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

Prostate Cancer Clinical Trial

— TRUMPET  

Official title:

A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380274
• Other study ID #: ONC-MA-1004
• Status: Completed
• Start date: March 27, 2015
• Est. completion date: January 14, 2021

Study information

• Verified date: February 2021
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Metastatic Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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