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

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ClinicalTrials.gov Identifier: NCT02380274
Recruitment Status : Active, not recruiting
First Posted : March 5, 2015
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information
First Submitted Date March 2, 2015
First Posted Date March 5, 2015
Last Update Posted Date March 11, 2019
Actual Study Start Date March 27, 2015
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2016)
  • 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 ]
Original Primary Outcome Measures
 (submitted: March 2, 2015)
  • 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 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 ]
Change History Complete list of historical versions of study NCT02380274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 3, 2016)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: March 2, 2015)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult male patients diagnosed with CRPC. Eligible patients will be enrolled by urologists and medical oncologists.
Condition
  • Prostate Cancer
  • Castration-resistant Prostate Cancer
  • Metastatic Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Patients with CRPC
Patients with CRPC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 4, 2018)
1030
Original Estimated Enrollment
 (submitted: March 2, 2015)
2000
Estimated Study Completion Date April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number NCT02380274
Other Study ID Numbers ONC-MA-1004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor Astellas Pharma Global Development, Inc.
Collaborators Pfizer
Investigators
Study Director: Medical Director APGD, Medical Affairs, Americas
PRS Account Astellas Pharma Inc
Verification Date March 2019