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

NCT ID: NCT02380274

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1030 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-27

Study Completion Date

2021-01-14

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Castration-resistant Prostate Cancer Metastatic Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with CRPC

Patients with CRPC

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

APGD, Medical Affairs, Americas

Locations

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Site USSUB1007

Homewood, Alabama, United States

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Site USSUB1010

Anchorage, Alaska, United States

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Site USSUB1111

Phoenix, Arizona, United States

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Site US1104

Scottsdale, Arizona, United States

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Site US1065

Tucson, Arizona, United States

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Tucson, Arizona, United States

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Site US1121

Yuma, Arizona, United States

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Site US1198

Hot Springs, Arkansas, United States

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Site US1229

Fresno, California, United States

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Site US1093

Highland, California, United States

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Site US1085

Laguna Hills, California, United States

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Los Angeles, California, United States

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Marina del Rey, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Site US1089

San Diego, California, United States

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San Jose, California, United States

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Site US1148

Santa Monica, California, United States

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Templeton, California, United States

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Site US1055

Torrance, California, United States

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Denver, Colorado, United States

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Englewood, Colorado, United States

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Site US1147

Glenwood Springs, Colorado, United States

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Site US1086

Norwich, Connecticut, United States

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Stamford, Connecticut, United States

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Site US1205

Bay Pines, Florida, United States

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Daytona Beach, Florida, United States

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Site US1129

Fort Lauderdale, Florida, United States

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Site US1101

Fort Myers, Florida, United States

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Site US1073

Hialeah, Florida, United States

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Site US1102

Lakewood Rch, Florida, United States

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Site US1105

Naples, Florida, United States

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Site US1108

Naples, Florida, United States

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Site US1067

Albany, Georgia, United States

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Site USSUB1025

Atlanta, Georgia, United States

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Site US1051

Newnan, Georgia, United States

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Site US1172

Thomasville, Georgia, United States

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Site US1066

Boise, Idaho, United States

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Coeur d'Alene, Idaho, United States

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Site US1090

Chicago, Illinois, United States

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Site US1184

Crystal Lake, Illinois, United States

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Site US1084

Glenview, Illinois, United States

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Site US1213

Hines, Illinois, United States

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Site US1204

North Chicago, Illinois, United States

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Site US1119

Urbana, Illinois, United States

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Greenwood, Indiana, United States

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Jeffersonville, Indiana, United States

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Lafayette, Indiana, United States

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Davenport, Iowa, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Ashland, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Houma, Louisiana, United States

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New Orleans, Louisiana, United States

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Site US1115

New Orleans, Louisiana, United States

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Site US1004

Shreveport, Louisiana, United States

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Lewiston, Maine, United States

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Bethesda, Maryland, United States

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Greenbelt, Maryland, United States

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Towson, Maryland, United States

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Worcester, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Lansing, Michigan, United States

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Royal Oak, Michigan, United States

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Troy, Michigan, United States

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Duluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Woodbury, Minnesota, United States

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Tupelo, Mississippi, United States

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Bolivar, Missouri, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Billings, Montana, United States

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Missoula, Montana, United States

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Fremont, Nebraska, United States

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Grand Island, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Belleville, New Jersey, United States

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Site US1169

Berkeley Heights, New Jersey, United States

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Edison, New Jersey, United States

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Site USSUB1006

Englewood, New Jersey, United States

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Site US1156

Paramus, New Jersey, United States

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Site USSUB1016

Voorhees Township, New Jersey, United States

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Albuquerque, New Mexico, United States

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Site US1189

Santa Fe, New Mexico, United States

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Albany, New York, United States

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Buffalo, New York, United States

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Cheektowaga, New York, United States

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East Setauket, New York, United States

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Garden City, New York, United States

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Jamaica, New York, United States

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Manhattan, New York, United States

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Mineola, New York, United States

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North Hills, New York, United States

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Poughkeepsie, New York, United States

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Syracuse, New York, United States

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Site US1068

The Bronx, New York, United States

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Site US1044

Asheville, North Carolina, United States

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Site US1064

Concord, North Carolina, United States

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Durham, North Carolina, United States

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Site US1136

Gastonia, North Carolina, United States

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Greenville, North Carolina, United States

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Hendersonville, North Carolina, United States

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High Point, North Carolina, United States

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Pinehurst, North Carolina, United States

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Raleigh, North Carolina, United States

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Washington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Site US1141

Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Site US1137

Oklahoma City, Oklahoma, United States

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Site US1153

Coos Bay, Oregon, United States

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Site US1116

Corvallis, Oregon, United States

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Portland, Oregon, United States

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Springfield, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Site US1224

Charleston, South Carolina, United States

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Site USSUB1002

Myrtle Beach, South Carolina, United States

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Site USSUB1095

Watertown, South Dakota, United States

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Site USSUB1031

Chattanooga, Tennessee, United States

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Site US1024

Cookeville, Tennessee, United States

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Site US1128

Nashville, Tennessee, United States

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Site US1131

Nashville, Tennessee, United States

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Site USSUB1088

Nashville, Tennessee, United States

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Site US1227

Dallas, Texas, United States

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Site US1140

Fort Worth, Texas, United States

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Site US1208

San Antonio, Texas, United States

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Site USSUB1045

Temple, Texas, United States

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Site US1207

Salt Lake City, Utah, United States

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Site US1092

Richmond, Virginia, United States

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Site US1096

Richmond, Virginia, United States

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Site USSUB1005

Virginia Beach, Virginia, United States

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Site US1083

Bellingham, Washington, United States

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Site US1029

Everett, Washington, United States

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Site US1112

Tacoma, Washington, United States

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Site US1122

La Crosse, Wisconsin, United States

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Site US1232

Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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ONC-MA-1004

Identifier Type: -

Identifier Source: org_study_id

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