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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Astellas Pharma Inc
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT02380274
First received: March 2, 2015
Last updated: March 30, 2017
Last verified: March 2017
  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.


Condition
Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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

  • Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP) [ Time Frame: Baseline ]
  • HRQoL as assessed by SF-12v2 Health Survey [ Time Frame: Baseline and up to 6 years approximately every 3 months ]
  • 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 ]
  • HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF) [ Time Frame: Baseline and up to 6 years approximately every 3 months ]
  • HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) [ Time Frame: Baseline and up to 6 years approximately every 3 months ]
  • 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 ]
  • 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 Outcome Measures:
  • 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

  • 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 ]
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: March 2015
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with CRPC

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male patients diagnosed with CRPC. Eligible patients will be enrolled by urologists and medical oncologists.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02380274

Contacts
Contact: APGD, Medical Affairs Americas 800-888-7704 ext 5473 Astellas.registration@astellas.com

  Show 152 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Investigators
Study Director: Medical Director APGD, Medical Affairs, Americas
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02380274     History of Changes
Other Study ID Numbers: ONC-MA-1004
Study First Received: March 2, 2015
Last Updated: March 30, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 28, 2017