AzTrials
AzTrials

Prostate CancerTRUMPETNCT02380274

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

An observational study of Prostate Cancer and Castration-resistant Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 148 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
How many people
1,030 participants
Where
148 sitesUnited States
Study dates
27 Mar 2015to 14 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

148 sites in 1 country.

148 sites in 1 country

United States148 sites

  • Site US1067

    Albany, Georgia, 31701

  • Site USSUB1041

    Albany, New York, 12208

  • Site US1053

    Albuquerque, New Mexico, 87109

  • Site USSUB1010

    Anchorage, Alaska, 99503

  • Site US1044

    Asheville, North Carolina, 28801

  • Site US1139

    Ashland, Kentucky, 41101

  • Site USSUB1025

    Atlanta, Georgia, 30312

  • Site USSUB1003

    Bala-Cynwyd, Pennsylvania, 19004

  • Site USSUB1049

    Baton Rouge, Louisiana, 70809

  • Site US1205

    Bay Pines, Florida, 33744

  • Site US1166

    Belleville, New Jersey, 07109

  • Site US1083

    Bellingham, Washington, 98225

  • Site US1169

    Berkeley Heights, New Jersey, 07922

  • Site US1052

    Bethesda, Maryland, 20889

  • Site US1123

    Billings, Montana, 59101

  • Site USSUB1062

    Billings, Montana, 59101

  • Site US1066

    Boise, Idaho, 83702

  • Site US1144

    Bolivar, Missouri, 65613

  • Site US1226

    Buffalo, New York, 14215

  • Site US1224

    Charleston, South Carolina, 29401

  • Site USSUB1031

    Chattanooga, Tennessee, 37403

  • Site US1142

    Cheektowaga, New York, 14225

  • Site US1090

    Chicago, Illinois, 60612

  • Site USSUB1011

    Cincinnati, Ohio, 45212

  • Site USSUB1018

    Coeur d'Alene, Idaho, 83814

  • Site US1081

    Columbia, Missouri, 65201

  • Site US1064

    Concord, North Carolina, 28025

  • Site US1024

    Cookeville, Tennessee, 38501

  • Site US1153

    Coos Bay, Oregon, 97420

  • Site US1116

    Corvallis, Oregon, 97330

  • Site US1181

    Covington, Louisiana, 70433

  • Site US1184

    Crystal Lake, Illinois, 60010

  • Site US1227

    Dallas, Texas, 75216

  • Site US1203

    Davenport, Iowa, 52807

  • Site USSUB1014

    Daytona Beach, Florida, 32114

  • Site USSUB1001

    Denver, Colorado, 80211

  • Site US1233

    Detroit, Michigan, 48201

  • Site US1174

    Duluth, Minnesota, 55805

  • Site US1132

    Durham, North Carolina, 27710

  • Site USSUB1023

    East Setauket, New York, 11733

  • Site US1059

    Edison, New Jersey, 08837

  • Site US1032

    Englewood, Colorado, 80113

  • Site USSUB1006

    Englewood, New Jersey, 07631

  • Site US1029

    Everett, Washington, 98201

  • Site US1129

    Fort Lauderdale, Florida, 33308

  • Site US1101

    Fort Myers, Florida, 33908

  • Site US1140

    Fort Worth, Texas, 76104

  • Site US1070

    Fremont, Nebraska, 68025

  • Site US1229

    Fresno, California, 93703

  • Site US1127

    Garden City, New York, 11530

  • Site US1136

    Gastonia, North Carolina, 28054

  • Site US1084

    Glenview, Illinois, 60201

  • Site US1147

    Glenwood Springs, Colorado, 81601

  • Site US1165

    Grand Island, Nebraska, 68803

  • Site US1133

    Greenbelt, Maryland, 20770

  • Site USSUB1017

    Greenville, North Carolina, 27834

  • Site USSUB1035

    Greenwood, Indiana, 46143

  • Site USSUB1134

    Hendersonville, North Carolina, 28792

  • Site US1073

    Hialeah, Florida, 33016

  • Site US1069

    High Point, North Carolina, 27262

  • Site US1093

    Highland, California, 92346

  • Site US1213

    Hines, Illinois, 60141

  • Site USSUB1007

    Homewood, Alabama, 35209

  • Site US1198

    Hot Springs, Arkansas, 71913

  • Site US1164

    Houma, Louisiana, 70360

  • Site US1163

    Jamaica, New York, 11432

  • Site USSUB1009

    Jeffersonville, Indiana, 47130

  • Site US1122

    La Crosse, Wisconsin, 54601

  • Site US1201

    Lafayette, Indiana, 47904

  • Site US1085

    Laguna Hills, California, 92653

  • Site US1102

    Lakewood Rch, Florida, 34202

  • Site US1100

    Lancaster, Pennsylvania, 17604

  • Site US1187

    Lansing, Michigan, 48060

  • Site US1118

    Lewiston, Maine, 04240

  • Site US1087

    Los Angeles, California, 90048

  • Site US1071

    Manhattan, New York, 10029

  • Site USSUB1038

    Marina del Rey, California, 90292

  • Site USSUB1028

    Middleburg Heights, Ohio, 44130

  • Site US1232

    Milwaukee, Wisconsin, 53295

  • Site US1046

    Mineola, New York, 11540

  • Site US1157

    Minneapolis, Minnesota, 55455

  • Site USSUB1048

    Missoula, Montana, 59808

  • Site USSUB1002

    Myrtle Beach, South Carolina, 29572

  • Site US1105

    Naples, Florida, 34102

  • Site US1108

    Naples, Florida, 34102

  • Site US1128

    Nashville, Tennessee, 37208

  • Site US1131

    Nashville, Tennessee, 37209

  • Site USSUB1088

    Nashville, Tennessee, 37232

  • Site US1061

    New Orleans, Louisiana, 70112

  • Site US1115

    New Orleans, Louisiana, 70121

  • Site US1051

    Newnan, Georgia, 30265

  • Site US1204

    North Chicago, Illinois, 60064

  • Site US1054

    North Hills, New York, 11042

  • Site US1086

    Norwich, Connecticut, 06360

  • Site USSUB1058

    Oklahoma City, Oklahoma, 73104

  • Site US1137

    Oklahoma City, Oklahoma, 73120

  • Site US1149

    Omaha, Nebraska, 68114

  • Site USSUB1022

    Omaha, Nebraska, 68130

  • Site US1156

    Paramus, New Jersey, 07652

  • Site USSUB1111

    Phoenix, Arizona, 85013

  • Site US1030

    Pinehurst, North Carolina, 28374

  • Site US1218

    Pittsburgh, Pennsylvania, 15240

  • Site US1230

    Portland, Oregon, 97239

  • Site USSUB1012

    Poughkeepsie, New York, 12601

  • Site USSUB1036

    Raleigh, North Carolina, 27612

  • Site US1092

    Richmond, Virginia, 23230

  • Site US1096

    Richmond, Virginia, 23235

  • Site US1056

    Royal Oak, Michigan, 48073

  • Site US1167

    Sacramento, California, 95608

  • Site USSUB1063

    Saint Cloud, Minnesota, 56303

  • Site US1151

    Saint Louis Park, Minnesota, 55416

  • Site US1207

    Salt Lake City, Utah, 84148

  • Site US1208

    San Antonio, Texas, 78229

  • Site USSUB1026

    San Diego, California, 92120

  • Site US1089

    San Diego, California, 92123

  • Site USSUB1037

    San Jose, California, 95124

  • Site US1189

    Santa Fe, New Mexico, 87505

  • Site US1148

    Santa Monica, California, 90404

  • Site US1104

    Scottsdale, Arizona, 85251

  • Site US1004

    Shreveport, Louisiana, 71106

  • Site USSUB1020

    Springfield, Oregon, 97477

  • Site US1223

    St Louis, Missouri, 63110

  • Site US1160

    Stamford, Connecticut, 06904

  • Site USSUB1043

    Syracuse, New York, 13210

  • Site US1112

    Tacoma, Washington, 98431

  • Site USSUB1045

    Temple, Texas, 76508

  • Site USSUB1099

    Templeton, California, 93465

  • Site US1068

    The Bronx, New York, 10461

  • Site US1172

    Thomasville, Georgia, 31792

  • Site US1055

    Torrance, California, 90505

  • Site USSUB1042

    Towson, Maryland, 21204

  • Site USSUB1143

    Troy, Michigan, 48084

  • Site US1065

    Tucson, Arizona, 85715

  • Site USSUB1033

    Tucson, Arizona, 85741

  • Site US1080

    Tupelo, Mississippi, 38801

  • Site US1119

    Urbana, Illinois, 61801

  • Site USSUB1005

    Virginia Beach, Virginia, 23462

  • Site USSUB1016

    Voorhees Township, New Jersey, 08043

  • Site US1078

    Washington, North Carolina, 27889

  • Site USSUB1095

    Watertown, South Dakota, 57201

  • Site USSUB1072

    Wichita, Kansas, 67208

  • Site US1079

    Wichita, Kansas, 67226

  • Site US1074

    Winston-Salem, North Carolina, 27103

  • Site US1141

    Winston-Salem, North Carolina, 27157

  • Site US1120

    Woodbury, Minnesota, 55125

  • Site US1077

    Worcester, Massachusetts, 01605

  • Site US1039

    Worcester, Massachusetts, 01655

  • Site US1121

    Yuma, Arizona, 85364

Other trials in United States

About this study

Official title: 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.

Keywords
Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02380274
Study groupRoleWhat they receive
Patients with CRPCPatients with CRPC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 6 years following enrollment onto the study

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

    Measured: Baseline

  3. HRQoL as assessed by SF-12v2 Health Survey

    Measured: Baseline and up to 6 years approximately every 3 months

  4. HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Measured: Baseline and up to 6 years approximately every 3-6 months

  5. HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF)

    Measured: Baseline and up to 6 years approximately every 3 months

  6. HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

    Measured: 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)

    Measured: Baseline and up to 6 years approximately every 3-6 months

  8. HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA)

    Measured: Baseline and up to 6 years approximately every 3-6 months

Secondary outcomes (3)

  1. 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

    Measured: Up to 6 years following enrollment onto the study

  2. Number of patients with Clinical outcomes, including PSA values, clinical and/or radiologic evidence of disease progression and overall survival

    Measured: 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

    Measured: Up to 6 years following enrollment onto the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study start27 Mar 2015
  3. Primary completion14 Jan 2021
  4. Study completion14 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,030 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02380274
Sponsor's protocol ID
ONC-MA-1004
Acronym
TRUMPET
Status last verified
Nov 2024
First submitted
2 Mar 2015
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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/.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Castration-resistant Prostate Cancer, run by Astellas Pharma Global Development, Inc. at 148 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of CRPC Treatment Patterns (time frame: Up to 6 years following enrollment onto the study). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02380274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in