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

Study Overview
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Brief Summary
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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.

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

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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CRPC<br>Patients with CRPC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CRPC Treatment Patterns | 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 | Up to 6 years following enrollment onto the study | 
| 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 | 
| 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 | 
| HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA) |  | Baseline and up to 6 years approximately every 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Physician Factors for Treatment Decisions | 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 | Up to 6 years following enrollment onto the study | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer