Description:
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.
Title
- Brief Title: Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
- Official Title: A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States
Clinical Trial IDs
- ORG STUDY ID:
ONC-MA-1004
- NCT ID:
NCT02380274
Conditions
- Prostate Cancer
- Castration-resistant Prostate Cancer
- Metastatic Prostate Cancer
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Patients with CRPC | | Patients with CRPC | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of CRPC Treatment Patterns |
Time Frame: | Up to 6 years following enrollment onto the study |
Safety Issue: | |
Description: | 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 |
Secondary Outcome Measures
Measure: | Number of patients with Physician Factors for Treatment Decisions |
Time Frame: | Up to 6 years following enrollment onto the study |
Safety Issue: | |
Description: | 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 |
Measure: | Number of patients with Clinical outcomes, including PSA values, clinical and/or radiologic evidence of disease progression and overall survival |
Time Frame: | Up to 6 years following enrollment onto the study |
Safety Issue: | |
Description: | |
Measure: | Number of patients with Prognostic factors (e.g., patient and disease characteristics) potentially related to select clinical outcomes and HRQoL |
Time Frame: | Up to 6 years following enrollment onto the study |
Safety Issue: | |
Description: | |
Details
Phase: | |
Primary Purpose: | Observational |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Astellas Pharma Global Development, Inc. |
Trial Keywords
- Prostate Cancer
- Castration-resistant Prostate Cancer
- Metastatic Prostate Cancer
Last Updated
December 8, 2020