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.
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.
Brief Title
Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Prostate Cancer
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.
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.
Inclusion 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
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
Gender
Male
Gender Based
false
Keywords
Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Prostate Cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02380274
Org Class
Industry
Org Full Name
Astellas Pharma Inc
Org Study Id
ONC-MA-1004
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States
Primary Outcomes
Outcome 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
Outcome Measure
Number of CRPC Treatment Patterns
Outcome Time Frame
Up to 6 years following enrollment onto the study
Outcome Measure
Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP)
Outcome Time Frame
Baseline
Outcome Measure
HRQoL as assessed by SF-12v2 Health Survey
Outcome Time Frame
Baseline and up to 6 years approximately every 3 months
Outcome Measure
HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Outcome Time Frame
Baseline and up to 6 years approximately every 3-6 months
Outcome Measure
HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF)
Outcome Time Frame
Baseline and up to 6 years approximately every 3 months
Outcome Measure
HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Outcome Time Frame
Baseline and up to 6 years approximately every 3 months
Outcome Measure
HRQoL as assessed by Work Productivity and Activity Questionnaire: Specific Health Problem (WPAI-SHP)
Outcome Time Frame
Baseline and up to 6 years approximately every 3-6 months
Outcome Measure
HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA)
Outcome Time Frame
Baseline and up to 6 years approximately every 3-6 months
Secondary Outcomes
Outcome 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
Outcome Time Frame
Up to 6 years following enrollment onto the study
Outcome Measure
Number of patients with Physician Factors for Treatment Decisions
Outcome Time Frame
Up to 6 years following enrollment onto the study
Outcome Measure
Number of patients with Clinical outcomes, including PSA values, clinical and/or radiologic evidence of disease progression and overall survival
Outcome Time Frame
Up to 6 years following enrollment onto the study
Outcome Measure
Number of patients with Prognostic factors (e.g., patient and disease characteristics) potentially related to select clinical outcomes and HRQoL
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Adult male patients diagnosed with CRPC. Eligible patients will be enrolled by urologists and medical oncologists.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404
Categories Mesh Debug
Prostate Cancer --- PROSTATIC NEOPLASMS
Prostate Cancer --- GENITAL NEOPLASMS, MALE
Prostate Cancer --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Prostate Cancer --- PROSTATIC DISEASES
MeSH Terms
PROSTATIC NEOPLASMS
GENITAL NEOPLASMS, MALE
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
GENITAL DISEASES, MALE
GENITAL DISEASES
UROGENITAL DISEASES
PROSTATIC DISEASES
MALE UROGENITAL DISEASES