Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
Status: | Active, not recruiting |
---|---|
Conditions: | Prostate Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/13/2019 |
Start Date: | March 27, 2015 |
End Date: | April 2021 |
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.
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.
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.
We found this trial at
150
sites
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