Clinical Trials /

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

NCT02380274

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Active, not recruiting

Trial Eligibility

Document

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

NameTypeDescriptionInterventions
Patients with CRPCPatients 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:N/A
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Astellas Pharma Global Development, Inc.

    Trial Keywords

    • Prostate Cancer
    • Castration-resistant Prostate Cancer
    • Metastatic Prostate Cancer

    Last Updated

    February 2, 2018