Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
NCT02380274
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
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 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.
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| 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 |
| ||||
| 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 | Completed | ||||
| Actual Enrollment | 1030 | ||||
| Original Estimated Enrollment | 2000 | ||||
| Actual Study Completion Date | January 14, 2021 | ||||
| Actual Primary Completion Date | January 14, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria: Patient Inclusion:
Caregiver Inclusion:
Exclusion Criteria: Patient Exclusion:
| ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| Responsible Party | Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ) | ||||
| Study Sponsor | Astellas Pharma Global Development, Inc. | ||||
| Collaborators | Pfizer | ||||
| Investigators |
| ||||
| PRS Account | Astellas Pharma Inc | ||||
| Verification Date | February 2021 | ||||