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NCT Number: NCT02380274

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

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.

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Key information

Conditions

Prostate Cancer Castration-resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Cancer Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Site USSUB1007, Homewood, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of CRPC Treatment Patterns

    Time frame: 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

  2. Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP)

    Time frame: Baseline

  3. HRQoL as assessed by SF-12v2 Health Survey

    Time frame: Baseline and up to 6 years approximately every 3 months

  4. HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    Time frame: Baseline and up to 6 years approximately every 3-6 months

  5. HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF)

    Time frame: Baseline and up to 6 years approximately every 3 months

  6. HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC)

    Time frame: Baseline and up to 6 years approximately every 3 months

  7. HRQoL as assessed by Work Productivity and Activity Questionnaire: Specific Health Problem (WPAI-SHP)

    Time frame: Baseline and up to 6 years approximately every 3-6 months

  8. HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA)

    Time frame: Baseline and up to 6 years approximately every 3-6 months

Secondary outcomes

  1. Number of patients with Physician Factors for Treatment Decisions

    Time frame: 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Global Development, Inc.

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: TRUMPET

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2015
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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