Castration-resistant Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer
Conditions
Keywords
Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
Brief 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.
Interventions
None listed
Sponsors
Pfizer
Astellas Pharma Global Development, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA) | Baseline and up to 6 years approximately every 3-6 months | — |
| HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF) | Baseline and up to 6 years approximately every 3 months | — |
| HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) | Baseline and up to 6 years approximately every 3 months | — |
| HRQoL as assessed by Work Productivity and Activity Questionnaire: Specific Health Problem (WPAI-SHP) | Baseline and up to 6 years approximately every 3-6 months | — |
| Number of CRPC Treatment Patterns | Up to 6 years following enrollment onto the study | 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 |
| Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP) | Baseline | — |
| HRQoL as assessed by SF-12v2 Health Survey | Baseline and up to 6 years approximately every 3 months | — |
| HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) | Baseline and up to 6 years approximately every 3-6 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Clinical outcomes, including PSA values, clinical and/or radiologic evidence of disease progression and overall survival | Up to 6 years following enrollment onto the study | — |
| Number of patients with Prognostic factors (e.g., patient and disease characteristics) potentially related to select clinical outcomes and HRQoL | Up to 6 years following enrollment onto the study | — |
| Number of patients with Physician Factors for Treatment Decisions | Up to 6 years following enrollment onto the study | 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 |
Countries
United States
Outcome results
None listed