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

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

NCT02380274•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

Locations (148)

Site USSUB1007

Homewood, Alabama, United States

Site USSUB1010

Anchorage, Alaska, United States

Site USSUB1111

Phoenix, Arizona, United States

Site US1104

Scottsdale, Arizona, United States

Site US1065

Tucson, Arizona, United States

Site USSUB1033

Tucson, Arizona, United States

Site US1121

Yuma, Arizona, United States

Site US1198

Hot Springs, Arkansas, United States

Site US1229

Fresno, California, United States

Site US1093

Highland, California, United States

Key Dates

Start Date

March 27, 2015

Primary Completion Date

January 14, 2021

Completion Date

January 14, 2021

Last Updated

November 20, 2024

Enrollment

1,030

ACTUAL participants

Conditions

Prostate CancerCastration-resistant Prostate CancerMetastatic Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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