| United States | Site USSUB1023 | East Setauket | New York |
| United States | Site US1059 | Edison | New Jersey |
| United States | Site US1032 | Englewood | Colorado |
| United States | Site USSUB1006 | Englewood | New Jersey |
| United States | Site US1029 | Everett | Washington |
| United States | Site US1129 | Fort Lauderdale | Florida |
| United States | Site US1101 | Fort Myers | Florida |
| United States | Site US1140 | Fort Worth | Texas |
| United States | Site US1070 | Fremont | Nebraska |
| United States | Site US1229 | Fresno | California |
| United States | Site US1127 | Garden City | New York |
| United States | Site US1136 | Gastonia | North Carolina |
| United States | Site US1084 | Glenview | Illinois |
| United States | Site US1147 | Glenwood Springs | Colorado |
| United States | Site US1165 | Grand Island | Nebraska |
| United States | Site US1133 | Greenbelt | Maryland |
| United States | Site USSUB1017 | Greenville | North Carolina |
| United States | Site USSUB1035 | Greenwood | Indiana |
| United States | Site USSUB1134 | Hendersonville | North Carolina |
| United States | Site US1073 | Hialeah | Florida |
| United States | Site US1069 | High Point | North Carolina |
| United States | Site US1093 | Highland | California |
| United States | Site US1213 | Hines | Illinois |
| United States | Site USSUB1007 | Homewood | Alabama |
| United States | Site US1198 | Hot Springs | Arkansas |
| United States | Site US1164 | Houma | Louisiana |
| United States | Site US1163 | Jamaica | New York |
| United States | Site USSUB1009 | Jeffersonville | Indiana |
| United States | Site US1122 | La Crosse | Wisconsin |
| United States | Site US1201 | Lafayette | Indiana |
| United States | Site US1085 | Laguna Hills | California |
| United States | Site US1102 | Lakewood Ranch | Florida |
| United States | Site US1100 | Lancaster | Pennsylvania |
| United States | Site US1187 | Lansing | Michigan |
| United States | Site US1118 | Lewiston | Maine |
| United States | Site US1087 | Los Angeles | California |
| United States | Site US1071 | Manhattan | New York |
| United States | Site USSUB1038 | Marina Del Rey | California |
| United States | Site USSUB1028 | Middleburg Heights | Ohio |
| United States | Site US1232 | Milwaukee | Wisconsin |
| United States | Site US1046 | Mineola | New York |
| United States | Site US1157 | Minneapolis | Minnesota |
| United States | Site USSUB1048 | Missoula | Montana |
| United States | Site USSUB1002 | Myrtle Beach | South Carolina |
| United States | Site US1105 | Naples | Florida |
| United States | Site US1108 | Naples | Florida |
| United States | Site US1128 | Nashville | Tennessee |
| United States | Site US1131 | Nashville | Tennessee |
| United States | Site USSUB1088 | Nashville | Tennessee |
| United States | Site US1061 | New Orleans | Louisiana |
| United States | Site US1115 | New Orleans | Louisiana |
| United States | Site US1051 | Newnan | Georgia |
| United States | Site US1204 | North Chicago | Illinois |
| United States | Site US1054 | North Hills | New York |
| United States | Site US1086 | Norwich | Connecticut |
| United States | Site US1137 | Oklahoma City | Oklahoma |
| United States | Site USSUB1058 | Oklahoma City | Oklahoma |
| United States | Site US1149 | Omaha | Nebraska |
| United States | Site USSUB1022 | Omaha | Nebraska |
| United States | Site US1156 | Paramus | New Jersey |
| United States | Site USSUB1111 | Phoenix | Arizona |
| United States | Site US1030 | Pinehurst | North Carolina |
| United States | Site US1218 | Pittsburgh | Pennsylvania |
| United States | Site US1230 | Portland | Oregon |
| United States | Site USSUB1012 | Poughkeepsie | New York |
| United States | Site USSUB1036 | Raleigh | North Carolina |
| United States | Site US1092 | Richmond | Virginia |
| United States | Site US1096 | Richmond | Virginia |
| United States | Site US1056 | Royal Oak | Michigan |
| United States | Site US1167 | Sacramento | California |
| United States | Site USSUB1063 | Saint Cloud | Minnesota |
| United States | Site US1223 | Saint Louis | Missouri |
| United States | Site US1151 | Saint Louis Park | Minnesota |
| United States | Site US1207 | Salt Lake City | Utah |
| United States | Site US1208 | San Antonio | Texas |
| United States | Site US1089 | San Diego | California |
| United States | Site USSUB1026 | San Diego | California |
| United States | Site USSUB1037 | San Jose | California |
| United States | Site US1189 | Santa Fe | New Mexico |
| United States | Site US1148 | Santa Monica | California |
| United States | Site US1104 | Scottsdale | Arizona |
| United States | Site US1004 | Shreveport | Louisiana |
| United States | Site USSUB1020 | Springfield | Oregon |
| United States | Site US1160 | Stamford | Connecticut |
| United States | Site USSUB1043 | Syracuse | New York |
| United States | Site US1112 | Tacoma | Washington |
| United States | Site USSUB1045 | Temple | Texas |
| United States | Site USSUB1099 | Templeton | California |
| United States | Site US1172 | Thomasville | Georgia |
| United States | Site US1055 | Torrance | California |
| United States | Site USSUB1042 | Towson | Maryland |
| United States | Site USSUB1143 | Troy | Michigan |
| United States | Site US1065 | Tucson | Arizona |
| United States | Site USSUB1033 | Tucson | Arizona |
| United States | Site US1080 | Tupelo | Mississippi |
| United States | Site US1119 | Urbana | Illinois |
| United States | Site USSUB1005 | Virginia Beach | Virginia |
| United States | Site USSUB1016 | Voorhees | New Jersey |
| United States | Site US1078 | Washington | North Carolina |
| United States | Site USSUB1095 | Watertown | South Dakota |
| United States | Site US1079 | Wichita | Kansas |
| United States | Site USSUB1072 | Wichita | Kansas |
| United States | Site US1074 | Winston-Salem | North Carolina |
| United States | Site US1141 | Winston-Salem | North Carolina |
| United States | Site US1120 | Woodbury | Minnesota |
| United States | Site US1039 | Worcester | Massachusetts |
| United States | Site US1077 | Worcester | Massachusetts |
| United States | Site US1121 | Yuma | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Global Development, Inc. | Pfizer |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP) | Baseline | ||
| Primary | HRQoL as assessed by SF-12v2 Health Survey | Baseline and up to 6 years approximately every 3 months | ||
| Primary | HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) | Baseline and up to 6 years approximately every 3-6 months | ||
| Primary | HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF) | Baseline and up to 6 years approximately every 3 months | ||
| Primary | HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) | Baseline and up to 6 years approximately every 3 months | ||
| Primary | 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 | ||
| Primary | HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA) | Baseline and up to 6 years approximately every 3-6 months | ||
| Secondary | Number of patients with Physician Factors for Treatment Decisions | 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 | |
| Secondary | 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 | ||
| Secondary | 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 |
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