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

NCT02380274

Last updated date
Study Location
Site USSUB1007
Homewood, Alabama, 35209, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate CancerObservational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
NCT02380274
  1. Homewood, Alabama
  2. Anchorage, Alaska
  3. Phoenix, Arizona
  4. Scottsdale, Arizona
  5. Tucson, Arizona
  6. Tucson, Arizona
  7. Yuma, Arizona
  8. Hot Springs, Arkansas
  9. Fresno, California
  10. Highland, California
  11. Laguna Hills, California
  12. Los Angeles, California
  13. Marina Del Rey, California
  14. Sacramento, California
  15. San Diego, California
  16. San Diego, California
  17. San Jose, California
  18. Santa Monica, California
  19. Templeton, California
  20. Torrance, California
  21. Denver, Colorado
  22. Englewood, Colorado
  23. Glenwood Springs, Colorado
  24. Norwich, Connecticut
  25. Stamford, Connecticut
  26. Bay Pines, Florida
  27. Daytona Beach, Florida
  28. Fort Lauderdale, Florida
  29. Fort Myers, Florida
  30. Hialeah, Florida
  31. Lakewood Ranch, Florida
  32. Naples, Florida
  33. Naples, Florida
  34. Albany, Georgia
  35. Atlanta, Georgia
  36. Newnan, Georgia
  37. Thomasville, Georgia
  38. Boise, Idaho
  39. Coeur d'Alene, Idaho
  40. Chicago, Illinois
  41. Crystal Lake, Illinois
  42. Glenview, Illinois
  43. Hines, Illinois
  44. North Chicago, Illinois
  45. Urbana, Illinois
  46. Greenwood, Indiana
  47. Jeffersonville, Indiana
  48. Lafayette, Indiana
  49. Davenport, Iowa
  50. Wichita, Kansas
  51. Wichita, Kansas
  52. Ashland, Kentucky
  53. Baton Rouge, Louisiana
  54. Covington, Louisiana
  55. Houma, Louisiana
  56. New Orleans, Louisiana
  57. New Orleans, Louisiana
  58. Shreveport, Louisiana
  59. Lewiston, Maine
  60. Bethesda, Maryland
  61. Greenbelt, Maryland
  62. Towson, Maryland
  63. Worcester, Massachusetts
  64. Worcester, Massachusetts
  65. Detroit, Michigan
  66. Lansing, Michigan
  67. Royal Oak, Michigan
  68. Troy, Michigan
  69. Duluth, Minnesota
  70. Minneapolis, Minnesota
  71. Saint Cloud, Minnesota
  72. Saint Louis Park, Minnesota
  73. Woodbury, Minnesota
  74. Tupelo, Mississippi
  75. Bolivar, Missouri
  76. Columbia, Missouri
  77. Saint Louis, Missouri
  78. Billings, Montana
  79. Billings, Montana
  80. Missoula, Montana
  81. Fremont, Nebraska
  82. Grand Island, Nebraska
  83. Omaha, Nebraska
  84. Omaha, Nebraska
  85. Belleville, New Jersey
  86. Berkeley Heights, New Jersey
  87. Edison, New Jersey
  88. Englewood, New Jersey
  89. Paramus, New Jersey
  90. Voorhees, New Jersey
  91. Albuquerque, New Mexico
  92. Santa Fe, New Mexico
  93. Albany, New York
  94. Bronx, New York
  95. Buffalo, New York
  96. Cheektowaga, New York
  97. East Setauket, New York
  98. Garden City, New York
  99. Jamaica, New York
  100. Manhattan, New York
  101. Mineola, New York
  102. North Hills, New York
  103. Poughkeepsie, New York
  104. Syracuse, New York
  105. Asheville, North Carolina
  106. Concord, North Carolina
  107. Durham, North Carolina
  108. Gastonia, North Carolina
  109. Greenville, North Carolina
  110. Hendersonville, North Carolina
  111. High Point, North Carolina
  112. Pinehurst, North Carolina
  113. Raleigh, North Carolina
  114. Washington, North Carolina
  115. Winston-Salem, North Carolina
  116. Winston-Salem, North Carolina
  117. Cincinnati, Ohio
  118. Middleburg Heights, Ohio
  119. Oklahoma City, Oklahoma
  120. Oklahoma City, Oklahoma
  121. Coos Bay, Oregon
  122. Corvallis, Oregon
  123. Portland, Oregon
  124. Springfield, Oregon
  125. Bala-Cynwyd, Pennsylvania
  126. Lancaster, Pennsylvania
  127. Pittsburgh, Pennsylvania
  128. Charleston, South Carolina
  129. Myrtle Beach, South Carolina
  130. Watertown, South Dakota
  131. Chattanooga, Tennessee
  132. Cookeville, Tennessee
  133. Nashville, Tennessee
  134. Nashville, Tennessee
  135. Nashville, Tennessee
  136. Dallas, Texas
  137. Fort Worth, Texas
  138. San Antonio, Texas
  139. Temple, Texas
  140. Salt Lake City, Utah
  141. Richmond, Virginia
  142. Richmond, Virginia
  143. Virginia Beach, Virginia
  144. Bellingham, Washington
  145. Everett, Washington
  146. Tacoma, Washington
  147. La Crosse, Wisconsin
  148. Milwaukee, Wisconsin
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
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:No
Plan Description:Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor Astellas Pharma Global Development, Inc.
Collaborators Pfizer
Investigators
Study Director:Medical DirectorAPGD, Medical Affairs, Americas
PRS Account Astellas Pharma Inc
Verification Date July 2020