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

CompletedN/A

Sponsor: Astellas Pharma Global Development, Inc.

Conditions: Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer

Countries: 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.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Homewood, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Yuma, Arizona, United States
Hot Springs, Arkansas, United States
Fresno, California, United States
Highland, California, United States
Laguna Hills, California, United States
Los Angeles, California, United States
Marina del Rey, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Jose, California, United States
Santa Monica, California, United States
Templeton, California, United States
Torrance, California, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Glenwood Springs, Colorado, United States
Norwich, Connecticut, United States
Stamford, Connecticut, United States
Bay Pines, Florida, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Hialeah, Florida, United States
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